Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic walking program
Standard physical therapy
Sponsored by
About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.
The control group will receive standard physical therapy (PT).
Outcomes
Primary Outcome Measures
Resting Heart Rate
Secondary Outcome Measures
Resting blood pressure
Change in vital capacity (VC)
Change in forced vital capacity (FVC)
Full Information
NCT ID
NCT03479632
First Posted
March 19, 2018
Last Updated
March 7, 2019
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03479632
Brief Title
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Official Title
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
December 5, 2019 (Anticipated)
Study Completion Date
March 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive standard physical therapy (PT).
Intervention Type
Behavioral
Intervention Name(s)
Aerobic walking program
Intervention Description
Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.
Intervention Type
Behavioral
Intervention Name(s)
Standard physical therapy
Intervention Description
Participants will receive standard care they normally would after a stroke.
Primary Outcome Measure Information:
Title
Resting Heart Rate
Time Frame
Change from Baseline to Week 8
Secondary Outcome Measure Information:
Title
Resting blood pressure
Time Frame
Change from Baseline to Week 8
Title
Change in vital capacity (VC)
Time Frame
Change from Baseline to Week 8
Title
Change in forced vital capacity (FVC)
Time Frame
Change from Baseline to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulfattah Alqahtani
Phone
832-228-8799
Email
aalqahtani@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
We'll reach out to this number within 24 hrs