Enhance access to pulmonary rehabilitation with a structured and personalized home-based program—reabilitAR: protocol for real-world setting

In e na ional Jou nal o En i onmen al Resea ch and Public Heal h P o ocol Enhance Access o Pulmona y Rehabili a ion wi h a S uc u ed and Pe sonalized Home-Based P og am— eabili AR: P o ocol o Real-Wo ld Se ing Sa ah Be na d 1,†, Rui Vila inho 2,† , Inês Pin o 2, Rosa Can an e 2, Rica do Coxo 2, Rosa Fonseca 2, Sag a io Mayo alas-Alises 3, Sal ado Diaz-Loba o 4,5, João Ca alho 2,6, Cá ia Es e es 2and Cá ia Canei as 2,7,8,*   Ci a ion: Be na d, S.; Vila inho, R.; Pin o, I.; Can an e, R.; Coxo, R.; Fonseca, R.; Mayo alas-Alises, S.; Diaz-Loba o, S.; Ca alho, J.; Es e es, C.; e al. Enhance Access o Pulmona y Rehabili a ion wi h a S uc u ed and Pe sonalized Home-Based P og am— eabili AR: P o ocol o Real-Wo ld Se ing. In . J. En i on. Res. Public Heal h 2021,18, 6132. h ps://doi.o g/10.3390/ ije ph18116132 Academic Edi o s: Ch is oph Gu enb unne and Boya Nug aha Recei ed: 21 Ap il 2021 Accep ed: 3 June 2021 Published: 6 June 2021 Publishe ’s No e: MDPI s ays neu al wi h ega d o ju isdic ional claims in published maps and ins i u ional a il- ia ions. Copy igh : © 2021 by he au ho s. Licensee MDPI, Basel, Swi ze land. This a icle is an open access a icle dis ibu ed unde he e ms and condi ions o he C ea i e Commons A ibu ion (CC BY) license (h ps:// c ea i ecommons.o g/licenses/by/ 4.0/). 1Cen e de Reche che, Ins i u Uni e si ai e de Ca diologie e de Pneumologie de Québec, Uni e si éLa al, Québec, QC G1V 4G5, Canada; [email p o ec ed] 2Heal hca e Depa men , Nippon Gases Po ugal, 4470-177 Maia, Po ugal; [email p o ec ed] (R.V.); [email p o ec ed] (I.P.); [email p o ec ed] (R.C.); [email p o ec ed] (R.C.); [email p o ec ed] (R.F.); [email p o ec ed] (J.C.); [email p o ec ed] (C.E.) 3Heal hca e Managemen Depa men , Hospi al Qui ón Salud San José, 28002 Mad id, Spain; [email p o ec ed] 4Nippon Gases Heal hca e, 28020 Mad id, Spain; sal ado [email p o ec ed] 5Se ice o Pneumology, Hospi al Uni e si a io Moncloa, 28008 Mad id, Spain 6 Depa men o Pulmonology, Cen o Hospi ala Uni e si á io Lisboa No e, Lisbon Academic Medical Cen e , 1649-028 Lisbon, Po ugal 7Mic obiology Resea ch Labo a o y on En i onmen al Heal h (En iHeal hMic oLab), Ins i u e o En i onmen al Heal h (ISAMB), Facul y o Medicine, Uni e si y o Lisbon, 1649-028 Lisbon, Po ugal 8Ins i u e o P e en i e Medicine and Public Heal h, Facul y o Medicine, Uni e si y o Lisbon, 1649-028 Lisbon, Po ugal *Co espondence: [email p o ec ed] † These au ho s con ibu ed equally o his wo k. Abs ac : Home-based models ep esen one o he solu ions o espond o he poo accessibili y o pulmona y ehabili a ion (PR) se ices in pa ien s wi h ch onic espi a o y disease (CRD). The main goal o his p o ocol is o p esen he implemen a ion o he i s na ionwide home-based PR p og am— eabili AR—in Po ugal and he s a egies o assess i s bene i s in pa ien s wi h CRD. The p og am consis s o 2 phases: a 12-week in ensi e phase and a 40-week main enance phase ( o al: 52 weeks, 1 yea ). The in e en ion in bo h phases is composed o p esen ial home isi s and phone-call ollow ups, including exe cise aining and he sel -managemen educa ional p og am Li ing Well wi h COPD. Dyspnea, impac o he disease, emo ional s a us, and le el o dyspnea du ing ac i i ies o daily li ing a e used as pa ien - epo ed ou comes measu es. A one-minu e si - o-s and es is used as a unc ional ou come, and he numbe o s eps as a measu e o physical ac i i y. To ensu e sa e y, all isk and he cogni i e unc ion a e assessed. Da a a e collec ed a baseline, a 12 weeks, a 26 weeks and a 52 weeks. This is he i s na ionwide p o ocol on enhancing access o PR, p o iding app op ia e esponses o CRD pa ien s’ needs h ough a s uc u ed and pe sonalized home-based p og am in Po ugal. Keywo ds: ch onic espi a o y diseases; COPD; exe cise aining; sel -managemen ; quali y o li e 1. In oduc ion The Wo ld Heal h O ganiza ion (WHO) indica es ha hund eds o millions o people wo ldwide a e a ec ed by ch onic espi a o y diseases (CRD), including ch onic obs uc- i e pulmona y disease (COPD) [ 1 ]. These condi ions associa ed wi h dyspnea, a igue [ 2 ], oge he wi h muscle dys unc ion [ 3 ], a e an impo an cause o disabili y. These im- pai men s a e also associa ed wi h educed heal h- ela ed quali y-o -li e (HRQoL) [ 4 , 5 ], inc eased exace ba ion a es [6–8] and mo ali y [9]. In . J. En i on. Res. Public Heal h 2021,18, 6132. h ps://doi.o g/10.3390/ije ph18116132 h ps://www.mdpi.com/jou nal/ije ph In . J. En i on. Res. Public Heal h 2021,18, 6132 2 o 12 Pulmona y ehabili a ion (PR) is an essen ial componen in he managemen o CRD wi h he aim o imp o e pa ien s’ exe cise and unc ional capaci y and psychological condi ion wi h long- e m adhe ence o heal h-enhancing beha io s, including exe cise aining and sel -managemen skills [ 10 – 12 ]. This beha io change also esul s in heal h economic gains due o ewe hospi al admissions [ 13 ]. Thus, PR is a cos -e ec i e ea men and has been p oposed o be pa o he s anda d ca e o e ed o pa ien s wi h CRD [ 10 ]. Howe e , despi e