In e na ional Jou nal o
En i onmen al Resea ch
and Public Heal h
A icle
Immedia e E ec s o a Tele ehabili a ion P og am Based on
Ae obic Exe cise in Women wi h Fib omyalgia
Ignacio He nando-Ga ijo 1, Luis Ceballos-Lai a 1, Ma ía Te esa Mingo-Gómez 1, Rica do Med ano-de-la-Fuen e 1,
Elena Es ébanez-de-Miguel 2, Ma ía Na i idad Ma ínez-Pé ez 3and Sand a Jiménez-del-Ba io 1,*


Ci a ion: He nando-Ga ijo, I.;
Ceballos-Lai a, L.; Mingo-Gómez,
M.T.; Med ano-de-la-Fuen e, R.;
Es ébanez-de-Miguel, E.;
Ma ínez-Pé ez, M.N.;
Jiménez-del-Ba io, S. Immedia e
E ec s o a Tele ehabili a ion
P og am Based on Ae obic Exe cise in
Women wi h Fib omyalgia. In . J.
En i on. Res. Public Heal h 2021,18,
2075. h ps://doi.o g/10.3390/
ije ph18042075
Academic Edi o : Dae Yun Seo
Recei ed: 8 Janua y 2021
Accep ed: 15 Feb ua y 2021
Published: 20 Feb ua y 2021
Publishe ’s No e: MDPI s ays neu al
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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
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A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
1Depa men o Su ge y, Oph halmology and Physio he apy, Facul y o Heal h Sciences,
Uni e si y o Valladolid, 42004 So ia, Spain; [email p o ec ed] (I.H.-G.); [email p o ec ed] (L.C.-L.);
mingo@ci .u a.es (M.T.M.-G.); [email p o ec ed] (R.M.-d.-l.-F.)
2Depa men o Physia is and Nu se y, Facul y o Heal h Science, Uni e si y o Za agoza,
50009 Za agoza, Spain; eles eba@uniza .es
3Physical and Rehabili a ion Depa men , San a Ba ba a Clinical Hospi al, 42004 So ia, Spain;
[email p o ec ed]
*Co espondence: [email p o ec ed]; Tel.: +34-975129100 (ex . 9166)
Abs ac :
Backg ound: We analyzed he immedia e e ec s o a Tele ehabili a ion P og am (TP)
based on ae obic exe cise in women wi h ib omyalgia (FM) synd ome du ing he lockdown decla ed
in Spain due o he COVID-19 pandemic. Me hods: A single-blind andomized con olled ial was
designed. Thi y- ou women wi h FM we e andomized in o wo g oups: TP g oup and Con ol
g oup. The in e en ion las ed 15 weeks, wi h 2 sessions pe week. The TP based on ae obic exe cise
was guided by ideo and he in ensi y o each session was moni o ed using he Bo g scale. Pain in-
ensi y (Visual Analogue Scale), mechanical pain sensi i i y (algome e ), numbe o ende poin s,
FM impac (Re ised Fib omyalgia Impac Ques ionnai e), pain ca as ophizing (Pain Ca as ophiz-
ing Scale), physiological dis ess (Hospi al Anxie y and Dep ession Scale),
uppe (A m Cu l Tes )
and lowe -limb physical unc ion (6-min Walk Tes ) we e measu ed a baseline and a e he in e en-
ion. Resul s: The TP g oup imp o ed pain in ensi y (p= 0.022), mechanical pain sensi i i y (p< 0.05),
and psychological dis ess (p= 0.005), compa ed o he Con ol g oup. The Con ol g oup showed no
s a is ically signi ican changes in any a iable (p> 0.05). Conclusions: A TP based on ae obic exe cise
achie ed imp o emen s on pain in ensi y, mechanical pain sensi i i y, and psychological dis ess
compa ed o a Con ol g oup du ing he lockdown decla ed in Spain due o COVID-19 pandemic.
Keywo ds: ib omyalgia; ch onic pain; exe cise; ehabili a ion; ele ehabili a ion
1. In oduc ion
Fib omyalgia (FM) is a ch onic diso de cha ac e ized by pe sis en widesp ead pain
and commonly associa ed wi h psychological dis ess, pain ca as ophizing and lowe
le els o physical unc ion among o he symp oms [
1
–
3
]. The FM wo ldwide p e alence
has been es ima ed in 2.1% and has shown o be highe among women, a a a e o 4:1 [
4
].
