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Table 4 Included RCTs with diagnostic-inclusion criteria with PEM as an optional criterion (CFS patients)

From: The evidence base for physiotherapy in myalgic encephalomyelitis/chronic fatigue syndrome when considering post-exertional malaise: a systematic review and narrative synthesis

Author, Year

Country

Intervention (I)

Comparison (C)

Participants details (I/C)

Number allocated (N),

Mean age (year)

Gender (% female)

Diagnostic criteria

Duration

Session duration

Frequency

No. of sessions (ss),

period (# weeks)

Outcome measure momentsa (weeks)

Main outcome measures

1 Primary

2 Secondary

Adverse events

Treatment withdrawn

(I/C)

ITTb

Results (benefits), compared to controlc

Concl.—Authors own conclusion

Kos et al. 2015 [64]

Belgium

Activity pacing self-management (APSM)

Relaxation therapy

N = 33 (16/17)

Age: 41

100%

CDC-94/Fukuda

60–90 min

weekly

3 weeks

Post

COPM, CIS, SF-36, CFS symptom list

No

1/3

No

Post: CIS p < 0.05, SF-36-PF and other scores ns No adverse events

ASPM is feasible and effective in increasing participation in daily life activities and decreasing fatigue in women with CFS

Taylor et al. 2004 [75]

USA

Immediate program group: peer-based, education, including activity pacing using the envelope theory

Delayed program group

N = 47 (23/24)

Age:47

91%/100%

CDC-94/Fukuda

8 Biweekly group sessions over 16 weeks + 7 months peer counseling

52, from baseline

CFSSRF (incl CFQ), QoL index

No

?

Yes

Long: Time × condition interaction: QoL, CFSSRF-Symptom severity: p < 0.05, CFQ. not reported, other items ns

Concl.: Patient driven programs like this can have a positive effect on symptom severity and QoL over time in CFS/ME

Meeus et al. 2010 [65]

Belgium

Pain physiology education

Pacing and self-management education

N = 48 (24/24)

Age: 40

92%/75%

CDC-94/Fukuda

Once 30 min education

Post

1: NPT

2: PCI, PCS, TSK, pressure pain threshold

No

None

No

Post: NPT p < 0.001, PCS-rumination, -worry, -distraction p < 0.05, other PCI-scales, TSK, Pain thresholds ns

Pain education results in better understanding of pain and less catastrophizing at short term

Wallman et al. 2004 [73]

Australia

GET with pacing

Flexibility and relaxation

N = 68 (34/34)

Age: 43

77%

CDC-94/Fukuda

max 30 min/ss

3–4 ss/week

12 weeks

4 post

PGIC, HADS, CFQ, Activity levels, Stroop test, physiological assessments (HR, BP, VO2,RER, net blood lactate production), RPE OAESI

No

2/5

No

Post: CFQ, HADS-depr, physiological assessments resting (except diastolic BP) and exercise, Stroop test p < 0.05/ns, HADS-anx, RPE, PGIC−/ + r: 0/60%, activity level: ns

Concl: GET was associated with improvements in physical work capacity, as well as in specific psychological and cognitive variables

Thomas et al. 2008 [61]

UK

Multi-convergent

therapy (MCT), including CBT, GET and pacing

Relaxation therapy

(+ non-randomized control)

N = 31 (17/14)

Age: 48/45

71%

CDC-94/Fukuda

10 1 h ss, 10 weeks

Post

26

1: Karnofsky performance scale

2: PGIC overall, function, fatigue

Yes

5/0

No

Post: Karnofsky (83% vs 21% normal score, consultant-rated), PGIC overall p < 0.001, PGIC fatigue p < 0.001, PGIC function p < 0.05

Short: PGIC p < 0.001, PGIC fatigue p < 0.001, PGIC function p < 0.05

No adverse events

Concl: MCT seemed more effective than relax therapy

Vos-Vromans et al

2016 [66] (2012 [76])

The Netherlands

MRT (CBT, gradual reactivation, body awareness therapy, pacing, social reintegration)