he well-known e idence, his se ice is la gely unde u ilized due o poo accessibili y, wi h only 1% o wo ldwide a ailabili y o PR se ices o COPD pa ien s [ 14 ]. In Po ugal, his lack o access is obse ed due o he insu icien esponse o he exis ing p og ams, mos o hem hospi al-based [ 15 ]. Howe e , i is also obse ed by he ba ie s and limi a ions, which includes he absence o p og ams in non-u ban geog aphic a eas, lack o pe cei ed bene i s o PR, poo a ailabili y o ma e ials and heal h p o essionals o c ea e new p og ams, and lack o unding by he Na ional Heal h Se ice (NHS) o heal h subsys ems [15,16]. Thus, i is impo an o unde ake ac ions ha imp o e access o and deli e y o PR se ices o sui able pa ien s. One o he s a egies in he in e na ional guidelines is he c ea ion o new models o p og ams, whe e a home-based app oach is indica ed [ 17 ]. Home-based PR models, de eloped a ound he wo ld, p esen ed equi alen bene i s o hospi al-based p og ams in HRQoL and exe cise capaci y wi h no se ious ad e se e en s [18,19]. Acco ding o hese posi i e esul s, he eabili AR p og am was c ea ed on a alue- added model o ca e ha can con ibu e o inc ease he access o pa ien s wi h CRD in Po ugal. Addi ionally, his p og am p o ides a sa e home-based PR o high quali y wi h a di ec assessmen on he pa ien s’ needs, and he en i onmen in which PR is conduc ed. I s implemen a ion makes i he i s na ionwide, s uc u ed, and pe sonalized home-based PR in Po ugal. The goal o his p ojec is o p esen and implemen he home-based PR p og am— eabili AR—in pa ien s wi h CRD. The main ou comes a e o measu e he sho - and long- e m e ec s o his speci ic home-based p og am on pa ien s’ symp oms, he impac o he disease, emo ional s a us, unc ional capaci y, and le el o physical ac i i y. The seconda y ou comes a e o in es iga e he sho - and long- e m e ec s in he numbe o exace ba ions and heal hca e u iliza ion. The i s popula ion included in his p og am we e COPD pa ien s because hey ep esen he la ges p opo ion o e e als in PR and much o he exis ing ela ed e idence is in his popula ion [10]. 2. Ma e ials and Me hods 2.1. Design, Se ing and Medical Re e als A eal-wo ld p e- and pos -in e en ion p o ocol was designed o pa ien s wi h CRD. The i s s ep in he de elopmen o he eabili AR p og am was building an ope a ional in- s uc ion manual acco ding o he bes p ac ices and in e na ional guidelines [10,17,20,21] . The in e en ion p o ocol was elabo a ed o sys ema ize he p ocedu es by he eabili- AR eam and o ensu e he quali y o he PR in e en ion, since all he p ocedu es o he p og am a e applied a he pa ien s’ homes, including he assessmen momen s and in e en ion. The eabili AR eam is cons i u ed by heal hca e p o essionals, including a pulmonolo- gis ( esponsible o he assessmen o e e als o he p og am acco ding o he clinical epo s, o he pa ien s’ inclusion, and he managemen o medical incidences and sa e y du ing he p og am), a espi a o y nu se ( he case manage , esponsible o coo dina ing pa ien ca e by acili a ing communica ion wi h he eam o ensu e egula p og ess and p oblem assessmen s, mo i a ion and con idence building, and p oblem-sol ing suppo ) and a ained physio he apis (mainly esponsible o he exe cise aining and assessmen s). The p og am also p esen s he collabo a ion o a nu i ionis , a ca diopulmona y echnician, a pha macis , and a psychologis , al hough hey do no ha e a di ec app oach in pa ien s’ in e en ion, hey help he o he eam membe s in he decisions making (Figu e 1). The whole eam wo ks o o Nippon Gases Po ugal, a home espi a o y ca e p o ide which is In . J. En i on. Res. Public Heal h 2021,18, 6132 3 o 12 homologa ed by he Po uguese NHS o he p o ision o domicilia y espi a o y he apies (oxygen, non-in asi e en ila ion, and o he espi a o y he apies) and i is ce i ied wi h scien i ic sui abili y by he Na ional Inno a ion Agency (ANI) o Po ugal. In . J. En i on. Res. Public Heal h 2021, 18, x 3 o 13 coo dina ing pa ien ca e by acili a ing communica ion wi h he eam o ensu e egula p og ess and p oblem assessmen s, mo i a ion and con idence building, and p oblem-sol ing suppo ) and a ained physio he apis (mainly esponsible o he exe cise aining and assessmen s). The p og am also p esen s he collabo a ion o a nu i ionis , a ca diopulmona y echnician, a pha macis , and a psychologis , al hough hey do no ha e a di ec app oach in pa ien s’ in e en ion, hey help he o he eam membe s in he decisions making (Figu e 1). The whole eam wo ks o o Nippon Gases Po ugal, a home espi a o y ca e p o ide which is homologa ed by he Po uguese NHS o he p o ision o domicilia y espi a o y he apies (oxygen, non-in asi e en ila ion, and o he espi a o y he apies) and i is ce i ied wi h scien i ic sui abili y by he Na ional Inno a ion Agency (ANI) o Po ugal. Figu e 1. Membe s o he eabili AR p og am. Pa ien s a e e e ed by pulmonologis s om medical consul a ion in hospi als and clinics, and in he u u e gene al p ac i ione s will also be able o e e . The e e al p ocess consis s o comple ing a documen , wi h equi ed in o ma ion such as espi a o y diagnosis, o he como bidi ies diagnoses, usual medica ion, and medical examina ions (mainly, pulmona y unc ion es ing, and elec oca diog am [ECG]). Du ing he p ocess i is also expec ed ha he medical doc o explains he goal and bene i s o PR, acco ding o he eabili AR p og am. Eligible pa ien s con ac o a e con ac ed by he eabili AR eam, o addi ional ques ions and o begin he in eg a ion p ocess. 