Gunn 2007
| Trial name or title | The effectiveness of a higher intensity water‐based exercise program: a randomized controlled trial following stroke (pilot) ANZCTR registration title: The effectiveness of higher intensity water‐ and gym‐based exercise programs on gait speed: a randomised controlled trial following stroke (pilot) |
| Methods | Randomised controlled trial The study will compare 6 weeks higher intensity water‐based exercise with gym‐based exercise of similar intensity for people within 3 years of their first stroke |
| Participants | Country: Australia Inclusion criteria: 6 months to 3 years since first stroke (ischaemic stroke or primary intracerebral haemorrhage), community dwelling, independent ambulation with or without gait aids, Mini Mental State Exam score for at least 18, ability to accept instruction and give consent, a minimum age of 18 years Exclusion criteria: subsequent stroke, major medical complications following stroke, unstable cardiac conditions, urinary or faecal incontinence, open wounds, tinea, unstable epilepsy or seizures, other comorbid conditions that might contraindicate participation in gym‐ or water‐based exercise, inability to carry out the exercise program, current participation in an exercise program |
| Interventions | Intervention group: a water‐based intervention consisting of 3 pool sessions per week for a total of 6 weeks. Each session will be 40 minutes duration and consist of a standardised resistance program, the intensity of which will be varied according to each individual's ability, with progressive increase in load over the 6‐week period. Control group 1: gym‐based intervention consisting of 3 gym sessions per week for a total of 6 weeks. Each session will be 40 minutes duration and consist of a standardised resistance program, the intensity of which will be varied according to each individual's ability, with progressive increase in load over the 6‐week period. Control group 2: will consist of attendance at a chronic disease self‐management course once a week for 6 weeks. Each session will be 2.5 hours duration and will consist of instruction on how to manage symptoms, effectively communicate with your doctor, lessen frustration, fight fatigue, make daily tasks easier, and get more out of life. |
| Outcomes | Outcome measures: baseline, 6 weeks and 3 months post intervention Primary outcome: Six minute walk test Secondary outcomes: Modified Berg Balance Scale, Bioelectrical Impedance, Functional independence using the Modified Barthel Index, Goal Attainment Scale, Quality of Life using EuroQoL, Motor Assessment Scale, The Medical Outcomes Study (MOS) Sleep Scale, Fatigue Assessment Scale The people assessing the outcomes and the people analysing the results/data are masked/blinded |
| Starting date | Anticipated or actual date of first participant enrolment: 1 October 2007 |
| Contact information | Dr Simon Gunn Repatriation General Hospital Daws Road Daw Park SA 5041 Australia Tel: 08 8275 1103 Fax: 08 8275 1130 Email: simon.gunn@rgh.sa.gov.au |
| Notes | ACTR Number: ACTRN12607000506493 Target sample size: 45 http://www.anzctr.org.au/trial_view.aspx?ID=82304 |