No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
35 – 85
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
130 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for people who have had a stroke at least 6 months ago and are overweight. Participants will engage in different weight loss approaches to see how they affect physical and mental well-being.
Are You a Good Fit for This Trial?
Rules you outDementiaMajor head traumaSevere arthritisHistory of seizures
You may be able to join if
I am between 35 and 85 years old.
I had a stroke at least 6 months ago.
I have difficulty moving my lower body.
I can walk without help at a speed of 0.2-0.8 m/s.
I have a body mass index (BMI) over 25.
I can give my informed consent.
You may not be able to join if
I could not walk at least 150 feet before my stroke.
I have heart problems like heart failure or severe arrhythmias.
I have chronic lung disease or need oxygen.
I have a history of other neurological disorders.
I have major vision problems or am legally blind.
I have a severe mental health disorder.
I expect to live less than a year.
I have uncontrolled diabetes or severe high blood pressure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The prevalence of obesity among U.S. adults is \~40% and is projected to climb. It is well documented that obesity is associated with increased levels of disability as well as risk for numerous adverse health-related outcomes; including occurrence of stroke and all-cause mortality. Obesity is highly prevalent in stroke survivors (\~30-45% of stroke survivors have BMI\>30) and is associated with re…
The prevalence of obesity among U.S. adults is \~40% and is projected to climb. It is well documented that obesity is associated with increased levels of disability as well as risk for numerous adverse health-related outcomes; including occurrence of stroke and all-cause mortality. Obesity is highly prevalent in stroke survivors (\~30-45% of stroke survivors have BMI\>30) and is associated with reductions in physical function and increased disability. Furthermore, neurological sequelae following stroke result in a myriad of residual impairments that contribute to significant reductions in physical activity, which further increase the risk for obesity. The alarmingly high (and increasing) rates of obesity amongst stroke survivors represents an area of critical clinical need and, despite an abundance of information regarding weight loss approaches in neurologically healthy individuals, there is a lack of information regarding the impact of intentional weight loss on overweight and obese survivors of stroke. Thus, the purpose of this study it investigate the effect of varying weight loss approaches on physical function and psychosocial outcomes in chronic stroke survivors.
Trial Locations
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Eligibility Criteria
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 tha…
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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