Physical Capacity Building for Chronic Stroke
NCT07039305
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
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
Locations1 site
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NCT07039305