Moss‐Morris 2005

Methods	RCT, 2 parallel arms
Participants	Diagnostic criteria: CDC 1994 Number of participants: N = 49 Gender: 34 (69%) female Age, mean (SD): 40.9 years: 36.7 (11.8) in treatment group and 45.5 (10.5) in control group Earlier treatment: NS Co‐morbidity, mean (SD): 14 (29%) possible or probable cases of depression (HADS). HADSAnxiety 6.72(3.44) in treatment group and 7.17 (3.43) in control group. HADSDepression 5.70 (2.69) in treatment group and 6.70 (0.67) in control group. Use of antidepressant not stated Illness duration, median (range): 3.1 years, 2.67 (0.6 to 20) in treatment group and 5 (0.5 to 45) in control group Work and employment status: 11 (22%) unemployed and unable to work because of disability Setting: specialist CFS general practice Country: New Zealand
Interventions	Group 1: graded exercise therapy (12 weeks), met weekly, final goal 30 minutes for 5 days a week, 70% of VO2max (n = 25) Group 2: standard medical care provided by a CFS specialist physician (n = 24)
Outcomes	Changes in overall health (Global Impression Scale, score between 1 and 7, where 1 = very much better, 4 = no change) Physical function (SF‐36 physical function subscale score) Fatigue (Fatigue Scale, FS) Activity levels Cognitive function Physiological assessments (e.g. maximum aerobic capacity, HR) Acceptability Outcomes assessed at end of treatment (12 weeks). A self‐report questionnaire was distributed at 6 months' follow‐up and was returned by 16 exercise participants and 17 control participants
Notes	The exact components involved in 'treatment as usual' are not explained
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...randomised into either treatment or control conditions by means of a sequence of computer generated numbers placed in sealed opaque envelopes by an independent administrator"
Allocation concealment (selection bias)	Low risk	Quote: "placed in sealed opaque envelopes by an independent administrator"
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	3 of 25 participants (12%) dropped out from exercise treatment. Reasons for drop‐out: 1 had to return to the USA, 1 had an injured calf and 1 was not reached at follow‐up. 3 of 24 patients (12.5%) in control group did not return follow‐up questionnaire at 12 weeks. To determine whether drop‐out affected the calculated treatment effect, study authors completed intention‐to‐treat analysis
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