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Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03479632
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic walking program
  • Behavioral: Standard physical therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Actual Study Start Date :
Mar 5, 2018
Anticipated Primary Completion Date :
Dec 5, 2019
Anticipated Study Completion Date :
Mar 5, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Resting Heart Rate [Change from Baseline to Week 8]

Secondary Outcome Measures

  1. Resting blood pressure [Change from Baseline to Week 8]

  2. Change in vital capacity (VC) [Change from Baseline to Week 8]

  3. Change in forced vital capacity (FVC) [Change from Baseline to Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT03479632
Other Study ID Numbers:
  • STUDY00140799
First Posted:
Mar 27, 2018
Last Update Posted:
Mar 8, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 8, 2019