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.
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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://
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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 ]