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ISRCTN
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ISRCTN45155177
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ClinicalTrials.gov identifier
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Public title
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Fitness intervention trial post-stroke (FITS): Enhancing walking endurance using home rehabilitation programs
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Scientific title
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Acronym
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FITS
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Serial number at source
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MCT-66794
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Institutional Review Board, McGill, Faculty of Medicine, Montreal, Québec (Canada), 29/11/2002.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2003
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Anticipated end date
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30/04/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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130
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Interventions
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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
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Primary outcome measure(s)
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Walking endurance (6 minute walk test [6MWT]) measured at 12 months after recruitment
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66794)
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Trial website
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Publications
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Contact name
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Dr
Nancy E
Mayo
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Address
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Royal Victoria Hospital
Division of Clinical Epidemiology
687 Pine Avenue West
Ross Pavillion 4.29
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City/town
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Montreal
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Zip/Postcode
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H3A 1A1
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Country
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Canada
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Tel
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+1 514 842 1231 (36922)
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Fax
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+1 514 843 1493
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Email
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nancy.mayo@mcgill.ca
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Sponsor
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McGill University (Canada)
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Address
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845 Sherbrooke Street West
James Administration Bldg.
Suite 429
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City/town
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Montreal
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Zip/Postcode
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H3A 2T5
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Country
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Canada
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Date applied
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18/11/2005
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Last edited
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17/09/2008
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Date ISRCTN assigned
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18/11/2005
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