StrokeNCT07039305
Physical Capacity Building for Chronic Stroke
A study testing Physical capacity training for chronic stroke - building aerobic capacity and muscle strength in people with Stroke and Post-stroke Depression, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Post-stroke Depression
- What is being tested?
- Physical capacity training for chronic stroke - building aerobic capacity and muscle strength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Ryan E Ross, Ph.D., 843-792-3477, rossre@musc.edu
Ryan E Ross, Ph.D.
About this study
Official title: Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?
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.
Read the 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
- Being tested
- Physical capacity training for chronic stroke - building aerobic capacity and muscle strength
- Keywords
- Depression, Exercise, Stroke, Stroke Recovery
- Medical subject headings
- Stroke, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical capacity training for chronic stroke - building aerobic capacity and muscle strengthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical capacity training for chronic stroke - building aerobic capacity and muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
Distance walked in six minutes.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Peak aerobic capacity
Peak aerobic capacity will be determined from a standardized cardiopulmonary exercise test and collection of expired gases.
Measured: From enrollment to the end of treatment at 12 weeks
Inventory of Psychosocial Functioning
The Inventory of Psychosocial Functioning is an 80-item measure that assesses perceived frequency of function across multiple domains of life including romantic relationships, family other than spouse/partner, work, friendships and socializing, parenting, education, and self-care.
Measured: From enrollment to the end of treatment at 12 weeks
Self-selected walking speed
Self-selected walking speed will be assessed on an instrumented mat that measures spatiotemporal characteristics of walking.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start5 Aug 2025
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ryan Ross, Medical University of South Carolina
- Investigators
- Ryan Ross, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039305
- Sponsor's protocol ID
- Pro00140518
- Other IDs
- R01HD114673
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, physical function, psychosocial function, and physiological data will be collected. Study data will be captured in a secure electronic data capture system and submitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) after all 18 HIPAA identifiers have been removed. The original dataset will be preserved at the Principal Investigator's institution. The sample informed consent, protocol, data collection forms, standardized assessment forms, data dictionary, and code book will be available in NICHD-DASH. We will use the DASH Codebook to guide our submission of variable-level metadata. The DASH codebook is a templated data dictionary, and will include details of Common Data Elements, definitions, and standards used for data collection and sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?
- ClinicalTrials.gov ID
- NCT07039305
- Acronym / sponsor ID
- Pro00140518
- Conditions
- Stroke, Post-stroke Depression
- Keywords
- Depression, Exercise, Stroke, Stroke Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical capacity training | Experimental | Behavioral: Physical capacity training for chronic stroke - building aerobic capacity and muscle strengthPhysical 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical capacity training for chronic stroke - building aerobic capacity and muscle strengthThe 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. | Behavioural | Physical capacity training |
Primary outcome
Six-minute walk test
Time frame: From enrollment to the end of treatment at 12 weeks
Distance walked in six minutes.
Stroke Impact Scale
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Hamilton Depression Rating Scale - 17
Time frame: From enrollment to the end of treatment at 12 weeks
The Hamilton Depression Rating Scale interview contains 17 items that assess the severity and frequency of depressive symptoms over the previous week.
3 secondary outcomes
Peak aerobic capacity
Time frame: From enrollment to the end of treatment at 12 weeks
Inventory of Psychosocial Functioning
Time frame: From enrollment to the end of treatment at 12 weeks
Self-selected walking speed
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. Demographic, physical function, psychosocial function, and physiological data will be collected. Study data will be captured in a secure electronic data capture system and submitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) after all 18 HIPAA identifiers have been removed. The original dataset will be preserved at the Principal Investigator's institution. The sample informed consent, protocol, data collection forms, standardized assessment forms, data dictionary, and code book will be available in NICHD-DASH. We will use the DASH Codebook to guide our submission of variable-level metadata. The DASH codebook is a templated data dictionary, and will include details of Common Data Elements, definitions, and standards used for data collection and sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Ross principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical capacity training for chronic stroke - building aerobic capacity and muscle strength in people with Stroke and Post-stroke Depression, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan E Ross, Ph.D. (843-792-3477, rossre@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.