Does Aerobic or Resistance Exercise Training Improve Walking Ability in Chronic Stroke Patients?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sydney
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Subjects will undertake a 6 min walking test for maximum distance
Study Overview
Brief Summary
This study will investigate the efficacy of aerobic exercise and progressive resistance training (PRT), singularly and combined, on changes in walking endurance for mildly-to-moderately affected chronic stroke patients. Specifically, we will determine the relative importance of training induced changes in muscle strength versus aerobic fitness on increases in gait velocity and 6-min walking distance, and assess the concomitant functional and psychosocial impact of increased muscle strength, aerobic fitness and improved gait. This longitudinal study will be conducted as a double blinded factorial randomized controlled trial of exercise training for chronic stroke patients.
Detailed Description
The experimental hypotheses are:
- Participation in a 10-week exercise program consisting of aerobic, resistance or combined aerobic+resistance training will produce a 20% or greater increase of 6-min walking distance compared to controls.
- Aerobic fitness will increase equally in the combined aerobic+resistance program and aerobic program alone, greater than that in the resistance program only, where effect is measured in terms of maximal and submaximal cardiorespiratory exercise performance.
- Lower limb muscle strength will increase equally in the combined aerobic+resistance program and resistance program alone, greater than the increase in strength for aerobic training, where effect is measured in terms of measures of lower limb strength, power and endurance.
Research Plan Synopsis:
To determine treatment efficacy, a 2x2 factorial double-blinded randomized controlled trial will be conducted, the two factors being aerobic training and PRT. Forty-eight subjects will be randomly allocated to one of four groups comprising (i) aerobic exercise training [AEROBIC; n=12]; (ii) PRT [RESISTANCE; n=12]; (iii) combined aerobic training and PRT [AEROBIC+RESISTANCE; n=12], or (iv) control [CONTROLS; n=12]. AEROBIC and RESISTANCE groups will also include a "sham" treatment for the other factor, and the order of presentation of treatment versus "sham" will also be randomized within each exercise session. All subjects will attend 3 times per week for 10 weeks. Subjects will be recruited from various hospitals, peer support groups and previous participants of an acute stroke research project that we are now conducting. All will be screened by a medical practitioner for inclusion and exclusion criteria and then allocated to one of the four groups by the trial coordinator.
Interventions:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 45 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 45 years
- •First stroke resulting in hemiplegia
- •At least 4-months post stroke
- •Residing at home or community-based (non-institutionalized) living environment
- •Self selected gait velocity between 0.42 m/s to 0.80 m/s
- •No longer receiving physiotherapy.
- •Adequate comprehension of instructions and perceptual abilities (assessed by stroke clinician during medical screening), no significant musculotendinous or bony restrictions of the affected limb, nor any serious chronic disease independently causing significant disability or profound atrophy of the affected limb will comprise further indications to participation
Exclusion Criteria
- •Subjects will be excluded if they have significant cardiac disease, symptom limiting peripheral vascular disease, or any of the exclusion criteria contraindicating moderate exercise as outlined by the American College of Sports Medicine guidelines for cardiac disease rehabilitation or for frail and elderly adults. The initial symptom-limited/maximal aerobic assessment will serve as the screening test for contraindications to further exercise.
Outcomes
Primary Outcomes
Subjects will undertake a 6 min walking test for maximum distance
Secondary Outcomes
- Cardiorespiratory Fitness
- Scales and questionnaires
- Lower limb muscular strength and endurance
- Mobility variables