Phase 1
N=76
Adaptive Physical Activity for Chronic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00773370 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: 6 Minute Walk Test (6MWT) — 189; 172; 211; 170 meters — p=<0.25
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- APA-Stroke (Behavioral); Sittercise (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Test (6MWT) |
189; 172; 211; 170; 228; 167 | <0.25 |
| SECONDARY Balance as Measured by the Berg Balance Scale (BBS) |
44.8; 43.0; 46.5; 43.0; 47.6; 41.6 | .47 |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.60; 6.10; 6.76; 5.92; 7.12; 5.96 | .98 |
| SECONDARY Stroke Impact Scale (SIS) |
467; 491; 463; 576; 562; 579 | .98 |
Summary
This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group exercise program, (Sittercise) to see if APA leads to greater improvements in walking endurance, quality of life, and participation in social activities.
Eligibility Criteria
Inclusion Criteria
- evidence of stroke (ischemic or hemorrhagic) minimum 6 months prior in men or women ages 40 or older;
- residual hemiparetic gait deficits;
- already completed all conventional inpatient and outpatient physical therapy;
- ability to rise from a chair unaided and without an assistive device
Exclusion Criteria
- cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure (NYHA category II or higher);
- orthopedic, circulatory, or chronic pain conditions restricting exercise;
- active cancer; poorly controlled hypertension ( greater than 180/100 on 2 readings separated by 5 minutes rest);
- dementia;
- severe receptive or global aphasia with inability to follow 2-step commands;
- co-morbid non-stroke neurological disorder that impairs mobility (e.g. multiple sclerosis or Parkinson's);
- untreated clinical depression;
- inability to complete the "6-Minute Walk" test during baseline testing
Data sourced from ClinicalTrials.gov (NCT00773370). 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.