Methods | Design: randomised trial of cardiorespiratory training versus usual care ‐ after usual care Randomised: mechanism unknown Allocation concealment: unknown Blinding: unknown ITT: no Measurements: end of intervention (6 months) Withdrawals: 13 participants withdrew at the end of intervention, reasons unknown |
|
Participants | Randomised: 38 participants completed study; 51 may have been randomised Intervention: 19 participants; mean age 61 years (SD 8) Control: 19 participants; mean age 62 years (SD 10) Inclusion criteria: chronic hemiparetic stroke with mild to moderate hemiparetic gait; completed all conventional usual care; still present with residual hemiparetic gait deficits more than 6 months post‐stroke Exclusion criteria: inability for insonation of the middle cerebral artery bilaterally |
|
Interventions | Invention group: treadmill training for 40 minutes 3 times/week for 6 months at a target intensity of 60% to 70% heart rate reserve, initially started with discontinuous training which progressed to continuous Control group: usual care: 13 targeted active and passive supervised stretching movements of the upper and lower body for 30 to 40 minutes 3 times/week for 6 months Setting: rehabilitation unit |
|
Outcomes | Included outcomes: 6‐MWT, peak aerobic capacity during treadmill protocol Other outcomes: middle cerebral artery blood flow velocity bilaterally during normocapnia and hypercapnia (6% CO2) |
|
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Mechanism not described, number randomised not clear |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | High risk | Attention control was included |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) End of intervention | High risk | ITT analysis not reported There may have been losses after randomisation; up to 13/51 (25%) |
Selective reporting (reporting bias) | Unclear risk | Relationship to trial register entries unclear |
Other bias | Unclear risk | Unclear |
Imbalanced exposure | Low risk | Matched exposure |