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Clinical Trials/NCT00786045
NCT00786045
Completed
Not Applicable

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

McGill University1 site in 1 country60 target enrollmentNovember 2002
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
McGill University
Enrollment
60
Locations
1
Primary Endpoint
Functional Walking Capacity (6 Minute (walk test)
Status
Completed
Last Updated
13 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2002
End Date
November 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nancy Mayo

BSc(PT), MSc, PhD

McGill University

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

Outcomes

Primary Outcomes

Functional Walking Capacity (6 Minute (walk test)

Time Frame: baseline, 1 month, 6 months, 12 months

Secondary Outcomes

  • Quality of Life (SF-36)(Baseline, 1 month, 6 month, 12 month)

Study Sites (1)

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