Clinical trial NCT01322607: Task-oriented Training for Stroke: Impact on Function Mobility
Official title: Task-oriented Training for Stroke: Impact on Function Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Stroke
Keywords: Exercise
Rehabilitation
Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Economy of Gait
timeFrame: 3 months
Secondary outcomes:
measure: Muscular Strength
timeFrame: 3 months
measure: Muscular Endurance
timeFrame: 3 months
measure: Balance
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Alyssa D Stookey, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stookey AD, Macko RF, Ivey FM, Katzel LI. Evaluating Test-Retest Reliability of Fatigability in Chronic Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105895. doi: 10.1016/j.jstrokecerebrovasdis.2021.105895. Epub 2021 Jul 7.