RightFit
RecruitingNot applicable

Physical Capacity Building for Chronic Stroke

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Study sites (1)

SC