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Sponsored by: |
University of Sydney |
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Information provided by: | University of Sydney |
ClinicalTrials.gov Identifier: | NCT00108030 |
The specific aim of this project is to improve walking ability in persons following stroke using 'treadmill training plus power training'. This modality addresses the two major impairments followings stroke: weakness and incoordination, as well as loss of fitness. Importantly, this training will be presented at higher intensity and greater volume than is currently received. Furthermore, to ensure that persons continue to maintain the level of improvement from an intensive exercise program, we will also implement a behavioral change for long-term maintenance of exercise behavior in a less supervised environment. A randomized controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the efficacy of this approach to improving walking ability.
Hypotheses:
Condition | Intervention | Phase |
---|---|---|
Stroke |
Procedure: Partial Body-weight supported Treadmill Training Procedure: PBWST + Power training Procedure: "Usual" physiotherapy care |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | A RCT of Power Training and Treadmill Training to Improve Walking Ability in Sub-Acute Stroke Patients |
Estimated Enrollment: | 102 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2006 |
To determine treatment efficacy, a single blinded, randomized controlled trial will be conducted. One hundred and two subjects will be randomly allocated to one of three groups comprising: (i) “Treadmill training + Power training" (TT+POWER), (ii) “Treadmill training” (TT), or (iii) “Usual Care” (USUAL). Those in the TT+POWER and TT will also receive ‘usual care’. Subjects will be recruited within a week or two following their stroke, at which time they would be expected to be medically stable. Subjects in the training groups will attend training for 10 weeks, 3 times per week. Following the ten-week training program, subjects will be given a home-based training package to follow for 6 months.
Interventions:
Treadmill Training: The emphasis of the weight-supported treadmill training program will be initially to emphasize walking alignment. The amount of support will be reduced as quickly as possible to attain full weight-bearing on the motorized treadmill. Once a subject has attained full weight-bearing with correct segmental alignment, the emphasis will be on improving aerobic fitness whilst maintaining proper walking alignment.
Treadmill Training + Power Training: Subjects will undertake 30 min treadmill training, as described above, followed by 30 min of power training using pneumatic resistance equipment (Keiser Sports Health, Inc., Fresco, CA, USA) (leg press, knee extension and flexion, hip abduction, and plantarflexion). Standard principles governing frequency, volume, duration, and intensity of exercise known to provide maximal adaptation in both healthy and frail adults will be followed. Legs will be trained unilaterally.
Home-based program: Following 10 weeks of training, subjects will be given a home-based training program to continue indefinitely. Subjects in the TT+Power group will be given weights with instructions on use, and a walking program whereas those in the TT group will be given a walking program. To encourage compliance with the program, subjects will be telephoned weekly, and visited monthly. Subjects also will be requested to fill in a weekly log sheet detailing their exercise sessions and other physical activities, which is mailed to the trainer for feedback each week.
Outcomes: Outcomes will be measured prior to commencement of training, after 10 weeks training, and then after 6-months home based exercise. The Primary outcome is the distance walked in 6-min. This test was selected because walking distance is an important criterion for community ambulation. It is related to functional impairment as well as strength of the lower limb muscles and aerobic fitness, avoids the problem of gait velocity being relevant only for short-distance ambulation, and is a robust measurement.
Secondary Outcomes:
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon L Kilbreath, PhD | +61 2 9351 9466 | s.kilbreath@fhs.usyd.edu.au |
Australia, New South Wales | |
School of Physiotherapy, University of Sydney | Recruiting |
Sydney, New South Wales, Australia, 2141 | |
Contact: Sharon L Kilbreath, PhD +61 2 9351 9272 s.kilbreath@fhs.usyd.edu.au | |
Principal Investigator: Sharon L Kilbreath, PhD | |
Sub-Investigator: Maria F Singh, MD | |
Sub-Investigator: Brian Zeman, MBBS | |
Sub-Investigator: Glen Davis, PhD | |
Sub-Investigator: Jack Crosbie, PhD | |
Coorabel Brain Injury Unit, Royal Rehabilitation Centre Sydney | Recruiting |
Sydney, New South Wales, Australia | |
Contact: Brian Zeman, PhD +61 2 9808-9353 zemanb@doh.health.nsw.gov.au | |
Sub-Investigator: Brian Zeman, MBBS | |
Rehabilitation Research Centre, University of Sydney | Recruiting |
Sydney, New South Wales, Australia, 2141 | |
Contact: Glen M Davis, PhD, FACSM +61 2 9351 9466 g.davis@fhs.usyd.edu.au | |
Sub-Investigator: Glen M Davis, PhD |
Principal Investigator: | Sharon L Kilbreath, PhD | University of Sydney |
Study ID Numbers: | NHMRC 301974, Australia: NHMRC 301974 |
Study First Received: | April 12, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00108030 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
PBWST training Strength training 6-min walking endurance Cardiovascular fitness Psychosocial attributes |
Body Weight Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |