Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

NCT ID: NCT03479632

Last Updated: 2019-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2020-03-05

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.

Group Type EXPERIMENTAL

Aerobic walking program

Intervention Type BEHAVIORAL

Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.

Control Group

The control group will receive standard physical therapy (PT).

Group Type ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type BEHAVIORAL

Participants will receive standard care they normally would after a stroke.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard physical therapy

Participants will receive standard care they normally would after a stroke.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen Liu

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Abdulfattah Alqahtani

Role: CONTACT

832-228-8799

Other Identifiers

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STUDY00140799

Identifier Type: -

Identifier Source: org_study_id

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