The Wo ld Heal h O ganiza ion decla ed in Ma ch 2020 he COVID-19 as a global
pandemic [
5
]. Mos coun ies ca ied ou measu es such as lockdown and es ic ions o
p e en he sp ead o COVID-19 and educe he in ec ion isk. These es ic ions ha e
esul ed in nega i e e ec s by limi ing he pa icipa ion in no mal daily li ing, social
and physical ac i i ies, and he access o many o ms o exe cise [
6
,
7
]. The di ec and
indi ec consequences de i ed om he pandemic si ua ion ha e a ec ed he heal h s a us
o pa ien s wi h ch onic diseases [
8
]. Pa ien s wi h FM ha e epo ed an inc ease in pain
in ensi y, pain ca as ophizing, physiological dis ess, and seden a y li es yles a ec ing
nega i ely o he quali y o li e and social aspec o hese pa ien s [3,9–11].
Clinical guidelines ecommend he use o conse a i e non-pha macological he apies
as a i s -line in e en ion o pa ien s wi h FM [
12
,
13
]. The ae obic exe cise is one o he
In . J. En i on. Res. Public Heal h 2021,18, 2075. h ps://doi.o g/10.3390/ije ph18042075 h ps://www.mdpi.com/jou nal/ije ph
In . J. En i on. Res. Public Heal h 2021,18, 2075 2 o 12
mos accep ed modali ies. Recen s udies showed ha indi idualized low-in ensi y ae obic
exe cise was well- ole a ed by pa ien s wi h FM [
14
–
16
]. These s udies achie ed posi i e
e ec s on pain in ensi y, FM impac , hype algesia, physical unc ion, ca as ophizing,
and psychological dis ess [
14
–
16
], wi hou majo ad e se e en s [
14
]. In addi ion, ae obic
exe cise showed lowe cos s and la ge posi i e e ec s compa ed o usual ca e [17].
Gi en he high p o essional and economic equi emen s in he heal h ca e sys em
du ing he COVID-19 pandemic, he design o he apeu ic s a egies wi hou he isk
o i al in ec ion has become necessa y, and ele ehabili a ion has been p oposed as a
easible me hod [
18
]. Tele ehabili a ion has been de eloped in he las yea s and implies
he subs i u ion o adi ional ace- o- ace app oaches by elema ic p ocedu es, using ele-
phone, ideo, and compu e echnologies [
19
]. Tele ehabili a ion allows guide some
he apies o main ain social dis ance, while keeping he he apis –pa ien communica ion
and moni o ing [20–22].
Ou hypo hesis is ha a ele ehabili a ion p og am (TP) based on ae obic exe cise
could imp o e he main FM symp oms in pa ien s wi h FM.
The e o e, he pu pose o his s udy was o analyze he immedia e e ec s on pain
in ensi y, mechanical pain sensi i i y, FM impac , pain ca as ophizing, psychological
dis ess, and physical unc ion o a TP based on ae obic exe cise in pa ien s wi h FM du ing
he pe iod o mobili y es ic ions imposed by he COVID-19 pandemic.
2. Ma e ial and Me hods
2.1. S udy Design
We conduc ed a single-blind andomized con olled ial o analyze he e ec s o a TP
based on ae obic exe cise in pa ien s wi h FM. This s udy was ca ied ou a he Facul y o
Heal h Sciences o he Uni e si y o Valladolid om Ma ch o June 2020 (lockdown pe iod
in Spain) and was de eloped acco ding o CONSORT guidelines. The e hical app o al was
ob ained om he Resea ch E hics Commi ee o Valladolid Es e (19-410) and he s udy
was egis e ed a clinical ials.go (NCT04340674).
2.2. Pa icipan s
The pa icipan s we e e e ed by a heuma ologis om Feb ua y o Ma ch 2020.
Thi y-se en pa ien s diagnosed wi h FM (mean yea s since diagnosis
±
SD: 10.54
±
7.4)
we e sc eened o which 37 women aged om 30 o 75 (mean
±
SD: 53.44
±
8.8) yea s,
pa icipa ed in he s udy.
The inclusion c i e ia we e: women diagnosed wi h FM by a heuma ologis acco ding
o he la es diagnos ic c i e ia o he Ame ican College o Rheuma ology [
23
], aged om
30 o 75 yea s, and ha ing access o in e ne wi h any ype o digi al de ice.
The exclusion c i e ia we e: p esence o o he sys emic, soma ic, o psychia ic dis-
eases, p egnancy o lac a ion, p e ious physio he apy ea men s, o modi ica ions in
pha macological ea men s du ing he s udy o in he las 3 mon hs be o e he in e en-
ion, exe cise con aindica ions, o inabili y o communica e wi h examine s.
