Physical Capacity Building for Chronic Stroke
Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?
Medical University of South Carolina
76 participants
Aug 5, 2025
INTERVENTIONAL
Conditions
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 Criteria9
- 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 Criteria15
- 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
Interventions
The general format of each exercise session includes assessment of resting heart rate (HR), blood pressure (BP), and rating of perceived exertion (RPE) followed by a 5-minute warm-up, a minimum of 30 minutes of aerobic exercise followed by 25 minutes of resistance exercise. Aerobic exercise will always include a minimum of 10 minutes of walking (overground or treadmill) at the prescribed intensity followed by cycle, arm or rowing ergometry. Sessions will begin at a target intensity of \~60% heart rate reserve (HRR) determined from the exercise tolerance test performed at baseline and calculated using Karvonen's formula. The goal will be to increase training intensity by \~5% HRR every \~3 weeks and progressed as tolerated. Resistance exercise will target all major muscle groups and include multiple sets dosed at the 10-repetition to fatigue level (\~75% of the 1-repetition maximum). Resistance exercises will be progressed with improvements in strength or as tolerated.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07039305