Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18-70

• 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.

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Ryan E Ross, Ph.D.
rossre@musc.edu
843-792-3477
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2029-08
Participants
Target number of participants: 76
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov