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Behavioral Intervention

Diet for Stroke (EMPOWER Trial)

N/A

Waitlist Available

Led By Chris M Gregory, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 15 weeks

Awards & highlights

EMPOWER Trial Summary

"This trial aims to see if a 15-week lifestyle management program can help improve physical and psychosocial issues in Veterans who have had a stroke, similar to the benefits seen in weight loss interventions for

Who is the study for?

This trial is for Veterans who have experienced a stroke and are looking to lose weight. Participants should be interested in improving their physical and psychosocial health through a lifestyle management program combined with exercise training.Check my eligibility

What is being tested?

The study is testing the effectiveness of a 15-week FOCUS-15 Lifestyle Management Program paired with exercise training, specifically designed for individuals recovering from a stroke, aiming to enhance their physical function and overall well-being.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include muscle soreness or fatigue due to exercise training. The lifestyle program itself is unlikely to cause direct side effects but could involve changes in diet or activity that require adjustment.

EMPOWER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in distance walk in 6 minute Walk Test

Secondary outcome measures

Change in daily step activity

Change in score of Inventory of Psychosocial Functioning (IPF)

Change in score of Sheehan Disability Scale (SDS)

+1 more

Other outcome measures

Change in blood lipid profile

Change in body composition in Dual-energy x-ray absorptiometry

EMPOWER Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

exercise training

Group II: Diet + ExerciseExperimental Treatment2 Interventions

15 week weight management program + exercise training

Group III: DietExperimental Treatment1 Intervention

15 week weight management program

Group IV: ControlActive Control1 Intervention

waitlist control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Training

2011

Completed Phase 3

~1440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,330 Total Patients Enrolled

83 Trials studying Stroke

6,619 Patients Enrolled for Stroke

Chris M Gregory, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC

2 Previous Clinical Trials

79 Total Patients Enrolled

2 Trials studying Stroke

79 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria for participation in this research endeavor?

"To be eligible for participation, individuals must have experienced a cerebrovascular accident and fall between the ages of 40 and 80. This trial aims to enroll precisely 99 suitable candidates."

Answered by AI

Can individuals who have reached the age of 70 participate in this research study?

"Enrollment for this research study is targeting individuals above 40 years and below 80 years of age."

Answered by AI

Is the current investigation open for participant enrollment?

"Information available on clinicaltrials.gov states that this particular study is not actively seeking new participants. Originally shared on April 1st, 2024, with the most recent update on March 13th, 2024. Despite its closed recruitment status, there are currently 1349 other ongoing studies welcoming patient enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weight Loss and ExeRcise

2024. "Weight Loss and ExeRcise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06322030.