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Resistance Training
Strength Training for Post-Stroke Recovery (POWER-D Trial)
Phase 2
Recruiting
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 50-70
Ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 through visit 24 (up to 12 weeks)
Awards & highlights
POWER-D Trial Summary
This trial will study if a 12 week strength training program helps treat depression and improves walking function in individuals who have had a stroke.
Who is the study for?
This trial is for individuals aged 50-70 who had a stroke within the last 5 years, can walk without help at certain speeds, and are experiencing depression. They shouldn't have made any recent changes to antidepressant medication or be on such treatments. People with uncontrolled diabetes, severe heart conditions, other major neurological disorders, or those at risk of suicide aren't eligible.Check my eligibility
What is being tested?
The study tests if a 12-week strength training program (power training) versus stretching exercises can improve walking function and alleviate depression in post-stroke patients. The goal is to develop better treatment strategies for common post-stroke issues.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include muscle soreness or injury from power training and fatigue. Stretching could cause discomfort if not done properly. Participants will be monitored for any adverse reactions.
POWER-D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 70 years old.
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I can walk on my own without help or devices at various speeds.
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I have weakness in my leg (Fugl-Meyer score <34).
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I am between 50 and 70 years old.
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I have weakness in my leg.
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I can walk on my own without help or devices at a slow to moderate pace.
POWER-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 1 through visit 24 (up to 12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 through visit 24 (up to 12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Change in Self Selected Walking Speed
POWER-D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: POWER trainingExperimental Treatment1 Intervention
high velocity strength training
Group II: StretchingActive Control1 Intervention
Upper and lower body range of motion exercises
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Power training
2021
N/A
~70
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,946 Total Patients Enrolled
40 Trials studying Depression
6,935 Patients Enrolled for Depression
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,680,305 Total Patients Enrolled
30 Trials studying Depression
15,112 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is very high, over 200/110 mmHg.You are expected to live less than one year.You have a history of severe mental illness.You have had a serious head injury in the past.I haven't started or changed any antidepressant doses in the last 4 weeks.I couldn't walk 150 feet without assistance or had pain in my legs while walking before my stroke.I have COPD or need oxygen.I have a history of neurological disorders, dementia, or stroke.I am between 50 and 70 years old.I had a stroke between 6 months and 5 years ago.I have a history of serious heart conditions.I am legally blind or have severe trouble seeing.I have severe arthritis or conditions that limit my joint movement.You are currently participating in a study to improve movement recovery.I have diabetes with recent weight loss, diabetic coma, or frequent insulin reactions.I can walk on my own without help or devices at various speeds.Your answers to questions about feeling suicidal are not too high, and you have given your permission to take part in the study.I have weakness in my leg (Fugl-Meyer score <34).I haven't started or changed any mental health meds in the last 4-6 weeks.I have a history of seizures or am on seizure medication.I have had a blood clot in my leg or lung in the past 6 months.You have tried to harm yourself in the past 2 years or have been evaluated as being at risk of harming yourself during an interview.I am between 50 and 70 years old.I have weakness in my leg.I had a stroke between 6 months and 5 years ago.I can walk on my own without help or devices at a slow to moderate pace.
Research Study Groups:
This trial has the following groups:- Group 1: POWER training
- Group 2: Stretching
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.
Depression Patient Testimony for trial: Trial Name: NCT03826771 — Phase 2
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