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New study tests diet and exercise combo to boost mobility in stroke survivors

NCT ID NCT06322030

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a 15-week lifestyle program combining weight management and exercise can improve walking and daily function in obese veterans who had a stroke at least six months ago. Researchers will measure changes in walking distance, daily steps, and overall recovery. The goal is to see if these lifestyle changes can ease common physical and emotional challenges after a stroke.

What this could mean

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

Active substance
FOCUS-15 Lifestyle Management Program (diet and exercise training)
What this could lead to
If successful, this program could offer a practical way to improve walking ability and daily life for obese stroke survivors.
What could go wrong
This is a small, early-stage study with only 99 participants, so results may not apply to all stroke survivors. The program requires significant commitment, and not everyone may benefit.

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 99 people

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

Started

May 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

40 to 80 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: * A diagnosis of stroke at least 6 months prior * BMI \> 30 kg/m2 * Residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) * Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress * Provision of informed consent * Individuals who meet inclusion criteria must complete an exercise tolerance test and be cleared for participation by the study cardiologist Exclusion Criteria: * Unable to ambulate at least 150 feet or experienced intermittent claudication while walking * Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's * Dementia * Life expectancy \<1 yr * History of DVT or pulmonary embolism within 6 months * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest * Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery

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Conditions

The condition(s) this trial relates to.

Obesity stroke disorder Weight Loss

As listed by the trial registrant

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

Stroke

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

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    RECRUITING

    Charleston, South Carolina, 29401-5703, United States

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