2.3. Sample Size
The calcula ion o he sample size was pe o med based on he p ima y dependen
a iable (pain in ensi y). Se en een pa ien s pe g oup we e es ima ed assuming a s anda d
de ia ion o 1.9 p e iously epo ed in a pilo s udy in pa ien s wi h FM and a be ween-
g oup mean di e ence o 2 cm in he Visual Analogue Scale (VAS), which is conside ed
as he minimum ele an change, es ablishing an
α
e o o 5%, a
β
e o o 20%, and a
ollow-up loss a e o 15%. The so wa e used o he sample size calcula ion was Mini ab
®
p og am e sion 13.0.
2.4. Randomiza ion
All he pa icipan s ha me he inclusion and exclusion c i e ia we e andomly
alloca ed o he TP g oup o o he Con ol g oup. The alloca ion ( a io 1:1) was pe o med
In . J. En i on. Res. Public Heal h 2021,18, 2075 3 o 12
by an independen esea che who did no pa icipa e in he da a acquisi ion o s a is ical
analysis, using he G aphPad compu e so wa e 2018 (G aphPad So wa e, San Diego,
CA, USA) [24].
2.5. In e en ions
The TP g oup ecei ed 15 weeks o a ele ehabili a ion ae obic exe cise p og am.
The Con ol g oup ecei ed no addi ional in e en ions. Bo h he TP g oup and he Con ol
g oup we e asked o main ain he same medical p esc ip ion du ing he s udy.
The in e en ion was pe o med by an expe ienced physio he apis wi h mo e han
4 yea s o clinical expe ience in he apeu ic exe cise o ch onic diseases, who was blinded
o he measu emen s.
The TP g oup comple ed 30 sessions o exe cise, du ing 15 weeks, wi h 2 sessions pe
week [
20
,
25
]. Tele ehabili a ion sessions we e based on low-impac hy hmic mo emen s,
guided by ideo, acco ding o he p o ocol o Schach e e al. [
26
]. The TP was designed
acco ding o Ame ican Pain Socie y guidelines on FM, ha ecommended mode a ely
in ense ae obic exe cise 2–3 imes pe week [
27
] and included 3 pa s: wa m-up, cen al
pa , and cool-down. Each session las ed 50 min.
The wa m-up consis ed o join mobili y exe cises and ac i e s e ching. In he cen al
pa , he ae obic exe cises we e based on low-impac hy hmic mo emen s guided by ideo.
The epe i ion a e de e mines he in ensi y o he exe cises: 10, 15, 20, o 25 epe i ions pe
minu e. The pa ien s could wa ch he ou in ensi ies o each exe cise pe o med by he
he apis on ideo. The i s wo sessions we e supe ised be o e ele ehabili a ion sessions
o ensu e ha he pa ien s pe o med he exe cises in a co ec and sa e way and allowed o
es ablish he in ensi y o he p o ocol a he beginning o he in e en ion. The exe cise in ensi y
o each ele ehabili a ion session was indi idually adjus ed by he pa icipan s’ Modi ied Bo g
pe cei ed exe ion epo ed in p e ious session. The Modi ied Bo g Scale anges om 0 o 10
poin s wi h highe sco es ep esen ing highe physical exe ion [
28
] and has shown o be a alid
ool o de e mine in ensi y in FM pa ien s [
29
]. The exe cise in ensi y was inc eased i he Bo g
a e was less han 4 and in ensi y was dec eased i he Bo g a e was mo e han 7, acco ding
o he p o ocol desc ibed by Du u u k e al. [
30
]. The cool-down pa was based on s a is
s e ching o he majo muscles (3 se s o 30 s) and b ea hing echniques. The physio he apis ,
who pe o med he in e en ion, adap ed and con olled all he exe cises o a oid any ad e se
e en and o ensu e pa ien s’ sa e y.
Pa icipan s o bo h g oups we e called by ideo call, once a week. The pa icipan s o
he TP g oup we e called o con ol and indi idualize he exe cises. The pa icipan s o he
Con ol g oup we e con ac ed o ensu e ha hey main ained he same condi ions du ing
he s udy.
The ea men adhe ence was egis e ed using an online a endance eco d Google
Fo ms so wa e (Google LLC, Menlo Pa k, CA, USA).
