Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
NCT Number: NCT07039305
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
For brain stimulation procedures only:
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Distance walked in six minutes.
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.
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Peak aerobic capacity will be determined from a standardized cardiopulmonary exercise test and collection of expired gases.
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Self-selected walking speed will be assessed on an instrumented mat that measures spatiotemporal characteristics of walking.
Time frame: From enrollment to the end of treatment at 12 weeks
Resting concentrations of serum and plasma brain-derived neurotrophic factor will be assessed through blood specimen collections.
Time frame: From enrollment to the end of treatment at 12 weeks
Corticomotor plasticity will be assessed using a non-invasive brain stimulation paradigm called paired associative stimulation (PAS). PAS utilizes a repeated and timed peripheral nerve stimulation combined with transcranial magnetic stimulation (TMS) of the contralateral motor cortex to assess corticomotor plasticity.
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?
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