Fitness Intervention Trial for Stroke

Stroke Clinical Trial

— FITS  

Official title:

Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786045
• Other study ID #: A11-M107-02A
• Secondary ID: MCT_66794
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: April 26, 2013
• Start date: November 2002
• Est. completion date: November 2009

Study information

• Verified date: April 2013
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University-Royal Victoria Hospital Site	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Walking Capacity (6 Minute (walk test)		baseline, 1 month, 6 months, 12 months	No
Secondary	Quality of Life (SF-36)		Baseline, 1 month, 6 month, 12 month	No