2.2. Eligibili y C i e ia Pa ien s a e eligible i hey a e diagnosed wi h CRD. Speci ically, COPD pa ien s ha e o mee he ollowing inclusion c i e ia: (i) diagnosis based on he Global Ini ia i e o Ch onic Obs uc i e Lung Disease (GOLD) c i e ia—pos b onchodila o o ced expi a o y olume in 1 s (FEV 1 )/ o ced i al capaci y (FVC) a io <70% [20]; (ii) ECG eco d a es wi h no signi ican change; (iii) w i en in o med consen o m. Exclusion c i e ia a e: (i) p esence o any clinical condi ion ha does no allow he pa icipa ion o a home- based PR p og am, such as, signi ican ca dio ascula (e.g., symp oma ic ischemic ca diac disease), neu ological (e.g., neu omuscula dys ophy disease) o p esence o musculoskele al disease; (ii) signs o cogni i e impai men (e.g., demen ia) [22]. 2.3. Da a Collec ion Fo he eligible pa ien s, he case manage p oceeds o a phone-call o a s anda d and s uc u ed assessmen h ough a ques ionnai e, which includes socio-demog aphic (age, sex, educa ional le el, ma i al and wo king s a us), gene al clinical in o ma ion (medica ion, long- e m oxygen, non-in asi e en ila ion, medical his o y, and como bidi ies), ea ing habi s and smoking habi s. This da a collec ion is sen o he physio he apis o schedule he i s home isi o comple e he baseline assessmen . W i en in o med consen is ob ained p io o his baseline da a collec ion. The ou comes measu ed du ing he i s home isi a e: an h opome ic measu es (body mass index— Figu e 1. Membe s o he eabili AR p og am. Pa ien s a e e e ed by pulmonologis s om medical consul a ion in hospi als and clinics, and in he u u e gene al p ac i ione s will also be able o e e . The e e al p ocess consis s o comple ing a documen , wi h equi ed in o ma ion such as espi a o y diagnosis, o he como bidi ies diagnoses, usual medica ion, and medical examina ions (mainly, pulmona y unc ion es ing, and elec oca diog am [ECG]). Du ing he p ocess i is also expec ed ha he medical doc o explains he goal and bene i s o PR, acco ding o he eabili AR p og am. Eligible pa ien s con ac o a e con ac ed by he eabili AR eam, o addi ional ques ions and o begin he in eg a ion p ocess. 2.2. Eligibili y C i e ia Pa ien s a e eligible i hey a e diagnosed wi h CRD. Speci ically, COPD pa ien s ha e o mee he ollowing inclusion c i e ia: (i) diagnosis based on he Global Ini ia i e o Ch onic Obs uc i e Lung Disease (GOLD) c i e ia—pos b onchodila o o ced expi a o y olume in 1 s (FEV 1 )/ o ced i al capaci y (FVC) a io <70% [ 20 ]; (ii) ECG eco d a es wi h no signi ican change; (iii) w i en in o med consen o m. Exclusion c i e ia a e: (i) p esence o any clinical condi ion ha does no allow he pa icipa ion o a home-based PR p og am, such as, signi ican ca dio ascula (e.g., symp oma ic ischemic ca diac dis- ease), neu ological (e.g., neu omuscula dys ophy disease) o p esence o musculoskele al disease; (ii) signs o cogni i e impai men (e.g., demen ia) [22]. 2.3. Da a Collec ion Fo he eligible pa ien s, he case manage p oceeds o a phone-call o a s anda d and s uc u ed assessmen h ough a ques ionnai e, which includes socio-demog aphic (age, sex, educa ional le el, ma i al and wo king s a us), gene al clinical in o ma ion (med- ica ion, long- e m oxygen, non-in asi e en ila ion, medical his o y, and como bidi ies), ea ing habi s and smoking habi s. This da a collec ion is sen o he physio he apis o schedule he i s home isi o comple e he baseline assessmen . W i en in o med con- sen is ob ained p io o his baseline da a collec ion. The ou comes measu ed du ing he i s home isi a e: an h opome ic measu es (body mass index—BMI, wais and hip ci cum e ence, wais - o-heigh and wais - o-hip a io, and % body a , % o wa e and a ee body mass wi h bioelec ical impedance measu e—Tani a BC-545 N, Tani a, Ams e - dam, The Ne he lands) [ 23 , 24 ]; symp oms o dyspnea (modi ied Medical Resea ch Council Ques ionnai e—mMRC) [ 25 ], impac o he disease (COPD Assessmen Tes —CAT) [ 26 , 27 ], emo ional s a us (The Hospi al Anxie y and Dep ession Scale—HADS) [ 28 , 29 ], le el o dys- pnea du ing ac i i ies o daily li ing (London Ches Ac i i y o Daily Li ing—LCADL) [ 30 ], unc ional capaci y (1-minu e si - o-s and es —1MSTS) [ 31 ], and physical ac i i y (pe- dome e ) [ 32 ]. To ensu e he sa e y du ing he sel -managed exe cise aining sessions, he In . J. En i on. Res. Public Heal h 2021,18, 6132 4 o 12 assessmen o cogni i e unc ion (Mini-Men al S a e Examina ion—MMSE) [ 33 , 34 ] and balance/ all isk (Be g Balance Scale—BBS and Sho Fo m Be g Balance Scale 3-Poin — SFBBS-3P) [ 35 , 36 ] a e also included. The SFBBS-3P is applied in e e y pa ien as a sc eening o all isk and only he posi i e ones a e assessed wi h BBS o ealize he deg ee o all isk p esen ed. This analysis is impo an and could change he s anda d scheme o isi s o he eabili AR p og am p esen ed below, by adding isi s a he beginning o he p o- g am o o e a speci ic exe cise p og am o all isk o a subsequen sa e and e ec i e sel -managemen in e en ion. Du ing his baseline assessmen is also assessed he sel -e icacy o he abili y o ollow he exe cise p og am egula ly ( ≥ 3 days a week) o e he eabili AR p og am, conside ing a scale o 1 o 10, whe e 10 ep esen s “ e y con iden ”. This e alua ion is adap ed om he LWWCOPD. Fu he mo e, pa ien s a e asked he expec a ions/objec i es hey p e end o achie e wi h he p og am, always e lec ing he unc ional pe o mance (acco ding o he eal-li e si ua ions and di icul ies in usually pe o m hei ac i i ies) [37]. A e he baseline assessmen , he pulmonologis o he p og am alida es he inclu- sion o pa ien s acco ding o his analysis o he collec ed da a (especially, ECG, como bidi- ies, ou comes, and all isk), ensu ing he sa e y o he home-based app oach. Du ing he p og am, da a a e also collec ed om pa ien s a 12 weeks (end o in ensi e phase), a 26 weeks (du ing main enance phase) and 52 weeks (end o main enance phase) o he p og am (Table 1). Table 1. Ou comes assessed in each ime poin o he eabili AR p og am. Timepoin Baseline T0 Pos 12 Weeks T1 Pos 26 Weeks T2 Pos 52 Weeks T3 In e en ion Home-Based Pulmona y Rehabili a ion— eabili AR Ou comes An h opome ic measu es X X X X Impac o he disease X X X X Emo ional s a us X X X X Balance and all isk X X X X Cogni i e unc ion X Func ional capaci y X X X X Numbe o exace ba ions and hospi al admissions X X X X Le el o physical ac i i y X X X X 2.4. In e en ion The p og am consis s o 2 phases: a 12-week in ensi e phase and a 40-week main- enance phase o a o al du a ion o 52 weeks (1 yea ). In e en ion in bo h phases consis s o a hyb id concep ion o p esen ial home isi s o he exe cise aining and he sel -managemen sessions, and phone-call ollow-ups including mo i a ional ollow-up, assessmen o he clinical condi ion, and he p og ession o exe cise aining. The in ensi e phase (week 1 o 12) includes a o al o 14 home isi s, wi h mo e isi s in he i s wo weeks o he p og am (4 isi s). F om he hi d week, one isi is eplaced by a phone-call, o a o al o 10 phone-calls (Figu e 2). The gene al objec i e o his s a egic combina ion o in e en ions is o empowe he pa ien s o each a equency o exe cise aining be- ween 3 and 5 imes pe week [ 10 ], o be e ake con ol o hei heal h beha io aiming o he sel -managemen o hei heal h condi ions. Addi ionally, o p o ide knowledge and s a egies o cope wi h he appea ance o possible limi ing ac o s du ing he p og am, like de ec ing signs and symp oms o s op exe cise aining. In . J. En i on. Res. Public Heal h 2021,18, 6132 5 o 12 In . J. En i on. Res. Public Heal h 2021, 18, x 5 o 13 o a o al o 10 phone-calls (Figu e 2). The gene al objec i e o his s a egic combina ion o in e en ions is o empowe he pa ien s o each a equency o exe cise aining be ween 3 and 5 imes pe week [10], o be e ake con ol o hei heal h beha io aiming o he sel -managemen o hei heal h condi ions. Addi ionally, o p o ide knowledge and s a egies o cope wi h he appea ance o possible limi ing ac o s du ing he p og am, like de ec ing signs and symp oms o s op exe cise aining. Figu e 2. S anda d numbe o isi s and phone-calls du ing he in ensi e phase. In he main enance phase, weeks 13 o 26, he in e en ion emains he same, wi h one home isi and one phone call pe week. Du ing weeks 27 o 52, s a s a 4-week cycle in e en ion wi h 3 isi s in he i s weeks and one phone-call on he las week (Figu e 3). Figu e 3. S anda d numbe o isi s and phone-calls du ing he main enance phase. The eabili AR p og am includes he sel -managemen educa ional p og am Li ing Well wi h COPD (LWWCOPD) (a ailable a www.li ingwellwi hcopd.com). Each home isi has a du a ion o 60 min and is deli e ed by a physio he apis which includes a clinical assessmen (symp oms, hea a e (HR), blood p essu e (BP), oxygen sa u a ion (SpO2) and pe cei ed dyspnea and a igue wi h he modi ied Bo g scale), he eaching o he exe cise aining and he sel -managemen educa ional in e en ion. The exe cise aining is pe o med acco ding o he module “In eg a ing an Exe cise P og am in o You Li e” o LWWCOPD and includes wa m-up, endu ance, esis ance/s eng h, lexibili y, balance aining and a cool down pe iod. E e y session he physio he apis e isi s he na u e o he exe cise, i s equency, du a ion, in ensi y, and p og ession. The endu ance aining is pe o med on a po able cyclo-e gome e s and s eps/s ai s o a a ge du a ion o 30 min pe session and he aining in ensi y measu ed and limi ed o a Bo g dyspnea o a igue sco e o 4 o 6 [10,18]. The esis ance/s eng h aining is pe o med using a a ie y o ools such as dumbbells, ankle weigh s and elas ic bands o up o 20 min wi h exe cises o he majo uppe limbs, lowe limbs, and unk muscle g oups. Ini ial loads equi alen o one ha e okes a igue a e 10–12 epe i ions, wi h 1 o 3 se s [10]. The lexibili y and balance aining componen a e pe o med acco ding o he pa ien s’ need. Figu e 2. S anda d numbe o isi s and phone-calls du ing he in ensi e phase. In he main enance phase, weeks 13 o 26, he in e en ion emains he same, wi h one home isi and one phone call pe