2.6. Ou come Measu es
The measu emen s we e pe o med he p e ious week be o e he lockdown, by wo
physio he apis s blinded o he g oup assignmen . Clinical and demog aphic in o ma ion
including age, sex, heigh , weigh , body mass index, and medica ion in ake we e eco ded
a baseline. All he ou come measu es we e assessed a baseline and a e he in e en ion.
P ima y ou come
The main ou come measu e was pain in ensi y. Pain in ensi y was egis e ed using
he 10-cm VAS, in which 0 ep esen ed “no pain” and 10 ep esen ed “ he mos in ense
pain imaginable.” This scale showed excellen eliabili y in ch onic pain subjec s, wi h an
In aclass Co ela ion Coe icien (ICC) o 0.97–0.99 [31,32].
Seconda y ou comes
Mechanical pain sensi i i y was e alua ed wi h an analogical p essu e algome e
(Psym ec, FPK 20, Wagne Ins umen s, G eenwich, USA). The 18 ende poin s desc ibed
in he 1990 ACR c i e ia we e assessed [33]. The ende poin s we e igh and le occipu ,
In . J. En i on. Res. Public Heal h 2021,18, 2075 4 o 12
low ce ical, apezius, sup aspina us, second ib, la e al epicondyle, glu eal, g ea e
ochan e , and knee. The mechanical pain sensi i i y h eshold was measu ed wi h he
algome e applying inc easing p essu e on each ende poin whe e he sense o p essu e
change o pain was egis e ed as he pain h eshold. P essu e was inc eased a a a e
o 1 kg/s. Pa icipan s we e ins uc ed o say “s op” when he p essu e became o clea
sensa ion o pain. The numbe o ende poin s and he algome e sco e we e analyzed a e
he measu emen s. A ende poin was conside ed i he h eshold was
≤
4 kg/cm
2
[
33
].
The algome e sco e was calcula ed as he sum o he pain-p essu e alues ob ained o
each ende poin . Mechanical pain sensi i i y measu ed h ough algome y has shown
good o excellen eliabili y in di e en body egions (ICC = 0.82–0.97) [34,35].
FM impac was measu ed using he Spanish e sion o he Re ised Fib omyalgia
Impac Ques ionnai e (FIQ-R). This ques ionnai e consis s o 21 ques ions based on an
11-poin nume ic a ing scale o 0 o 10. The sco es ange om 0 o 100, wi h highe
sco es ep esen ing highe FM impac . The eliabili y o he ques ionnai e has shown o be
excellen (ICC = 0.81) [36].
The Spanish e sion o he Pain Ca as ophizing Scale (PCS) was used o measu e
ca as ophizing cogni ions ela ed o pain. This scale assesses he dimensions o umina ion,
magni ica ion, and helplessness and consis s o 14 i ems, wi h each i em a ed om 0 (no a
all) o 4 (all he ime). The o al sco e anged om 0 o 52 poin s, and highe alues show
highe pain ca as ophizing. To al sco e and dimensions we e egis e ed. The Spanish
e sion o PCS has shown good es – e es eliabili y in FM pa ien s (ICC = 0.84) [37].
Psychological dis ess was measu ed using he Hospi al Anxie y and Dep ession
Scale (HADS). The scale includes an anxie y subscale (HADS-A) and a dep ession subscale
(HADS-D), wi h 7 i ems in o each subscale. Subscale sco es ange om 0 o 21, wi h highe
sco es ep esen ing highe anxie y o dep ession le els. To al sco e and subscales we e
egis e ed. The HADS has shown good es – e es eliabili y (ICC = 0.84–0.94) [38,39].
The uppe and lowe limbs’ physical unc ion was measu ed wi h he 6-min Walk
Tes (6MWT) and wi h he A m Cu l Tes (ACT), espec i ely. The 6MWT measu es he
maximum dis ance in me e s ha an indi idual is able o walk, as as as possible, du ing
he pe iod o 6 min. In he ACT es , he pa ien s, sea ed on a chai wi h back es and
holding a dumbbell (2.3 kg) wi h he elbow ex ended, had o lex and ex end he elbow
as many imes as possible in 30 s [
40
]. Bo h es s ha e shown excellen eliabili y in FM
pa ien s (6MWT ICC: 0.91–0.98; ACT ICC: 0.81–0.86) [41,42].
2.7. S a is ical Analysis
An assesso blinded o he ea men alloca ion conduc ed he s a is ical analysis using
SPSS so wa e, e sion 24.0. The s a is ical analysis was conduc ed acco ding o in en ion-
o- ea (ITT). Mean and s anda d de ia ions we e calcula ed o quan i a i e a iables.
