StrokeNCT03479632
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
A study testing Aerobic walking program and Standard physical therapy in people with Stroke, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic walking program and Standard physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Stroke
- Being tested
- Aerobic walking program, Standard physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic walking programBehavioural
Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.
Standard physical therapyBehavioural
Participants will receive standard care they normally would after a stroke.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device. Receives: Behavioral: Aerobic walking program |
| Control Group | Active comparator | The control group will receive standard physical therapy (PT). Receives: Behavioral: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Heart Rate
Measured: Change from Baseline to Week 8
Secondary outcomes (3)
Resting blood pressure
Measured: Change from Baseline to Week 8
Change in vital capacity (VC)
Measured: Change from Baseline to Week 8
Change in forced vital capacity (FVC)
Measured: Change from Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start5 Mar 2018
- Primary completion5 Dec 2019 (estimated)
- Study completion5 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Liu, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479632
- Sponsor's protocol ID
- STUDY00140799
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
- ClinicalTrials.gov ID
- NCT03479632
- Acronym / sponsor ID
- STUDY00140799
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Dec 2019 (estimated)
- Study completion
- 5 Mar 2020 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Aerobic walking programThe intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device. |
| Control Group | Active comparator | Behavioral: Standard physical therapyThe control group will receive standard physical therapy (PT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic walking programParticipants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour. | Behavioural | Intervention Group |
| Standard physical therapyParticipants will receive standard care they normally would after a stroke. | Behavioural | Control Group |
Primary outcome
Resting Heart Rate
Time frame: Change from Baseline to Week 8
3 secondary outcomes
Resting blood pressure
Time frame: Change from Baseline to Week 8
Change in vital capacity (VC)
Time frame: Change from Baseline to Week 8
Change in forced vital capacity (FVC)
Time frame: Change from Baseline to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic walking program and Standard physical therapy in people with Stroke, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulfattah Alqahtani (832-228-8799, aalqahtani@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Heart Rate (time frame: Change from Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.