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Physical Capacity Building for Chronic Stroke

RECRUITINGN/ASponsored by Medical University of South Carolina
Actively Recruiting
PhaseN/A
SponsorMedical University of South Carolina
Started2025-08-05
Est. completion2029-07
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions4

DepressionHeart DiseasePost-stroke DepressionStroke

Locations1 site

Medical University of South Carolina
Charleston, South Carolina, 29425
Ryan E Ross, Ph.D.843-792-3477rossre@musc.edu

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