week. Du ing weeks 27 o 52, s a s a 4-week cycle in e en ion wi h 3 isi s in he i s weeks and one phone-call on he las week (Figu e 3). In . J. En i on. Res. Public Heal h 2021, 18, x 5 o 13 o a o al o 10 phone-calls (Figu e 2). The gene al objec i e o his s a egic combina ion o in e en ions is o empowe he pa ien s o each a equency o exe cise aining be ween 3 and 5 imes pe week [10], o be e ake con ol o hei heal h beha io aiming o he sel -managemen o hei heal h condi ions. Addi ionally, o p o ide knowledge and s a egies o cope wi h he appea ance o possible limi ing ac o s du ing he p og am, like de ec ing signs and symp oms o s op exe cise aining. Figu e 2. S anda d numbe o isi s and phone-calls du ing he in ensi e phase. In he main enance phase, weeks 13 o 26, he in e en ion emains he same, wi h one home isi and one phone call pe week. Du ing weeks 27 o 52, s a s a 4-week cycle in e en ion wi h 3 isi s in he i s weeks and one phone-call on he las week (Figu e 3). Figu e 3. S anda d numbe o isi s and phone-calls du ing he main enance phase. The eabili AR p og am includes he sel -managemen educa ional p og am Li ing Well wi h COPD (LWWCOPD) (a ailable a www.li ingwellwi hcopd.com). Each home isi has a du a ion o 60 min and is deli e ed by a physio he apis which includes a clinical assessmen (symp oms, hea a e (HR), blood p essu e (BP), oxygen sa u a ion (SpO2) and pe cei ed dyspnea and a igue wi h he modi ied Bo g scale), he eaching o he exe cise aining and he sel -managemen educa ional in e en ion. The exe cise aining is pe o med acco ding o he module “In eg a ing an Exe cise P og am in o You Li e” o LWWCOPD and includes wa m-up, endu ance, esis ance/s eng h, lexibili y, balance aining and a cool down pe iod. E e y session he physio he apis e isi s he na u e o he exe cise, i s equency, du a ion, in ensi y, and p og ession. The endu ance aining is pe o med on a po able cyclo-e gome e s and s eps/s ai s o a a ge du a ion o 30 min pe session and he aining in ensi y measu ed and limi ed o a Bo g dyspnea o a igue sco e o 4 o 6 [10,18]. The esis ance/s eng h aining is pe o med using a a ie y o ools such as dumbbells, ankle weigh s and elas ic bands o up o 20 min wi h exe cises o he majo uppe limbs, lowe limbs, and unk muscle g oups. Ini ial loads equi alen o one ha e okes a igue a e 10–12 epe i ions, wi h 1 o 3 se s [10]. The lexibili y and balance aining componen a e pe o med acco ding o he pa ien s’ need. Figu e 3. S anda d numbe o isi s and phone-calls du ing he main enance phase. The eabili AR p og am includes he sel -managemen educa ional p og am Li ing Well wi h COPD (LWWCOPD) (a ailable a www.li ingwellwi hcopd.com, accessed on 3 June 2021). Each home isi has a du a ion o 60 min and is deli e ed by a physio he apis which includes a clinical assessmen (symp oms, hea a e (HR), blood p essu e (BP), oxygen sa u a ion (SpO 2 ) and pe cei ed dyspnea and a igue wi h he modi ied Bo g scale), he eaching o he exe cise aining and he sel -managemen educa ional in e en ion. The exe cise aining is pe o med acco ding o he module “In eg a ing an Exe cise P og am in o You Li e” o LWWCOPD and includes wa m-up, endu ance, esis ance/s eng h, lexibili y, balance aining and a cool down pe iod. E e y session he physio he apis e isi s he na u e o he exe cise, i s equency, du a ion, in ensi y, and p og ession. The endu ance aining is pe o med on a po able cyclo-e gome e s and s eps/s ai s o a a ge du a ion o 30 min pe session and he aining in ensi y measu ed and limi ed o a Bo g dyspnea o a igue sco e o 4 o 6 [ 10 , 18 ]. The esis ance/s eng h aining is pe o med using a a ie y o ools such as dumbbells, ankle weigh s and elas ic bands o up o 20 min wi h exe cises o he majo uppe limbs, lowe limbs, and unk muscle g oups. Ini ial loads equi alen o one ha e okes a igue a e 10–12 epe i ions, wi h 1 o 3 se s [ 10 ]. The lexibili y and balance aining componen a e pe o med acco ding o he pa ien s’ need. Flexibili y aining is done using s e ching exe cises o he majo muscle g oups [ 10 ] and balance aining wi h pos u al exe cises, ansi ion, and gai exe cises [ 38 , 39 ]. Du ing he p og am, p og ession o he aining in ensi y is also ailo ed acco ding o he pe cei ed dyspnea and a igue using he modi ied Bo g scale. All he ma e ial men ioned abo e o he exe cise aining is p o ided o each pa ien by he homeca e p o ide esponsible o he p og am. Addi ionally, a modi ied Bo g scale and a dia y is o e ed o egis e hei exe cise aining du ing he unsupe ised sessions. I is also asked o egis e any symp oms wo sening o exace ba ions, changes in medica ion o o he aspec s ha hey ca e o epo o he physio he apis o he case manage , acco ding o he sel -managemen concep . In . J. En i on. Res. Public Heal h 2021,18, 6132 6 o 12 The sel -managemen educa ional in e en ion is based on he modules o LWWCOPD and is pe o med especially du ing he in ensi e phase o he p og am. Beside he module on exe cise aining, each pa ien ecei es one o he module en i led “Being Heal hy wi h COPD”, ha includes e e y educa ional opic conce ning sel -managemen (4). I needed, he o he modules p esen ed in LWWCOPD a e a ailable acco