Physical Capacity Building for Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Physical capacity training for chronic stroke - building aerobic capacity and muscle strength
BehavioralThe 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.
Treatment groups
76 Participants
are divided into 1 treatment groupGroup A: Physical capacity trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Six-minute walk test
Distance walked in six minutes.
Time frame
From enrollment to the end of treatment at 12 weeks2
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.
Time frame
From enrollment to the end of treatment at 12 weeks3
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.
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Peak aerobic capacity
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 weeks2
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.
Time frame
From enrollment to the end of treatment at 12 weeks3
Self-selected walking speed
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 weeksOther outcomes
1
Brain-derived neurotrophic factor
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 weeks2
Corticomotor plasticity
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.
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov