Fulcher 1997

Methods	RCT, 2 parallel arms
Participants	Diagnostic criteria: Oxford Number of participants: N = 66 Gender: 49 (65%) female Age, mean (SD): 37.2 (10.7) years Earlier treatment: NS Co‐morbidity: 20 (30%) possible cases of depression (HADS): 30 (45%) on full‐dose antidepressant (n = 20) or low‐dose tricyclic antidepressants as hypnotics (n = 10) Average illness duration: 2.7 (0.6 to 19) years Work and employment status: 26 (395) working or studying at least part time Setting: secondary care (chronic fatigue clinic in a general hospital of psychiatry) Country: UK
Interventions	Group 1: exercise therapy (12 sessions) with 1 weekly supervised session and 5 home sessions a week, initially lasting between 5 and 15 minutes (n = 33) Group 2: flexibility and relaxation (12 sessions) with 5 home sessions prescribed per week (n = 33)
Outcomes	Changes in overall health (Global Impression Scale, score between 1 and 7, where 1 = very much better, 4 = no change) Anxiety and depression (Hospital Anxiety and Depression Scale, HADS) Fatigue (Fatigue Scale, FS; 14‐item questionnaire) Sleep (Pittsburgh Sleep Quality Index, PSQI) Physical functioning (Short Form (SF)‐36) Physiological assessments (maximal voluntary contraction of quadriceps, peak oxygen consumption, lactate, heart rate) Perceived exertion (Borg Scale) Outcomes were assessed at end of treatment (12 weeks)
Notes	No long‐term follow‐up, as participants who completed the flexibility programme were invited to cross over to the exercise programme afterwards
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "determined by random number tables"
Allocation concealment (selection bias)	Low risk	Quote: "Randomisation was achieved blindly to the psychiatrist and independently of the exercise physiologist by placing the letter E or F in 66 separate blank envelopes. These were then arranged in random order determined by random number tables and opened by an independent administrator after baseline tests as each new patient entered the study"
Blinding (performance bias and detection bias) of participants and personnel?	High risk	Not possible to blind participants or personnel (supervisors) to treatment allocation
Blinding (performance bias and detection bias) of outcome assessors?	High risk	Blinding not possible for self‐reported measurements (e.g. FS, SF‐36)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "We completed follow up assessments on four of the seven patients who dropped out of treatment and included these data in the intention to treat analysis. Patients with missing data were counted as non­improvers"
Selective reporting (reporting bias)	Unclear risk	All primary outcomes stated under Methods were reported; however, as the trial protocol is not available, we cannot categorically state that the review is free of selective outcome reporting
Other bias	Low risk	We do not suspect other bias