Physical fitness training for stroke patients (Review) - Update Software

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.
Intention-to-treat: 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
Allocation concealment (selection bias) Unclear risk Opaque envelopes (sealed?)
Physical fitness training for stroke patients (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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