Overview

This trial is active, not recruiting.

Conditions cerebrovascular accident, stroke
Treatments high-intensity treadmill exercise, low-intensity lifestyle intervention
Sponsor Department of Veterans Affairs
Start date July 2011
End date January 2014
Trial size 60 participants
Trial identifier NCT01322607, O7194-W

Summary

Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Other)
High-intensity treadmill-based exercise
high-intensity treadmill exercise
High-intensity treadmill walking program
(Other)
Low-intensity lifestyle intervention (group exercise)
low-intensity lifestyle intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

Primary Outcomes

Measure
Economy of Gait
time frame: 3 months

Secondary Outcomes

Measure
Muscular strength
time frame: 3 months
Muscular endurance
time frame: 3 months
Balance
time frame: 3 months

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of - unstable angina, - recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), - hemodynamically significant valvular dysfunction, - PAOD with claudication, - major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, - pulmonary or renal failure, - poorly controlled hypertension (>190/110), measured on at least two separate occasions - recent hospitalization for severe disease or surgery - severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. - Pregnancy.

Additional Information

Official title Task-oriented Training for Stroke: Impact on Function Mobility
Principal investigator Alyssa D Stookey, PhD MS
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.