ding o he pa ien s’ speci ic needs. A de ailed desc ip ion and he selec ed o de o he hemes a e p esen ed in Table 2. Table 2. Modules and educa ional opics p oposed o he home isi s o he in ensi e phase (14 isi s). Sel -Managemen Educa ional In e en ion Visi Module Themes 1In eg a ing an Exe cise P og am in o You Li e Exe cise p og am, pu sed-lip b ea hing echnique and scale o pe cei ed exe ion 2Being Heal hy wi h COPD—P e en ing you Symp oms and Taking You Medica ion Ana omy, physiology and cause o COPD and ac o s ha can make you symp oms wo se 3 Medica ions and inhala ion echniques 4 Managing you B ea hing and Sa ing You Ene gy Unde s anding how b ea hing wo ks, educing sho ness o b ea h (b ea hing echniques and body posi ions) 5 Clea ing you ai ways (coughing ecniques, ac i e cycle o b ea hing echnique and de ices) 6 Clea ing you ai ways (de ices) 7 Applying ene gy conse a ion p inciples 8 Re iew o p e ious hemes (doub s) and ein o ce he impo ance o medica ions and b ea hing echniques/body posi ions o sho ness o b ea h 9 Managing You S ess & Anxie y Iden i ying he s esso s in you li e and unde s anding you eac ion, b eaking he anxie y-b ea hlessness cycle 10 Associa e he opics o isi 4 and isi 9 11 Managing You S ess & Anxie y In eg a ing elaxa ion exe cises and applying ules o li e a heal hie li e 12 In eg a ing a Heal hy Die in o You Li e The link be ween COPD and wha you ea , main aining a heal hy weigh and heal hy and balanced ea ing 13 Keeping a Heal hy and Ful illing Li es yle Being heal hy, qui ing smoking (op ional), sleeping be e , sa is ying sex li e, leisu e ac i i ies and a elling 14 Re iew o p e ious hemes (doub s) Pa ien s also ecei e a pedome e and ecommenda ions on how o use i o inc ease physical ac i i y. An o e iew o he imeline and p ocedu es o he eabili AR p og am is a ailable in Figu e 4. In . J. En i on. Res. Public Heal h 2021,18, 6132 7 o 12 In . J. En i on. Res. Public Heal h 2021, 18, x 7 o 13 Figu e 4. O e iew o he imeline and p ocedu es o he eabili AR p og am. 2.5. S a is ical Analysis A e he assessmen momen s (12 weeks, 26 weeks, and 52 weeks), a epo wi h he o al sco es o pa ien - epo ed ou comes measu es (mMRC, CAT, HADS, LCADL), he pe o mance o he unc ional es ou come (1MSTS), physical ac i i y (numbe o s eps), and he numbe o exace ba ions and heal hca e u iliza ion a e egis e ed along wi h he baseline da a o a e m o compa ison. Acco ding o he a ailable e idence, es ablished minimal clinically impo an di e ences (MCID) a e also included acco ding o he espec i e diagnosis o CRD. This epo is sen o he e e e doc o on each assessmen momen . In o de o de ec he bene i s o he eabili AR p og am in pa ien s wi h COPD, da a om he s udy o Vaidya and colleagues (2016) [31], by using he di e ences in unc ional capaci y assessed wi h he 1MSTS in pa ien s unde going PR, was used o calcula e he e ec size and o es ima e he sample size. The nex o mula was used: E ec size = [(mean pos − mean p e)/SD di e ence] (1) whe e “mean pos ” is he mean o he numbe o epe i ions a e PR, “mean p e” is he mean o he numbe o epe i ions be o e PR, and “SD di e ence” is he s anda d de ia ion o he mean change. The di e ence be ween pos - and p e- numbe o epe i ions achie ed in Vaidya s udy (2016) was 3.8 epe i ions and he SD o his di e ence was 4.2 [31], esul ing in an e ec size o 0.90. The e o e, a o al sample size o 14 pa ien s will be conside ed o explo e he i s esul s o he eabili AR p og am. Fo his pu pose, we will include 25 pa ien s in ou ec ui men since PR p og ams ha e conside able d opou a es, a ying be ween 20 and 40% [40]. We a e p edic ing o each his ec ui men goal be ween 6 mon hs and 1 yea . S a is ical analyses will be pe o med using IBM SPSS S a is ics (IBM Co po a ion, No h Cas le, NY, USA) wi h a le el o signi icance o 0.05. Desc ip i e s a is ics ( equencies, means and s anda d de ia ions, medians, and in e qua ile anges) will be used o desc ibe he pa ien s. The bene i s o he eabili AR p og am will be e i ied using pai ed - es o Wilcoxon signed- ank es s, acco dingly o da a no mali y. Di e ences be ween he di e en ime poin s will be assessed using a one-way analysis o a iance wi h epea ed measu es o es ablish he signi ican e ec s o ime. Wi h a signi ican e ec o ime, pos hoc analyses will be made wi h pai wise compa isons using he Bon e oni co ec ion. Figu e 4. O e iew o he imeline and p ocedu es o he eabili AR p og am. 2.5. S a is ical Analysis A e he assessmen momen s (12 weeks, 26 weeks, and 52 weeks), a epo wi h he o al sco es o pa ien - epo ed ou comes measu es (mMRC, CAT, HADS, LCADL), he pe o mance o he unc ional es ou come (1MSTS), physical ac i i y (numbe o s eps), and he numbe o exace ba ions and heal hca e u iliza ion a e egis e ed along wi h he baseline da a o a e m o compa ison. Acco ding o he a ailable e idence, es ablished minimal clinically impo an di e ences (MCID) a e also included acco ding o he espec i e diagnosis o CRD. This epo is sen o he e e e doc o on each assessmen momen . In o de o de ec he bene i s o he eabili AR p og am in pa ien s wi h COPD, da a om he s udy o Vaidya and colleagues (2016) [ 31 ], by using