Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

March 7, 2019 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.
Behavioral: Aerobic walking program
Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.
Active Comparator: Control Group
The control group will receive standard physical therapy (PT).
Behavioral: Standard physical therapy
Participants will receive standard care they normally would after a stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting Heart Rate
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Resting blood pressure
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8
Change in vital capacity (VC)
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8
Change in forced vital capacity (FVC)
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Wen Liu, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Anticipated)

December 5, 2019

Study Completion (Anticipated)

March 5, 2020

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140799

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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