Bateman 2001

Methods	Design: multicentre randomised trial of cardiorespiratory training plus usual care versus non‐exercise intervention plus usual care ‐ during usual care Randomisation: mechanism ‐ computer; method ‐ blocks size of 10 participants Allocation concealment: numbered, sealed envelopes Blinding: investigator blinded; participants encouraged to maintain blinding; efficacy unknown ITT: yes, but participants were excluded after recruitment and baseline assessments due to discharge Measurements: end of intervention (12 weeks) and at follow‐up Withdrawals: intervention group (12 participants: 4 before and 8 after the 12‐week assessment); control group (12 participants: 2 before and 10 after the 12‐week assessment) Reasons unclear but included early discharge
Participants	Randomised: 84 participants Intervention: 40 participants; males 20, females 20; age 47.0 years (SD 13.1); 144 days (SD 84) post‐stroke Control: 44 participants; males 29, females 14; age 50.3 years (SD 10.1); 184 days (SD 127) day post‐stroke Inclusion criteria: single stroke; could comply with planned interventions; could sit on a cycle ergometer Exclusion criteria: likely to be inpatient for < 3 months; impairments severe enough to limit training compliance and participation; cardiac disease; co‐morbidities contraindicated for exercise
Interventions	Intervention: cardiorespiratory training; cycle ergometry at 60% to 80% of age‐related heart rate maximum for up to 30 minutes per day 3 days per week for 12 weeks Control: relaxation ‐ programme individualised: included breathing exercises, progressive muscle relaxation, autogenic exercises, visualisation techniques Setting: multicentre, 4 rehabilitation units
Outcomes	Included outcomes: FIM; BI (0 to 20 scale); NEADL; RMI; HADS; BBS; gait maximum speed; maximum cycling workload (data transformed to Log base e); BMI Other outcomes: fatigue questionnaire
Notes	Mixed brain injury data provided by authors; stroke‐only data retained and re‐analysed. High rate of missing data made statistical analyses difficult
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐based block (n = 10) randomisation
Allocation concealment (selection bias)	Low risk	Numbered, sealed envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Attention control
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigator blinded; participants encouraged to maintain blinding; efficacy unknown
Incomplete outcome data (attrition bias) End of intervention	High risk	ITT employed 6/84 (7%) lost: intervention group 4; control group 2 Reasons for losses not clear but included exclusion after recruitment and baseline assessments due to discharge Large amounts of missing outcome data
Incomplete outcome data (attrition bias) End of follow‐up	High risk	ITT employed 24/85 (29%) total losses; intervention group 8; control group 10
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Other bias	Unclear risk	Unclear
Imbalanced exposure	Low risk	Balanced exposure