N/A
N=20
Task-oriented Training for Stroke: Impact on Function Mobility
Cerebrovascular Accident · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01322607 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Apr 2016
Primary outcome: Primary: Economy of Gait — 13.44; 12.67 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-intensity Treadmill Exercise (Behavioral); Low-intensity Lifestyle Intervention (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Economy of Gait |
13.44; 12.67 | — |
| SECONDARY Muscular Strength |
151.82; 113.33; 101.36; 70.0; 491.82; 463.33 | — |
| SECONDARY Muscular Endurance |
67.55; 67.22; 41.63; 40.10 | — |
| SECONDARY Balance |
17.01; 14.22 | — |
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01322607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.