he di e ences in unc ional capaci y assessed wi h he 1MSTS in pa ien s unde going PR, was used o calcula e he e ec size and o es ima e he sample size. The nex o mula was used: E ec size = [(mean pos −mean p e)/SD di e ence] (1) whe e “mean pos ” is he mean o he numbe o epe i ions a e PR, “mean p e” is he mean o he numbe o epe i ions be o e PR, and “SD di e ence” is he s anda d de ia ion o he mean change. The di e ence be ween pos - and p e- numbe o epe i ions achie ed in Vaidya s udy (2016) was 3.8 epe i ions and he SD o his di e ence was 4.2 [ 31 ], esul ing in an e ec size o 0.90. The e o e, a o al sample size o 14 pa ien s will be conside ed o explo e he i s esul s o he eabili AR p og am. Fo his pu pose, we will include 25 pa ien s in ou ec ui men since PR p og ams ha e conside able d opou a es, a ying be ween 20 and 40% [ 40 ]. We a e p edic ing o each his ec ui men goal be ween 6 mon hs and 1 yea . S a is ical analyses will be pe o med using IBM SPSS S a is ics (IBM Co po a ion, No h Cas le, NY, USA) wi h a le el o signi icance o 0.05. Desc ip i e s a is ics ( equen- cies, means and s anda d de ia ions, medians, and in e qua ile anges) will be used o desc ibe he pa ien s. The bene i s o he eabili AR p og am will be e i ied using pai ed - es o Wilcoxon signed- ank es s, acco dingly o da a no mali y. Di e ences be ween he di e en ime poin s will be assessed using a one-way analysis o a iance wi h epea ed measu es o es ablish he signi ican e ec s o ime. Wi h a signi ican e ec o ime, pos hoc analyses will be made wi h pai wise compa isons using he Bon e oni co ec ion. 3. Discussion This eal-wo ld p o ocol p esen s he i s na ionwide home-based PR p og am in Po ugal, ocusing on enhancing pa ien s’ access o PR. Du ing he de elopmen o his p og am, he collabo a ion o na ional and in e na ional clinical expe s in PR has ensu ed he highes s anda ds, wi h a s uc u ed and pe sonalized in e en ion. These s a egies In . J. En i on. Res. Public Heal h 2021,18, 6132 8 o 12 allowed o inc ease he quali y o eabili AR p og am con en , which is he mos impo an ac o in he de elopmen o PR p og ams. This s a emen is p o ed by he e idence, whe e he bene i s o he s uc u ed home-based models a e al eady compa able o hose ob ained wi h he hospi al-based PR [ 18 ], which makes he con en o a PR p og am mo e impo an in de e mining e icacy han he se ing. Addi ionally, o ensu e hese highes s anda ds, he well-known, alida ed, and e ec i e sel -managemen p og am LWWCOPD [ 18 , 41 ], ocusing on beha io change, has been in eg a ed di ec ly in ou p og am. One o he impo an s eps in he de elopmen o ou p og am was he choice o he ou comes measu es o demons a e i s bene i s, since his p og am is o ally conduc ed in he pa ien s’ homes, including he assessmen s momen s and in e en ion. The mMRC, CAT and LCADL a e ecommended by he PR guidelines [ 10 ] and hei adminis a ion is simple, clea , and no ime-consuming. The HADS acili a es he iden i ica ion o ba ie s in luencing he exe cise sel -e icacy and ac o s ha can help c ea e impo an s a egies o he sel -managemen home in e en ion (e.g., iden i ying s esso s o b eak he anxie y- b ea hlessness cycle). In addi ion, his scale p o ides impo an in o ma ion abou anxie y and dep ession symp oms, associa ed wi h men al illness, which can educe HRQoL, inc ease he isk o exace ba ions and mo ali y [ 42 ]. The men al heal h illness opic is ecei ing he mo e a en ion and p io i y in he e idence on in e en ions, including PR, in pa ien s li ing wi h COPD [43]. Fo he assessmen o he physical componen , he 1MSTS was chosen because i equi es limi ed equipmen and space [ 44 ], unlike he mos used es s in PR o exe cise and unc ional capaci ies (e.g., he ield walking es s) [ 45 ]. Addi ionally, his es e lec s a common ac i i y in daily li ing and has good measu emen p ope ies o PR [31,37,46–50] . Addi ionally, he p esence o an ECG eco d a es , wi h no signi ican changes, was also conside ed an impo an and manda o y eligible c i e ion o ensu e sa e y, since he ca dio ascula disease in CRD, especially in COPD, is one o he mos p e alen como bidi ies [ 51 ]. The assessmen o physical ac i i y by he eco d o he numbe o s eps is also an impo an ou come, since people wi h CRD, especially in COPD, p esen low le els o physical ac i i y [ 52 ], which a e associa ed wi h a highe isk o como bidi ies [ 53 ]. Ano he impo an aspec ha he eabili AR p og am could o e is he ull assessmen o he heal h expe ience o pa ien s wi h CRD, acco ding o he In e na ional Classi ica ion o Func ioning, Disabili y, and Heal h (ICF) [ 37 ]. T adi ionally, he assessmen o he pa ien s in he hospi al-based p og ams is only based on wo domains (body unc ions and s uc u es, and ac i i ies) wi h labo a o y-based es s and exe cise es ou comes, ha need o be pe o med in a s anda dized en i onmen . Howe e , hei assessmen s a e no always ep esen a i e o pa ien s’ unc ional capaci y and ue abili y o ul ill hei social oles in he eal-li e si ua ions [ 37 , 54 ]. The home-based app oach is, in ac , an impo an oppo uni y o add a di ec obse a ion and in e en ion o daily li e ac i i ies in pa ien s’ eal en i onmen