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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03479632
Other study ID # STUDY00140799
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 5, 2018
Est. completion date March 5, 2020

Study information

Verified date March 2019
Source University of Kansas Medical Center
Contact Abdulfattah Alqahtani
Phone 832-228-8799
Email aalqahtani@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 5, 2020
Est. primary completion date December 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting Heart Rate Change from Baseline to Week 8
Secondary Resting blood pressure Change from Baseline to Week 8
Secondary Change in vital capacity (VC) Change from Baseline to Week 8
Secondary Change in forced vital capacity (FVC) Change from Baseline to Week 8
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