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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01322607
First received: March 22, 2011
Last updated: March 7, 2016
Last verified: March 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Economy of Gait [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.


Secondary Outcome Measures:
  • Muscular Strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.

  • Muscular Endurance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.

  • Balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).


Enrollment: 20
Study Start Date: July 2011
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 Program
High-intensity treadmill-based exercise
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program
Arm 2: Low-Intensity Program
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   (Adult, Senior)
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,
    • 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.
  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
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Alyssa D Stookey, PhD MS Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01322607     History of Changes
Other Study ID Numbers: O7194-W 
Study First Received: March 22, 2011
Results First Received: November 23, 2015
Last Updated: March 7, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Exercise
Rehabilitation
Stroke

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

ClinicalTrials.gov processed this record on December 09, 2016