F equencies and pe cen ages we e calcula ed o quali a i e a iables. The Shapi o-Wilk
es was used o assess he no mal dis ibu ion o quan i a i e a iables. Be ween-g oup
compa isons o clinical and demog aphic a iables we e analyzed using he S uden
´
s - es
o no mally dis ibu ed da a o he Mann–Whi ney U es o non-no mally dis ibu ed
da a. Chi-squa e es (X2) was used o be ween-g oup compa ison o nominal a iables.
A wo-way ANOVA was used o analyze he di e ences in ou comes wi h ime
(baseline and pos in e en ion) as he wi hin-subjec s ac o and g oup (TP g oup and
Con ol g oup). A p- alue < 0.05 was conside ed s a is ically signi ican . The e ec size
(Cohen’s d) was also calcula ed, o es ima e he magni ude o he di e ences wi hin and
be ween g oups. The magni ude o di e ence was classi ied as small i he alue o Cohen’s
d anged om 0.2 o 0.5, as mode a e i i anged om 0.5 o 0.8 o , as la ge i Cohen’s
d alue was g ea e han 0.8.
3. Resul s
Thi y-se en pa ien s diagnosed wi h FM we e sc eened. Th ee pa ien s we e ex-
cluded: 2 pa ien s did no mee he inclusion c i e ia and 1 pa ien declined o pa icipa e
In . J. En i on. Res. Public Heal h 2021,18, 2075 5 o 12
o pe sonal easons. Thi y- ou emale pa ien s ha me he eligibili y c i e ia signed
he in o med consen and we e andomized in o he TP g oup (n= 17) o he Con ol
g oup (n= 17). Six pa ien s ailed o comple e he s udy: h ee pa ien s in he TP g oup
and h ee pa ien s in he Con ol g oup. The lowcha diag am o he ec ui men and
ollow-up o pa icipan s is shown in Figu e 1. Demog aphic and medica ion in ake a
baseline a e shown in Table 1. No s a is ically signi ican di e ences we e ound be ween
bo h g oups a baseline (p> 0.05). Adhe ence o he TP g oup o e he 10 weeks was high,
a e aging 89.9%.
A e he in e en ion, a wo-way ANOVA showed signi ican G oup by Time in e ac-
ions o pain in ensi y (F = 5.99; p= 0.021), mechanical pain sensi i i y (Algome e sco e:
F = 10.67; p= 0.003; ac i e poin s: F = 7.90; p= 0.009), and psychological dis ess (F = 12.03;
p= 0.002). The TP g oup showed a g ea e dec ease in pain in ensi y (
∆
1.53 (0.04 o 3.03)
and in psychological dis ess (
∆
9.54 (3.09 o 15.99) and a g ea e inc ease in mechanical
pain sensi i i y (algome e sco e:
∆−
14.06 (
−
26.20 o
−
1.92); ende poin s:
∆
2.65 (0.18 o
5.11) han he Con ol g oup. The esul s achie ed o hese a iables in he PT g oup
showed a la ge e ec size (>0.8). The e we e no s a is ically signi ican di e ences be ween
bo h g oups on FM impac , pain ca as ophizing, and physical unc ion (p> 0.05).
Rega ding wi hin-g oup change sco es, he PT g oup showed a s a is ically signi ican
imp o emen in all he a iables (p< 0.05) excep in he umina ion PCS subscale (p= 0.078)
and in he 6MWT (p= 0.051). No wi hin-g oups di e ences we e ound in any a iable in
he Con ol g oup (p> 0.05). Table 2p o ides be o e and a e in e en ion da a, wi hin-
and be ween-g oups di e ences as well as he e ec size o all he dependen a iables.
In . J. En i on. Res. Public Heal h 2021, 18, x FOR PEER REVIEW 5 o 12
be ween g oups. The magni ude o di e ence was classi ied as small i he alue o Co-
hen’s d anged om 0.2 o 0.5, as mode a e i i anged om 0.5 o 0.8 o , as la ge i Cohen’s
d alue was g ea e han 0.8.
3. Resul s
Thi y-se en pa ien s diagnosed wi h FM we e sc eened. Th ee pa ien s we e ex-
cluded: 2 pa ien s did no mee he inclusion c i e ia and 1 pa ien declined o pa icipa e
o pe sonal easons. Thi y- ou emale pa ien s ha me he eligibili y c i e ia signed he
in o med consen and we e andomized in o he TP g oup (n = 17) o he Con ol g oup
(n = 17). Six pa ien s ailed o comple e he s udy: h ee pa ien s in he TP g oup and h ee
pa ien s in he Con ol g oup. The lowcha diag am o he ec ui men and ollow-up o
pa icipan s is shown in Figu e 1. Demog aphic and medica ion in ake a baseline a e
shown in Table 1. No s a is ically signi ican di e ences we e ound be ween bo h g oups
a baseline (p > 0.05). Adhe ence o he TP g oup o e he 10 weeks was high, a e aging
89.9%.
