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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01322607
First received: March 22, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Stroke
Behavioral: High-intensity Treadmill Exercise
Behavioral: Low-intensity Lifestyle Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Task-oriented Training for Stroke: Impact on Function Mobility

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Economy of Gait [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscular strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Muscular endurance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
High-intensity treadmill-based exercise
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program
Arm 2
Low-intensity lifestyle intervention (group exercise)
Behavioral: Low-intensity Lifestyle Intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322607

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Alyssa D Stookey, PhD MS Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01322607     History of Changes
Other Study ID Numbers: O7194-W
Study First Received: March 22, 2011
Last Updated: April 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
Rehabilitation
Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014