Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

Not Applicable

• Conditions: Stroke
• Interventions: Behavioral: Standard physical therapy; Behavioral: Aerobic walking program

• Registration Number: NCT03479632
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08
• Primary Completion: 2019-12-05
• Study Completion: 2020-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard physical therapy	The control group will receive standard physical therapy (PT).
Intervention Group	Aerobic walking program	The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.

Primary Outcome Measures

Name	Time	Method
Resting Heart Rate	Change from Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Change in vital capacity (VC)	Change from Baseline to Week 8
Resting blood pressure	Change from Baseline to Week 8
Change in forced vital capacity (FVC)	Change from Baseline to Week 8

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States