Figu e 1. Flowcha diag am.
Figu e 1. Flowcha diag am.

In . J. En i on. Res. Public Heal h 2021,18, 2075 6 o 12
Table 1. Baseline cha ac e is ics o he s udy popula ion.
TP G oup
Mean ( ±SD)
Con ol G oup
Mean ( ±SD) Signi icance
Age (yea s) 51.81 ±9.05 55.06 ±8.51 0.304 a
Heigh (cm) 158.63 ±6.29 161.81 ±5.13 0.191 b
Weigh (kg) 68.19 ±16.88 68.13 ±15.10 0.836 b
BMI (kg/cm2)27.25 ±7.30 25.93 ±5.27 0.598 b
Medica ion n(%) 17 (100) 17 (100) 0.224 c
Anxioly ics n(%) 9 (53) 7 (41)
An idep essan s n(%) 9 (53) 9 (53)
An i-in lamma o y n(%) 14 (82) 8 (47)
Analgesic n(%) 11 (65) 12 (71)
Muscle elaxan n(%) 4 (24) 2 (12)
a
: S uden
´
s - es ;
b
: Mann–Whi ney U;
c
: Chi-squa e. Values o quan i a i e da a a e exp essed in mean and s anda d de ia ion,
and alues o medica ion a e exp essed as pe cen ages (%) and equencies (n).
In . J. En i on. Res. Public Heal h 2021,18, 2075 7 o 12
Table 2. P ima y and seconda y ou comes a baseline and a e in e en ion as well as wi hin-g oup mean sco es.
Baseline
Mean ±SD (95% CI)
Pos in e en ion
Mean ±SD (95% CI)
Wi hin-G oup Changes
p-Values
Wi hin-G oup
E ec Sizes
(Cohen’s d)
Be ween-G oups
p-Value
Be ween-G oups E ec Sizes
(Cohen’s d)
VAS (0–10)
TP g oup 7.08 ±1.45 (6.38 o 7.78) 4.92 ±2.00 (3.85 o 6.00) 2.15 (1.37, 2.94) <0.001 −1.2 F = 5.99
0.021 0.8
Con ol g oup 7.29 ±1.07 (6.62 o 7.96) 6.46 ±1.92 (5.42 o 7.50) 0.82 (−0.3, 1.68) 0.058 −0.5
Algome e sco e (kg/cm2)
TP g oup 45.42 ±12.56 (37.92 o 52.92) 56.85 ±15.28 (48.43 o 65.28) −11.43 (−18.38, −4.48) 0.004 0.8 F = 10.67
0.003 0.9
Con ol g oup 45.20 ±14.68 (37.49 o 52.98) 42.79 ±15.32 (34.05 o 51.53) 2.40 (−3.48, 8.29) 0.391 −0.1
Tende poin s
TP g oup 16.00 ±3.38 (14.42 o 17.57) 14.13 ±4.12 (12.42 o 15.84) 1.86 (0.56, 3.17) 0.008 −0.5 F = 7.90
0.009 0.8
Con ol g oup 16.50 ±2.47 (14.86 o 18.13) 16.78 ±1.84 (15.01 o 18.55) −0.28 (−1.25,0.68) 0.537 0.1
FIQ-R
TP g oup 59.44 ±9.04 (52.14 o 66.74) 44.00 ±15.21 (34.10 o 53.91) 15.43 (7.81, 23.05) 0.001 −1.2 F = 1.36
0.254 0.1
Con ol g oup 55.36 ±16.46 (48.06 o 62.66) 46.90 ±20.47 (36.99 o 56.81) 8.45 (−1.99, 18.90) 0.104 −0.4
PCS
TP g oup 24.8 ±12.0 (18.27 o 29.47) 17.6 ±12.4 (14.19 o 28.17) 7.00 (1.19, 12.80) 0.022 −0.6 F = 0.415
0.525 0.4
Con ol g oup 24.10 ±10.8 (15.72 o 28.40) 23.5 ±14.0 (13.45 o 27.70) 1.07 (−4.54, 6.68) 0.687 0.0
