Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
1 other identifier
interventional
40
1 country
1
Brief Summary
By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2018
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedMarch 8, 2019
March 1, 2019
1.8 years
March 19, 2018
March 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Resting Heart Rate
Change from Baseline to Week 8
Secondary Outcomes (3)
Resting blood pressure
Change from Baseline to Week 8
Change in vital capacity (VC)
Change from Baseline to Week 8
Change in forced vital capacity (FVC)
Change from Baseline to Week 8
Study Arms (2)
Intervention Group
EXPERIMENTALThe intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.
Control Group
ACTIVE COMPARATORThe control group will receive standard physical therapy (PT).
Interventions
Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.
Participants will receive standard care they normally would after a stroke.
Eligibility Criteria
You may qualify if:
- Independent ambulation before stroke
- Be able to understand and follow verbal commands in English
- Have physicians' approval for exercise, and be in stable medical condition
- Participant's first stroke
- Unable to walk independently according to Functional Ambulation Category (FAC) (\<2) after in-patient rehabilitation treatment
- Between 6 weeks to 5 years after stroke onset
You may not qualify if:
- Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
- Musculoskeletal disorder which prevents subjects from participating in the exercise
- Resting blood pressure more than 200/110 mm Hg
- Current or previous pulmonary diseases in the past two years
- Osteoporosis and restricted passive movement in the major joints of the lower limbs
- Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen Liu
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 27, 2018
Study Start
March 5, 2018
Primary Completion
December 5, 2019
Study Completion
March 5, 2020
Last Updated
March 8, 2019
Record last verified: 2019-03