Clinical trial NCT00786045: Fitness Intervention Trial for Stroke
Official title: Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
walking
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-11-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Functional Walking Capacity (6 Minute (walk test)
timeFrame: baseline, 1 month, 6 months, 12 months
Secondary outcomes:
measure: Quality of Life (SF-36)
timeFrame: Baseline, 1 month, 6 month, 12 month
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University-Royal Victoria Hospital Site
state: Quebec
Study officials:
affiliation: McGill University, Division of Clinical Epidemiology
name: Nancy E Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayo NE, MacKay-Lyons MJ, Scott SC, Moriello C, Brophy J. A randomized trial of two home-based exercise programmes to improve functional walking post-stroke. Clin Rehabil. 2013 Jul;27(7):659-71. doi: 10.1177/0269215513476312. Epub 2013 Mar 15.