Physical Capacity Building for Chronic Stroke

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Physical capacity training for chronic stroke - building aerobic capacity and muscle strength
  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% hear

Первичные конечные точки

• Six-minute walk test [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Stroke Impact Scale [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Hamilton Depression Rating Scale - 17 [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (3)

• Peak aerobic capacity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Inventory of Psychosocial Functioning [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Self-selected walking speed [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07039305 · Pro00140518 · R01HD114673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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