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Status unknownNCT03479632Updated Mar 8, 2019

Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

An interventional study of Aerobic walking program and Standard physical therapy in Stroke, sponsored by University of Kansas Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Active comparator
    Control Group

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

    Behavioral: Standard physical therapy

Interventions

  • BehavioralAerobic walking program

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

  • BehavioralStandard physical therapy

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

05

What researchers measure

Primary outcomes

  1. Resting Heart Rate

    Time frame: Change from Baseline to Week 8

Secondary outcomes

  1. Resting blood pressure

    Time frame: Change from Baseline to Week 8

  2. Change in vital capacity (VC)

    Time frame: Change from Baseline to Week 8

  3. Change in forced vital capacity (FVC)

    Time frame: Change from Baseline to Week 8

06

Study locations

1 of 1 sites recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT03479632
Lead sponsor
University of Kansas Medical Center
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Mar 5, 2018
Primary completion
Dec 5, 2019 (estimated)
Completion
Mar 5, 2020 (estimated)
Last update
Mar 8, 2019

Study contacts

Abdulfattah Alqahtani
Contact
aalqahtani@kumc.edu
832-228-8799
Wen Liu
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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