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Completed

NCT Number: NCT00786045

Fitness Intervention Trial for Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University-Royal Victoria Hospital Site

Montreal, Quebec, H3A-1A1, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Cycling Program

Other

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.

Primary outcomes

  1. Functional Walking Capacity (6 Minute (walk test)

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

Secondary outcomes

  1. Quality of Life (SF-36)

    Time frame: Baseline, 1 month, 6 month, 12 month

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: FITS

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Nov 5, 2008
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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