suppo ed by unc ional measu emen s. In he li e a u e, we can ind e idence ha indica es ha home-based p og ams wi h longe du a ions can ha e longe -las ing bene i s [ 18 ]. Addi ionally, he longi udinal design (1-yea ) o he eabili AR p og am complies one o he ecommenda ions o he ATS/ERS Policy S a emen o he long- e m adhe ence o heal h enhancing beha io s, as a key goal o PR o pa ien s wi h CRD [ 10 ]. Cu en ly, he eali y o he PR in Po ugal is mos ly on hospi al-based p og ams in cen alized u ban a eas [ 15 ], whe e only he assessmen o hei sho - e m e ec s is pe o med, wi hou moni o ing he main enance o he esul s o e ime. To o e come his ba ie , one o he impo an aims o ou p og am is o p o ide an in eg a i e and pa ien -cen e ed ca e wi h a possible ca e ansi ion o he ongoing ehabili a ion p ocess a e hospi al-based PR. This ini ia i e o de elop an al e na i e model o PR e lec s he Po uguese Go e n- men ’s conce ns o p o ide app op ia e esponses o CRD pa ien s’ needs and inc ease hei access o PR acco ding o hei geog aphic dis ibu ion [ 55 ]. I is also ep esen ing a com- p ehensi e and well- esou ced home-based p og am model ha makes e idence-based PR mo e accessible and accep able o pa ien s and paye s [ 17 ]. Fu he mo e, his p og am aims In . J. En i on. Res. Public Heal h 2021,18, 6132 9 o 12 o o e a na ionwide se ice, o imp o e he pa ien s’ HRQoL by educing he disabili ies associa ed wi h he disease, and o imp o e pa ien s’ sel -e icacy and sel -managemen o hei heal h condi ion wi h he app op ia e use o di e en heal h esou ces. I is impo an o acknowledge he limi a ions o his p o ocol. Wi h he in en o implemen a eal-wo ld home-based PR, pa ien s’ e e al o he p og am is manda o ily done h ough a medical doc o , a he han di ec ly h ough he p og am. The e o e, he numbe o pa ien s alida ed o he p og am is exclusi ely dependen on he numbe o medical e e als. In o de o o e come his ba ie , his p og am also has he objec i e o aise awa eness amongs heal h p o essionals abou PR, i s bene i s, he a ge popula ion, e e als, and he a ailable p og am. Ano he conc e e limi a ion is he op ion o exe cise aining. Acco ding o he Po uguese o ien a ion o he Di ec o a e-Gene al o Heal h o PR [ 56 ], g ounded by ATS/ERS guidelines [ 10 ], he amewo k ecommended o he in ensi y o he endu ance aining (60% o maximal wo k a e on he ca diopulmona y exe cise es ing o 80% o he a e age speed on 6MWT) is no possible o implemen in con ex o he eabili AR p og am. Ne e heless, he exe cise in ensi y is selec ed by he pe cei ed dyspnea and a igue on he modi ied Bo g scale [ 10 , 18 ], which is widely used ool o sel -moni o ing and sel - egula ing exe cise o pa ien s du ing he unsupe ised sessions and ecommended in he LWWCOPD p og am. The implemen a ion o he eabili AR p og am ep esen s he ideal oppo uni y o explo e u u e esea ch o ad ance e idence-based in home-based PR. One p oposal is o assess he maximal olun a y muscles con ac ion wi h handheld dynamome e o explo e he cha ac e iza ion o he muscula s eng h and i s sho - and long- e m e ec s wi h home-based PR in pa ien s wi h CRD. The assessmen o his ou come is impo an since i is se ed as a p edic o o mo ali y [ 3 ]. Ano he p oposal is o assess he long- e m e ec s in beha io change o physical ac i i y wi h he gold s anda d measu e using an accele ome e . 4. Conclusions We expec ha he eabili AR p og am will enhance he pa ien s’ access o PR in Po ugal and p o ide an e idence-based insigh in o he posi i e impac on symp oms, emo ional s a us, unc ional capaci y, and physical ac i i y in pa ien s wi h CRD. Au ho Con ibu ions: Concep ualiza ion, S.B., S.M.-A., C.E. and C.C.; me hodology, S.B., R.V., I.P., R.C. (Rosa Can an e), R.C. (Rica do Coxo), R.F., J.C., C.E. and C.C.; alida ion, S.B., J.C., S.M.-A., S.D.L., C.E. and C.C.; o mal analysis, S.B., R.V., C.E. and C.C.; in es iga ion, S.B., R.V., I.P., R.C. (Rosa Can an e), R.C. (Rica do Coxo), R.F., S.M.-A., S.D.-L., J.C., C.E. and C.C.; esou ces, S.M.-A., S.D.-L., C.E. and C.C.; da a cu a ion, S.B., R.V., C.E. and C.C.; w i ing—o iginal d a p epa a ion, S.B., R.V. and C.C.; w i ing— e iew and edi ing, S.B., R.V., I.P., R.C. (Rosa Can an e), R.C. (Rica do Coxo), R.F., S.M.-A., S.D.-L., J.C., C.E. and C.C.; isualiza ion, S.B., R.V. and C.C.; supe ision, C.E. and C.C.; p ojec adminis a ion, C.C. All au ho s ha e ead and ag eed o he published e sion o he manusc ip . Funding: This esea ch ecei ed no ex e nal unding. Ins i u ional Re iew Boa d S a emen : The s udy was conduc ed acco ding o he guidelines o he Decla a ion o Helsinki. In o med Consen S a emen : In o med consen is ob ained om all subjec s in ol ed in he p og am . Da a A ailabili y S a emen : None. Con lic s o In e es : The au ho s decla e no con lic o in e es . Re e ences 1. Wo ld Heal h O ganiza ion. Ch onic Respi a o y Diseases. A ailable online: h ps://www.who.in /heal h- opics/ch onic- espi a o y-diseases (accessed on 21 Sep embe 2020). 2. Machado, A.; Ma ques, A.; Bu in, C. Ex a-pulmona y mani es a ions o COPD and he ole o pulmona y ehabili a ion: A symp om-cen e ed app oach. Expe Re . Respi . Med. 2021,15, 131–142. [C ossRe ]