Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Building physical capacity after chronic stroke

Official title: Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?

Run by Medical University of South Carolina · NCT07039305 · Data updated 2026-11-12

This 12-week modified cardiac rehabilitation program will try to improve physical fitness and mood in people living with chronic stroke, including those with post-stroke depression.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment76 (estimated)
SponsorMedical University of South Carolina
Academic / other
Locations1 site (Charleston, South Carolina)
StatusRecruiting
StartedAugust 5, 2025
Main results expectedJuly 2029
Study endsAugust 2029
Registry record updatedDecember 8, 2025
Trial IDNCT07039305 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–80 who had a stroke at least six months ago, have residual lower-limb weakness but can walk without assistance at slow to moderate speeds, can follow instructions, and have stable psychotropic medication doses are ideal candidates.

Probably not a fit

People who cannot walk at least 150 feet, require ankle-foot orthoses during testing, have unstable medical or psychiatric conditions (including recent changes in antidepressants or high suicide risk), or have severe cognitive impairment are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program delivers a 12-week modified cardiac rehabilitation regimen combining progressive aerobic exercise and muscle-strengthening for community-dwelling survivors of stroke. Participants include adults at least six months post-stroke with residual lower-extremity weakness who can walk without assistance, and the protocol deliberately includes people with post-stroke depression. Physical outcomes (walking speed, endurance, strength) and psychosocial measures (depression, quality of life) are tracked before and after the intervention. The trial tests whether a cardiac rehabilitation model can be adapted to improve both physical and emotional recovery after chronic stroke.

Why it matters

Potential benefit: If successful, the program could improve walking capacity, strength, and mood, leading to better daily function and quality of life for chronic stroke survivors.

How similar studies have gone: Cardiac rehabilitation is proven to aid recovery after cardiac events and smaller exercise trials suggest benefit after stroke, but comprehensive modified cardiac rehab programs that include people with post-stroke depression have been little studied.

Who can join: the full rules

Show full inclusion / exclusion criteria
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's running

  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Ryan Ross — Medical University of South Carolina
  • Study coordinator: Ryan E Ross, Ph.D.
  • Email: rossre@musc.edu
  • Phone: 843-792-3477

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Deep phenotyping to explore recovery in young adults after stroke

    This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

    Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

  • Effects of natural light on stroke recovery complications

    This study tests if using natural light during rehab can help stroke patients feel less depressed and tired as they recover.

    Recruiting Copenhagen University Hospital, Rigshospitalet · Glostrup Municipality, Capital Region · NCT06922409

  • Stem cell therapy for chronic stroke recovery

    This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

    Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

  • AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

    This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

    Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

  • Web-based therapy using action observation and mirror therapy for arm weakness after stroke

    This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

    Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

  • Remote Ischaemic Conditioning for Fatigue After Stroke 2

    Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

    Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.