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New study tests weight loss and exercise combo for stroke recovery

NCT ID NCT05901675

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a structured weight loss program, with or without added exercise, can improve physical function and emotional well-being in obese veterans who have had a stroke. Researchers will enroll 130 participants aged 35-85 who had a stroke at least 6 months ago. The program uses meal replacements and dietitian support, plus exercise for some groups, to see if it helps with walking and daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lifestyle management program (dietary meal replacements and structured diet) with or without exercise
What this could lead to
If successful, this could show that combining weight loss with exercise helps stroke survivors walk better and feel better emotionally.
What could go wrong
This is a relatively small, early-stage study without a control group for the exercise component, so results may not apply to all stroke survivors. Weight loss programs can be hard to stick with long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age 35-85 2. stroke at least 6-months prior 3. residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) 4. ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s 5. body mass index (BMI) greater than 25 6. provision of informed consent. All subjects who meet criteria for training must complete an exercise tolerance test and be cleared for participation by the study physician. Exclusion Criteria: 1. unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking 2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's 3. history of COPD or oxygen dependence 4. preexisting neurological disorders, dementia or previous stroke 5. history of major head trauma 6. legal blindness or severe visual impairment 7. history of psychosis or other Axis I disorder that is primary 8. life expectancy \<1 yr 9. severe arthritis or other problems that limit passive ROM 10. history of DVT or pulmonary embolism within 6 months 11. uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions 12. severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest 13. history of seizures or currently prescribed anti-seizure medications 14. current enrollment in a clinical trial to enhance motor recovery 15. persons with child-bearing potential.

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Conditions

The condition(s) this trial relates to.

Motor Activity Obesity obesity disorder stroke disorder Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • College of Health Professions

    RECRUITING

    Charleston, South Carolina, 29425, United States

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