CBT

N = 122 (60/62)

Age: 40

80%

CDC-94/Fukuda criteria

CBT: 45–60 min,

16 ss, 6 months

MRT: 33 h,

10 weeks

26 basel (post)

52 basel

1: CIS-f, SF-36

2: SES, SCL-90, MAAS, SIP-8, CAL, LSQ, EET, PSCG, activity monitor

Yes, but no reported

6/12

Yes

Short: CIS: ns, SF-36-MCS ns, SF-36-PCS ns, SES p < 0.05, PSCG < 0.001, all others ns

Long: CIS p < 0.05, SF-36-MCS ns, SF-36-PCS ns, SES p = 0.01, PSCG < 0.001, EET < 0.05 all others ns

Concl: MRT is more effective than CBT in reducing long-term fatigue severity in CFS

Clark et al

2017 [63], (2016 [124])

UK

Guided graded exercise self-help (GES) and four guidance sessions with physiotherapist

SMC

N = 211 (97/102)

Age: 38

82%/76%

NICE (71% CDC-94 and 81% Oxford)

8 weeks

12 rand

52 rand

1: SF-36-PF, CFQ

2: PGIC-health adverse outcomes, PGIC, HADS, PHQ-13, WSAS, IPAQ,

Yes

29%/–

Yes

Short: CFQ p < 0.001; SF-36-PF p < 0.01, WSAS p < 0.05, HADS p < 0.01, IPAQ p < 0.001, PHQ-13, PGIC−/+ : 0/14%, ns

Long: not reported (yet?)

No serious adverse reactions, serious deterioration: ns

Concl: GES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for CFS

Moss-Morris et al. 2005 [74]

New Zealand

GET

SMC

N = 49 (25/24)

Age: 41

71%

CDC-94/Fukuda

12 weeks

Post

42 basel

PGIC, CFQ, SF-36-PF, VO2 peak (treadmill), IPQ-R, IMQ

No

3/–

Yes

Post: PGIC−/ + : –/56% p < 0.05, CFQ: p < 0.05, IMQ-symptom focus p < 0.05

SF-36-PF, VO2 peak, IPQ-R: ns

Short: Phys. CFQ < 0.05, mental CFQ, SF-36-PF ns

Concl: GET appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms

Nùñez et al. 2011 [68]

Spain

MRT (group CBT- and GET, and conventional pharmacological treatment)

Exercise counselling

(and conventional pharmacological treatment)

N = 120 (60/60)

Age: 43

93% / 14%

CDC-94/Fukuda criteria

CBT: 90 min, 9 ss,

GET: 60 min, 9 ss

10–12 weeks

52 post

1: SF-36

2: HAQ, HADS, FIS

SF-36 reduced

2/3

No

Long: SF-36-BP: (C) (p < 0.05), other results ns

Concl: MRT was not superior to usual treatment at 12 months in terms of HRQL (SF-36). The combination of GET and CBT is ineffective and might be harmful to some patients

Sutcliffe et al. 2010 [62]

UK

Home orthostatic (tilt) training (HOT)

Sham training

N = 38 (19/19)

Age: 48

84% / 79%

CDC-94/Fukuda

40 min. 26 weeks

4 rand (mid treatment)

Post

1: Compliance/tolerability

2: FIS, hemodynamic parameters

Yes, but not reported

5/5

No

Short: FIS: ns, systolic blood pressure drop with active stand p < 0.05, other hemodynamics ns

Concl: HOT is well tolerated and generally complied with

Oka et al. 2014 [72]

Japan

Isometric sitting yoga (and pharmacotherapy)

Waitlist (pharmacotherapy alone)

N = 30 (15/15)

Age: 38

80%

CDC-94/Fukuda

20 min 5.8x/week, 9.2 weeks (mean 5.6ss with instruction)

Post

8

POMS (F and V), CFQ, SF-8, occurrence

Yes

None

No

Post: POMS-F p < 0.001, POMS-V p < 0.01

Short: CFS p < 0.01, SF-8 total ns. Absence of serious adverse events or PEM

Concl: Isometric yoga reduced fatigue and improved vigor

Chan et al. 2014 [69]

