Condition category
Circulatory System
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nancy E Mayo

ORCID ID

Contact details

Royal Victoria Hospital
Division of Clinical Epidemiology
687 Pine Avenue West
Ross Pavillion 4.29
Montreal
H3A 1A1
Canada
+1 514 842 1231 (36922)
nancy.mayo@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-66794

Study information

Scientific title

Acronym

FITS

Study hypothesis

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

Institutional Review Board, McGill, Faculty of Medicine, Montreal, Québec (Canada), 29/11/2002.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2003

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant 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

Recruitment start date

01/04/2003

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Canada

Trial participating centre

Royal Victoria Hospital
Montreal
H3A 1A1
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

845 Sherbrooke Street West
James Administration Bldg.
Suite 429
Montreal
H3A 2T5
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66794)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes