Recruiting

Cardiac Rehabilitation

Sponsor:

Medical University of South Carolina

Code:

NCT07039305

Conditions

Stroke

Post-stroke Depression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Physical capacity training for chronic stroke - building aerobic capacity and muscle strength

Study Details

Brief 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.

Conditions

Stroke

Post-stroke Depression

Study ID

NCT07039305

Start date

Aug 5, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

76 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physical capacity training

Physical capacity training is a comprehensive modified cardiac rehabilitation program consisting of aerobic and resistance exercise. Participants will attend a total of 36 sessions of training.

Interventions

Physical capacity training for chronic stroke - building aerobic capacity and muscle strength

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.

Primary outcome measure

  • Six-minute walk test [ Time Frame: From enrollment to the end of treatment at 12 weeks ]
  • Stroke Impact Scale [ Time Frame: From enrollment to the end of treatment at 12 weeks ]
  • Hamilton Depression Rating Scale - 17 [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts and Locations

Central contacts

Ryan E Ross, Ph.D.

843-792-3477rossre@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ryan E Ross, Ph.D.

843-792-3477rossre@musc.edu

Principal Investigator:

Ryan E Ross, Ph.D.

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Depression
  • Exercise
  • Stroke
  • Stroke Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-08.