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Task-oriented Training for Stroke: Impact on Function Mobility (TOTS)

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VA Office of Research and Development

Status

Completed

Conditions

Cerebrovascular Accident
Stroke

Treatments

Behavioral: Low-intensity Lifestyle Intervention
Behavioral: High-intensity Treadmill Exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01322607
O7194-W

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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,
    • Peripheral Arterial Obstructive Disease 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 Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview.

  • Pregnancy.

Trial design

20 participants in 2 patient groups

Arm 1: High-Intensity Program
Other group
Description:
High-intensity treadmill-based exercise
Treatment:
Behavioral: High-intensity Treadmill Exercise
Arm 2: Low-Intensity Program
Other group
Description:
Low-intensity lifestyle intervention (group exercise)
Treatment:
Behavioral: Low-intensity Lifestyle Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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