NCT07039305Recruiting
Physical Capacity Building for Chronic Stroke
Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 5 Aug 2025
- Primary completion date
- Jul 2029
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Stroke
- NCT number
- NCT07039305
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 5 Aug 2025 to the primary completion date, Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Electronic or metallic implants
Other illness
- Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
- Dementia
- 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
- Severe cognitive impairment (MoCA score ≤15)
- History of seizures
Other
- Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
- Life expectancy \<1 yr
- 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
- Moderate to severe neglect that precludes cognitive testing
- For brain stimulation procedures only:
- Women of child bearing potential
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.