Fitness intervention trial post-stroke (FITS): Enhancing walking endurance using home rehabilitation programs
ISRCTN | ISRCTN45155177 |
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DOI | https://doi.org/10.1186/ISRCTN45155177 |
Secondary identifying numbers | MCT-66794 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 17/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nancy E Mayo
Scientific
Scientific
Royal Victoria Hospital
Division of Clinical Epidemiology
687 Pine Avenue West
Ross Pavillion 4.29
Montreal
H3A 1A1
Canada
Phone | +1 514 842 1231 (36922) |
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nancy.mayo@mcgill.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | FITS |
Study objectives | 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 capacity compared with the 'walking' group and that consequently the cycle group will achieve a higher quality of life. |
Ethics approval(s) | Institutional Review Board, McGill, Faculty of Medicine, Montreal, Québec (Canada), 29/11/2002. |
Health condition(s) or problem(s) studied | Stroke |
Intervention | Group 1 is assigned to The Disability-Tailored Walking Competency Home Program: We have devised a series of mobility-related tasks that can be easily and safely carried out at home without ongoing professional supervision. These tasks are similar to those used in our recent laboratory-based study but have been adapted for the home environment. A physical therapist, based on his or her evaluation of the participant, will choose a number of these tasks for the home program and train subjects to carry out these tasks safely and effectively in their own homes. The choice will depend on the capacity of each person and the home environment. Each person will be visited at home on a regular basis to adjust the program as needed. Persons will be instructed to try to carry out a minimum of 15 minutes of exercise per day. Each task is designed to be carried out for a minute with a one minute rest between exercises. Brisk walking will be recommended to complete the 15 minute time recommendation. Progression will be to more difficult tasks and then by adding weights or repetitions. The aim is to build up to one-half hour of exercise per day including walking. Group 2 is assigned to The 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 on 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. Trial details received 12 Sept 2005 |
Intervention type | Other |
Primary outcome measure | Walking endurance (6 minute walk test [6MWT]) measured at 12 months after recruitment |
Secondary outcome measures | 1. Health Related Quality of Life (HRQOL) 2. Gait Speed 3. Balance 4. Community Re-Integration 5. Stroke Specific Quality of Life 6. Fatigue 7. Depression 8. Anxiety 9. Anger |
Overall study start date | 01/04/2003 |
Completion date | 30/04/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 130 |
Key inclusion criteria | 1. Verified stroke requiring hospital admission (based on clinical and radiological evidence) 2. Aged 50 years and older, either sex 3. Ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision 4. Less than one year since the last cerebrovascular event at the time of recruitment 5. 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 |
Key exclusion criteria | 1. 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 2. Receptive aphasia as evaluated by the Canadian Neurological Scale or the treating speech therapist 3. Illness or disability precluding participation in either rehabilitation intervention 4. Failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test |
Date of first enrolment | 01/04/2003 |
Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
Royal Victoria Hospital
Montreal
H3A 1A1
Canada
H3A 1A1
Canada
Sponsor information
McGill University (Canada)
Not defined
Not defined
845 Sherbrooke Street West
James Administration Bldg.
Suite 429
Montreal
H3A 2T5
Canada
https://ror.org/01pxwe438 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66794)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |