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

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Duncan 2003<br />

Methods Design: randomised trial of mixed <strong>training</strong> versus usual care - after usual care (outpatient)<br />

Randomisation mechanism: unknown; method: blocks of 6<br />

Allocation concealment: sealed envelopes<br />

Blinding: investigator; participants asked to maintain blinding<br />

Intention-to-treat: yes<br />

Measurements: end of intervention (12/14 weeks) and 6-month follow-up<br />

Withdrawals: intervention (10 participants: 6 be<strong>for</strong>e (1 renal insufficiency, 1 subclavian<br />

steal syndrome, 1 chose withdrawal, 3 recurrent <strong>stroke</strong>) 4 after the 3-months follow up (1<br />

died, 1 hospital, 2 recurrent <strong>stroke</strong>); control (11 participants: 2 be<strong>for</strong>e (1 withdrew, 1 nonreturn),<br />

9 after 3-months follow-up (2 died, 2 hospital, 5 withdrew)<br />

Participants Randomised: 100 participants<br />

Intervention: 50 participants; 23 males and 27 females; age 68.5 years (SD 9.0); 77.5 days<br />

post-<strong>stroke</strong> (SD 28.7)<br />

Control: 50 participants; males and 27 females 23; age 70.2 years (SD 11.4); 73.5 days<br />

post-<strong>stroke</strong> (SD 27.1)<br />

Inclusion criteria: 30 to 150 days post-<strong>stroke</strong>; independent ambulation <strong>for</strong> 25 feet; Fugl-<br />

Meyer scores 27 to 90; Orpington Prognostic Scale 2.0 to 5.2); Folstein Mini-Mental State<br />

score 16<br />

Exclusion criteria: serious cardiac condition; oxygen dependence; severe weight bearing<br />

pain; serious organ system disease; life expectancy < 1 year<br />

Interventions Intervention: mixed <strong>training</strong>, per<strong>for</strong>med approximately 90 minutes per day 3 days per<br />

week <strong>for</strong> 12 to 14 weeks (36 sessions); <strong>training</strong> included range of motion and flexibility,<br />

strength <strong>training</strong>, balance, functional upper extremity practice, endurance <strong>training</strong> via<br />

interval <strong>training</strong> on cycle ergometer. All elements progressive but intensity not quantified<br />

Control: usual outpatient care including physiotherapy and occupational therapy <strong>for</strong> participants<br />

who needed. All controls received 30-minute visit every 2 weeks including provision<br />

of health promotion in<strong>for</strong>mation<br />

Setting: home-based, therapist-supervised <strong>for</strong> first 8 weeks<br />

Outcomes Included outcomes: cognitive and motor subscales of the FIM; SF-36 subscales; ankle<br />

dorsiflexion and knee extension isometric strength (Nm); isometric grip strength (N);<br />

BBS; functional reach; VO2 peak; gait speed preferred (10-metre); 6MWT; community<br />

ambulation (> 0.8 metres/second)<br />

Other outcomes: Stroke Impact scale; cycle duration; Fugl Meyer scores<br />

Notes Some outcomes reported as change from baseline scores. Others reported as means at end<br />

of 6-month follow-up<br />

Risk of bias<br />

Bias Authors’ judgement Support <strong>for</strong> judgement<br />

Allocation concealment (selection bias) Low risk Sealed envelopes<br />

<strong>Physical</strong> <strong>fitness</strong> <strong>training</strong> <strong>for</strong> <strong>stroke</strong> <strong>patients</strong> (<strong>Review</strong>)<br />

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.<br />

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