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Weight Loss and Exercise for Stroke Survivors (EMP Trial)
N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 35-85
Residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights
EMP Trial Summary
This trial looks at how different weight loss approaches affect physical functioning & psychological health in stroke survivors, who are at high risk of obesity.
Who is the study for?
This trial is for chronic stroke survivors aged 35-85 with a BMI over 25, who can walk unassisted at certain speeds and have some lower extremity weakness. They must pass an exercise test and get clearance from the study physician. Excluded are those with severe heart conditions, visual impairments, uncontrollable high blood pressure, seizure history, other neurological issues or major health problems.Check my eligibility
What is being tested?
The EMPOWER trial is testing two weight loss approaches in overweight stroke survivors: a Lifestyle Management Program and a Post-stroke Optimization of Walking program using explosive resistance training to improve physical function and psychosocial outcomes.See study design
What are the potential side effects?
Potential side effects may include muscle soreness or injury from exercise programs. The lifestyle management could lead to changes in mood or behavior due to diet adjustments. Specific side effects will depend on individual health status.
EMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 85 years old.
Select...
I have weakness in my leg (Fugl-Meyer score <34).
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I can walk on my own without help or devices at various speeds.
EMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physical Function
Secondary outcome measures
Psychosocial Outcomes
EMP Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: DIET+ExerciseExperimental Treatment2 Interventions
As above with, the addition of supervised exercise. The investigators developed an innovative rehabilitation approach, Post-stroke Optimization of Walking using Explosive Resistance (POWER) training; a high-velocity, high-intensity lower extremity resistance training intervention that improves post-stroke muscular and locomotor function. POWER training will take place over a 12-week period (3 sessions/week) with exercises including leg press, calf raises, and jump training, all performed at high concentric velocity, as well as trials of fast walking and functional movements.
Group II: DIETExperimental Treatment1 Intervention
Focus-15 is a 15-week lifestyle change program developed and delivered by the Weight Management Center at the Medical University of South Carolina.
Group III: Wait-list ControlActive Control1 Intervention
Participants will undergo pre-, post- and follow-up testing but will not partake in any intervention during the same timeframe as those listed in the other arms. Participants will have the opportunity to be enrolled in one of the other arms once they have completed the WLC group timeframe.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,230 Total Patients Enrolled
67 Trials studying Stroke
60,021 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 35 and 85 years old.I have weakness in my leg (Fugl-Meyer score <34).I have passed an exercise test and been cleared by the study doctor to join.You are currently taking part in a study to improve movement recovery.I have diabetes with recent weight loss, coma, or frequent insulin issues.I have a history of serious heart conditions.You are not expected to live for more than 1 year.I can walk on my own without help or devices at various speeds.I have a neurological disorder, dementia, or have had a stroke.I had a stroke more than 6 months ago.I have severe arthritis or conditions that limit my movement.You are overweight for your height.My blood pressure is very high, over 200/110 mmHg.I couldn't walk 150 feet or had leg pain when walking before my stroke.I am legally blind or have severe vision problems.I have COPD or need oxygen.I have a history of seizures or am on seizure medication.You have had a serious injury to your head in the past.You have a history of serious mental health conditions like schizophrenia.I have had a blood clot in my leg or lung in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: DIET
- Group 2: DIET+Exercise
- Group 3: Wait-list Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to participate in this trial?
"Eligibility for this study necessitates that applicants have suffered a stroke and are between 35-85 years old. At the moment, there is capacity to accept approximately 30 participants."
Answered by AI
Is the age demarcation for this clinical trial above or below 75 years?
"This study has established an age limit of 85 years old, with the youngest candidate being 35 or older."
Answered by AI
Are there any openings to join this experiment at the moment?
"As indicated by clinicaltrials.gov, this medical experiment is not enrolling anymore patients; its post date was July 1st 2023 and it underwent the last edit on June 5th of the same year. However, there are currently 2179 other research studies actively seeking volunteers."
Answered by AI
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