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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Treatment withdrawn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