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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
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 19, 2018
Last Updated
March 7, 2019
Sponsor
University of Kansas Medical Center
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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

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