Rumina ion
TP g oup 7.2 ±3.8 (5.32 o 9.53) 5.1 ±4.7 (2.45 o 7.69) 2.34 (−0.29, 5.01) 0.078 −0.5 F = 1.91
0.169 0.4
Con ol g oup 7.2 ±3.6 (5.15 o 9.09) 6.9 ±4.9 (4.42 o 9.32) 0.25 (−1.65, 2.15) 0.783 0.0
Helplessness
TP g oup 12.1 ±6.3 (8.80 o 14.91) 8.9 ±6.1 (5.19 o 12.65) 2.92 (0.46, 5.39) 0.023 −0.5 F = 0.430
0.518 0.2
Con ol g oup 12.4 ±5.2 (9.07 o 14.79) 10.2 ±7.4 (6.69 o 13.67) 1.75 (−1.13, 4.63) 0.215 −0.3
Magni ica ion
TP g oup 5.5 ±2.9 (3.81 o 6.75) 3.6 ±2.4 (2.97 o 5.07) 1.71 (0.38, 3.04) 0.015 −0.7 F = 2.05
0.163 0.1
Con ol g oup 4.4 ±2.5 (3.12 o 5.87) 3.9 ±3.0 (2.53 o 5.34) 0.56 (−0.55, 1.67) 0.300 −0.1
HADS
TP g oup 20.52 ±6.83 (16.76 o 24.29) 11.70 ±8.74 (7.21 o 16.19) 8.82 (3.33, 14.30) 0.004 −1.1 F=12.03
0.002 1.0
Con ol g oup 20.43 ±8.37 (16.55 o 24.32) 21.25 ±9.42 (16.62 o 25.88) −0.81 (−2.50, 0.87) 0.321 0.0
In . J. En i on. Res. Public Heal h 2021,18, 2075 8 o 12
Table 2. Con .
Baseline
Mean ±SD (95% CI)
Pos in e en ion
Mean ±SD (95% CI)
Wi hin-G oup Changes
p-Values
Wi hin-G oup
E ec Sizes
(Cohen’s d)
Be ween-G oups
p-Value
Be ween-G oups E ec Sizes
(Cohen’s d)
HADS-A
TP g oup 10.88 ±3.38 (9.02 o 12.73) 6.29 ±5.13 (3.86 o 8.72) 4.58 (1.69, 7.47) 0.004 −1.0 F = 10.25
0.003 0.9
Con ol g oup 10.81 ±4.10 (8.90 o 12.72) 11.00 ±4.66 (8.49 o 13.05) −0.18 (−1.27, 0.89) 0.718 0.0
HADS-D
TP g oup 9.64 ±4.16 (7.49 o 11.81) 5.41 ±4.13 (3.09 o 7.72) 4.23 (1.51, 6.95) 0.005 −1.0 F = 2.97
0.001 1.0
Con ol g oup 9.62 ±4.58 (7.34 o 11.85) 10.31 ±5.19 (7.92 o 12.69) −0.68 (−1.65, 0.27) 0.151 0.1
6MWT
TP g oup 403.57 ±107.13 (327.90 o 480.14) 434.72 ±73.78 (367.94 o 501.50) −30.70 (14.13, −61.50) 0.051 0.3 F = 1.54
0.225 −0.2
Con ol g oup 407.01 ±137.09 (326.60 o 473.35) 411.72 ±145.83 (347.37 o 476.07) −11.71 (−26.16, 2.73) 0.104 0.0
ACT
TP g oup 9.60 ±4.31 (6.28 o 12.01) 11.38 ±4.27 (8.57 o 14.19) −2.23 (−3.65, −0.81) 0.005 0.4 F = 3.98
0.056 −0.2
Con ol g oup 10.06 ±5.56 (7.39 o 12.73) 10.33 ±5.42 (7.72 o 12.94) −0.26 (−1.81, 1.27) 0.717 0.0
VAS: Visual Analogue Scale; FIQ-R: Fib omyalgia Impac Ques ionnai e; PCS: Pain Ca as ophizing Scale; HADS: Hospi al Anxie y and Dep ession Scale; HADS-A: Hospi al Anxie y and Dep ession Scale–Anxie y
Subscale: HADS-D: Hospi al Anxie y and Dep ession Scale–Dep ession Subscale; 6MWT: 6-min Walk Tes ; ACT: A m Cu l Tes .
