Physical Capacity Building for Chronic Stroke

NCT07039305 | Recruiting

• 2 other identifiers: Pro00140518R01HD114673
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; Exercise; Stroke; Stroke Recovery

Outcome Measures

Primary Outcomes (3)

• Six-minute walk test

  Distance walked in six minutes.

  From enrollment to the end of treatment at 12 weeks

• Stroke Impact Scale

  The SIS assesses post-stroke recovery across eight domains - social participation, emotion, communication, memory, mobility, strength, hand function, and activities of daily living - as well as subjective extent of overall recovery.

  From enrollment to the end of treatment at 12 weeks

• Hamilton Depression Rating Scale - 17

  The Hamilton Depression Rating Scale interview contains 17 items that assess the severity and frequency of depressive symptoms over the previous week.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• Peak aerobic capacity

  From enrollment to the end of treatment at 12 weeks

• Inventory of Psychosocial Functioning

  From enrollment to the end of treatment at 12 weeks

• Self-selected walking speed

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (2)

• Brain-derived neurotrophic factor

  From enrollment to the end of treatment at 12 weeks

• Corticomotor plasticity

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Physical capacity training

EXPERIMENTAL

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.

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

Interventions

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

Physical capacity training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Depression; Motor Activity

Interventions

Muscle Strength

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ryan Ross

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan E Ross, Ph.D.

CONTACT

843-792-3477; rossre@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study team will submit processed and cleaned data to DASH as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. Data will be preserved for as long as possible within the repository's data storage and retention policies.
• Access Criteria: Prior to submission of any shared data to DASH, the Medical University of South Carolina Institutional Review Board will certify that our plan for data sharing is consistent with our informed consent procedures and does not unduly increase the risk of participants being identified. Study data will be shared with controlled access in DASH for general research use, as allowed by the participant's informed consent and the Institutional Certification.

Locations

US (1)