Physical Capacity Building for Chronic Stroke

NCT ID: NCT07039305

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2029-08-31

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.

Detailed Description

Cardiac rehabilitation is a mandated, standard-of-care treatment for patients following cardiac events (e.g., heart attack, angioplasty, cardiac bypass). Cardiac rehabilitation is designed to enhance recovery via progressive exercise and is shown to improve overall physical, cognitive and psychosocial function. Disappointingly, despite sharing common etiology and post-event risk factors, stroke is not a condition that qualifies survivors for cardiac rehabilitation and few clinical trials that have directly investigated the impact of a comprehensive modified cardiac rehabilitation program on physical and psychosocial function in chronic survivors of stroke. Moreover, depression is the most common neuropsychiatric manifestation following stroke, and subjects with post-stroke depression (PSD) are historically excluded from rehabilitation clinical trials. Consequently, data describing the effects of a cardiac rehabilitation programs on physical and psychosocial function in cohorts with PSD is lacking. The purpose of this project is to examine the effects of Physical Capacity training for ChroniC stroke - Building Aerobic capacity and Muscle Strength (PC3-BAMS), a 12-week modified cardiac rehabilitation program, on physical and psychosocial function in community-dwelling survivors of stroke with and without post-stroke depression (PSD).

Conditions

Stroke; Post-stroke Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Responsible Party

Ryan Ross

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Ross

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan E Ross, Ph.D.

Role: CONTACT

rossre@musc.edu

843-792-3477

Facility Contacts

Ryan E Ross, Ph.D.

Role: primary

rossre@musc.edu

843-792-3477

Other Identifiers

R01HD114673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00140518

Identifier Type: -

Identifier Source: org_study_id