Methods |
RCT Method of randomisation: computer‐based list Blinding of outcome assessors: stated as 'yes' by the investigator Adverse events: not stated Deaths: not stated Drop outs: 42 (20 in EXP group, 22 in CTL group) ITT: no |
Participants |
Country: USA 113 participants (57 in EXP group, 56 in CTL group) Ambulatory at study onset Mean age: 64 to 63 years (CTL and EXP group respectively) Inclusion criteria: first clinical ischaemic stroke, older than 45 years of age with chronic hemiparetic gait 6 or more months after completion of conventional subacute rehabilitation Exclusion criteria: heart failure, unstable angina, peripheral arterial occlusive disease, dementia (MMSE ≤ 23 for those with 9th grade education or more and ≤ 17 for those with 8th grade education or less), significant aphasia (unable to follow 2‐point commands), untreated major depression (CES‐D 16) and other medical conditions precluding participation in aerobic exercise |
Interventions |
2 arms:
treadmill training sessions (training goal was 3 x 40‐minute exercise sessions per week at an aerobic intensity of 60% of heart rate reserve. Duration and intensity started low (10 to 20 minutes, 40% to 50% heart rate reserve) and increased approximately 5 minutes and 5% heart rate reserve every 2 weeks as tolerated
stretching sessions (performed 13 supervised traditional stretching movements on a raised mat table with a therapist’s assistance) over a 6‐month period
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Outcomes |
Assessed at baseline, 3 and 6 months:
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐based list |
Allocation concealment (selection bias) |
High risk |
Not described |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Blinded assessors |