Physical Capacity Building for Chronic Stroke
Recruiting · NCT07039305 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
Physical capacity training for chronic stroke - building aerobic capacity and muscle strength
What this trial is about
Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. Investigators believe that individuals who have had a stroke need to be treated similarly. Investigators will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-80
- A diagnosis of stroke at least 6 months prior
- Residual paresis in the lower extremity (Fugl-Meyer lower extremity \[LE\] motor score \<34)
- Ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-1.0 m/s
- Ability to follow instructions, complete cognitive testing and to communicate exertion, pain and distress
- No antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication)
- HDRS17 question #3 and PHQ-9 question #9 regarding suicide ≤ 2
- Provision of informed consent.
- In addition, depressed subjects will screen for probable major depressive disorder (Patient Health Questionnaire-9 ≥ 10) and be diagnosed using the Structured Clinical Interview for Depression (SCID) according to the DSM-5.
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
- Attempt of suicide in the last 2 years or suicidal risk assessed by depression screening
- Current enrollment in a rehabilitation trial to enhance motor, cognitive and or psychosocial recovery
- Severe cognitive impairment (MoCA score ≤15)
- Moderate to severe neglect that precludes cognitive testing
- For brain stimulation procedures only:
- Electronic or metallic implants
- History of seizures
- Women of child bearing potential
Where it is running
1 location listed across 1 US state.
- Medical University of South Carolina - Charleston, South Carolina, United States