In . J. En i on. Res. Public Heal h 2021,18, 2075 9 o 12
4. Discussion
This andomized con olled clinical ial is he i s s udy o in es iga e he e ec s o a
TP based on ae obic exe cise in women wi h FM du ing he lockdown caused by COVID-19
pandemic. The esul s epo ed in his s udy showed ha he TP g oup achie ed s a is ically
signi ican imp o emen s on pain in ensi y, mechanical pain sensi i i y, and psychological
dis ess compa ed o a Con ol g oup.
Pain in ensi y, mechanical pain sensi i i y, and psychological dis ess imp o ed a e
TP in e en ion. The change achie ed on pain in ensi y was supe io o he MCID (Minimal
Clinically Impo an Di e ence) desc ibed o pa ien s wi h ch onic pain [
43
]. The change
achie ed on psychological dis ess was s a is ically signi ican and supe io o he MCID
s a ed o pa ien s wi h ch onic disease [
44
]. Howe e , he mean alue a he end o he
ea men was highe han 8 poin s, conside ed he ma ked sco e o he diagnosis o
psychological dis ess [
45
]. These esul s a e simila o p e ious s udies showing ha
ae obic exe cise educes pain in ensi y, mechanical pain sensi i i y, and psychological
dis ess [
16
,
46
–
49
], howe e , in his clinical ial, we achie ed imp o emen s wi h a TP
wi hou ace- o- ace sessions.
Regula exe cise has shown o modi y he le els o neu o ansmi e s, neu omodula-
o s, and he hypo halamic–pi ui a y unc ion [
50
,
51
]. The changes in hese elemen s a e
ela ed o imp o emen s on pain, s ess, anxie y, and dep ession among o he s in pa ien s
wi h ch onic pain [
52
,
53
]. In his way, he analgesic e ec o exe cise has shown o be ela ed
o highe le els o endo phins [
54
]. Thus, he imp o emen s on pain, mechanical pain
sensi i i y, and psychological dis ess achie ed in ou s udy could be ela ed o he inc ease
in neu o ansmi e s’ le els, especially, endo phins, elease by he hypo halamus [
50
,
51
,
54
].
The TP g oup showed imp o emen s on FM impac , pain ca as ophizing, and uppe
limb physical unc ion. Howe e , hese changes we e no enough o epo s a is ically
signi ican di e ences be ween g oups. The esul s o his s udy a e in acco dance wi h p e-
ious s udies ha ound no di e ences compa ing he apeu ic exe cise o usual
ca e [25,55]
.
The in e en ion applied o he TP g oup could be an insu icien s imulus o imp o e
hese a iables. Conce ning pain ca as ophizing and FM impac , he ae obic exe cise in
isola ion could no be able o modi y he belie s and cogni ions abou pain. O he s udies
epo ed ha he addi ion o pain neu ophysiology educa ion o exe cise he apy seems
o epo be e bene i s on pain ca as ophizing and FM impac han exe cise he apy in
isola ion [56–58].
Rega ding he physical unc ion, only he TP g oup showed a s a is ically signi ican
imp o emen in he uppe limb physical unc ion. No wi hin- o be ween-g oups di e -
ences we e ound o he es o physical unc ion a iables. A ecen sys ema ic e iew
epo ed ha ae obic exe cise imp o es physical unc ion [
14
], howe e , i is impo an o
men ion ha he cu en clinical ial was pe o med du ing he lockdown si ua ion, so he
pa ien s we e no allowed o go ou . The social and mobili y es ic ions du ing he s udy
pe iod may explain he lack o imp o emen s achie ed in hese a iables.
F om a clinical pe spec i e, his s udy p o ides e idence sugges ing ha a TP in-
e en ion based on ae obic exe cise could be an e ec i e s a egy in FM pa ien s, in he
excep ional si ua ion caused by he COVID-19 pandemic. TP in e en ion could imp o e
FM symp oms in a sa e way, wi hou ad e se e en s, and show high adhe ence le el.
The indi idualized supe ision pe o med by he physio he apis allowed moni o ing he
ype o exe cises, he in ensi y o he sessions, and he s a us o he pa ien s, which seems
o be necessa y o achie e a high adhe ence le el and heal hy habi s in pa ien s wi h FM.
The p esen s udy has po en ial limi a ions. Fi s , men we e no included in his s udy,
so esul s canno be gene alized o he en i e popula ion. Second, he in e en ion was
no compa ed wi h o he expe imen al in e en ions, such a supe ised exe cise p og am.
Thi d, he educed small sample size conside ed in he s udy made i di icul o achie e
be ween-g oup changes in some a iables. Finally, he e was a lack o ollow-up analysis,
o his eason, he long- e m e ec s o he s udy in e en ion we e no epo ed.