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. 2016 Mar 24;2016(3):CD003316. doi: 10.1002/14651858.CD003316.pub6

Ivey 2011

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