Lennon 2008

Methods	Design: pilot randomised study of cardiorespiratory training versus usual care ‐ after usual care. Sample size calculation reported Randomisation: stratified randomisation (by age and sex) into 4 blocks of 6 using a sequence generator by an independent party Allocation concealment: opaque envelopes Blinding: single‐blinded; unclear who was blinded ITT: no but only 1 participant dropped out in the control group Measurements: end of intervention (10 weeks) Withdrawals: 1 participant (refusal) in the control group
Participants	Randomised: total 48 participants. Participants were recruited from the Stroke Rehabilitation Database (Dublin). Volunteers contacted the research team for initial screening Intervention: 24 participants; 14 males (58%) and 10 females (42%); mean age 59.0 years (SD 10.3); mean number of weeks from stroke 237.3 (SD 110.7) Control: 24 participants; 14 males (58%) and 10 females (42%); mean age 60.5 years (SD 10.0); mean number of weeks from stroke 245.3 (SD 169.8) Inclusion criteria: > 1 year post ischaemic stroke and over 18 years of age; participants were recruited irrespective of their ability to ambulate independently Exclusion criteria: O2 dependence, angina, unstable cardiac conditions, uncontrolled diabetes mellitus, major medical conditions, claudication, cognitive impairment, or beta blocker medication
Interventions	Intervention: the Cardiac Rehabilitation Programme consisted of cycle ergometry training using either the upper or lower limbs. Exercise load was set at 50% to 60% of the participants' maximal heart rate. Resistance and speed were adjusted daily to ensure progression. Frequency: participants trained twice weekly for 30 minutes each time, for 10 weeks. Measurements performed at week 1 and re‐assessment at week 10. All sessions were supervised by a physiotherapist Control: conventional physiotherapy and occupational therapy; no therapy contained an aerobic exercise component; measurements at week 1 and re‐assessment at week 10. No further details provided Setting: outpatient rehabilitation
Outcomes	Included outcomes: VO2; BMI; maximum cycle workload; resting systolic blood pressure; resting diastolic blood pressure; total cholesterol; FAI; HADS Other outcomes: resting heart rate; cardiac risk score; rate of perceived exertion
Notes	The trial authors maintained that their pilot study was too small for detecting functional benefits (a minimum of 120 participants in each group would have been required to show expected change in all primary outcomes); possible Hawthorn effect due to the fact that the control group did not receive the comparable non‐exercise related attention to the intervention group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified randomisation (by age and sex) into 4 blocks of 6 using a sequence generator by an independent party
Allocation concealment (selection bias)	Unclear risk	Opaque envelopes; sealed and numbered unknown
Blinding (performance bias and detection bias) All outcomes	High risk	Control group did not receive the comparable non‐exercise related attention to the intervention group
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear who was blinded
Incomplete outcome data (attrition bias) End of intervention	Low risk	No ITT analysis 1/48 (2%) participant dropped out 1 (refusal) in the control group
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Other bias	Unclear risk	Unclear
Imbalanced exposure	High risk	Imbalanced exposure