Hong Kong

Qigong (Baduanjin)

Waitlist

N = 150 (75/75)

Age: 39

46%/62%

CDC-94/Fukuda

16 lessons of 1.5 h over 9 weeks

Post

12 post

PSQI, CFQ, HADS, PGIC

Yes

4–49/–

Yes

Short: PSQL: ns, CFQ: p < 0.001, HADS < 0.05/ < 0.001. PGIC−/ + : –/68%. Except muscle ache, adverse events were uncommon

Concl: Qigong was an efficacious and acceptable treatment for sleep disturbance in CFS

Chan et al. 2013 [70]

Hong Kong

Qigong

Waitlist

N = 154 (77/77)

Age: 42

72% / 82%)

CDC-94/Fukuda

2 times/week

5 weeks + 12 weeks home-based practice

Post

CFQ, HADS

Yes

5/12

Yes

Post: CFQ, HADS p < 0.001

No adverse events were reported

Concl: Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect

Ho et al. 2012 [71]

Hong Kong

Qigong

Waitlist

N = 70 (35/35)

Age = 42

76% / 84%

CDC-94/Fukuda

5 weeks group qigong + 12 weeks home-based practice

Post

CFQ, SF-12

Yes

8/10

Yes

Post: SF-12-PF: ns CFQ, SF-36 MF: p < 0.001

No adverse effects were reported

Concl: Qigong exercise may improve CFS and mental functioning

  1. Ss: sessions: ns non-significant, CBT: Cognitive Behavioural Therapy; GET: Graded exercise therapy; MRT: Multidisciplinary Rehabilitation Treatment; SMC: Specialist Medical Care, BP: blood pressure; CAL: Causal Attribution List; CFQ: Chalder Fatigue scale/Questionnaire; CFSSRF: Chronic Fatigue Syndrome Symptom Rating Form; CIS/CIS-f: Checklist Individual Strength – Fatigue severity subscale; COMP: Canadian Occupational Performance Measure; EET: Improvement and Satisfaction questionnaire; EQ-5D: Euroqol Questionnaire; FIS: Fatigue Impact Scale; HADS: Hospital Anxiety and Depression Scale; HAQ: Health Assessment Questionnaire; HR: heart rate; IMQ: Illness Management Questionnaire: IPQ: Illness-Perception Questionnaire; LSQ: Life Satisfaction Questionnaire; MAAS: Mindfulness Attention Awareness Scale; NPT: Neurophysiology of Pain Test; OAESI: Older Adult Exercise Status Inventory; PAQ: International Physical Activity Questionnaire; PCI: Pain Coping Inventory; PCS: Pain Catastrophizing Scale; PGIC: Patient Global Impression of Change; PGICdet/impr: PGIC (very) much worse/better; PHQ-13: Patient Health Questionnaire-13; POMS: Profile of Mood States, Fatigue and Vigor; PSCG: Patient-Specific Complaints and Goals questionnaire; RPE: Ratings of perceived exertion; RER: respiratory exchange ratio; SF-8/12/36: Short Form Health Survey (–PF physical functioning, -MF mental functioning - BP: Bodily Pain, -PCS: physical component summary, -MCS mental component summary); SCL-90: Symptom Check List-90; SES: Self-Efficacy Scale; SIP-8: Sickness Impact Profile, 8 items; TSK: Tampa Scale of Kinesiophobia; VO2 oxygen uptake; WSAS: Work and Social Adjustment Scale
  2. aRand: from randomisation moment, basel.: from baseline, post: (at) post-treatement
  3. bData for at least one key outcome was analyzed by ‘intention to treat’ analysis (ITT)
  4. cResults in favour of intervention. If results favours comparison intervention, ‘[C]’ is added. Post: post-treatment, Short-time follow-up, Long-longtime follow-up
  5. d‘Second-version’, with unknown modifications