Fitness Intervention Trial for Stroke (FITS)
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Purpose
The objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling and a disability targeted, home-based exercise program to enhance mobility and walking competency. capacity compared with the "walking" group and that consequently the cycle group will achieve a higher quality of life.
A secondary objective is to explore factors associated with compliance with the exercise regimens. Previous research has indicated that cognitive-affective-behavioural profile is related to exercise activity in a number of populations including sedentary adults, older adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms by which the cycling will result in an outcome better than the more traditional type of disability tailored exercise program is through greater compliance, this second objective is very relevant. This study will also address the impact of regular exercise on cardio-vascular risk factor profile.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: Home Cycling Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs |
- Functional Walking Capacity (6 Minute (walk test) [ Time Frame: baseline, 1 month, 6 months, 12 months ] [ Designated as safety issue: No ]
- Quality of Life (SF-36) [ Time Frame: Baseline, 1 month, 6 month, 12 month ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | November 2002 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Home Cycling Program
Participants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate.
|
Other: Home Cycling Program
Participants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate.
|
|
No Intervention: Control
The investigators have devised a series of mobility-related tasks that can be easily and safely carried out at home without ongoing professional supervision
|
Detailed Description:
The specific clinical hypothesis to be tested is that, over a one year period, persons assigned to the general fitness "cycle" group will experience a greater increase in functional exercise
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- verified stroke requiring hospital admission (based on clinical and radiological evidence)
- ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision,
- less than one year since the last cerebrovascular event at the time of recruitment,
- discharge from active rehabilitation (usually around 3 to 4 months post-stroke but not less than 1 month) into the geographic study area of greater Montreal and greater Halifax.
Exclusion Criteria:
- severe cognitive deficits as evaluated by the Telephone Version of the Mini-Mental State Examination such that the subject does not understand their participation in the study,
- receptive aphasia as evaluated by the Canadian Neurological Scale48 or the treating speech therapist,
- illness or disability precluding participation in either rehabilitation intervention.
- failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test
Contacts and Locations| Canada, Quebec | |
| McGill University-Royal Victoria Hospital Site | |
| Montreal, Quebec, Canada, H3A-1A1 | |
| Principal Investigator: | Nancy E Mayo, PhD | McGill University, Division of Clinical Epidemiology |
More Information
No publications provided
| Responsible Party: | Nancy Mayo, BSc(PT), MSc, PhD, McGill University |
| ClinicalTrials.gov Identifier: | NCT00786045 History of Changes |
| Other Study ID Numbers: | A11-M107-02A, MCT_66794 |
| Study First Received: | November 4, 2008 |
| Last Updated: | April 26, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University:
|
stroke rehabilitation walking |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013