Aphasia Physical EXercise Study: Randomized Trial

Официальное название

High-intensity Exercise in Stroke Recovery: Randomized Trial

Обзор

The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is: • Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains? Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting. Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.

Вмешательства

• Поведенческое High-intensity physical exercise
  We have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general decondit
• Поведенческое Low-intensity physical exercise
  As an active control intervention, a low-intensity non-aerobic exercise program was selected that mirrors more closely the standard-of-care physical therapy currently provided to stroke patients. This control intervention will offer the same level of participant involvement and type of interaction, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.

Первичные конечные точки

• Change on the Western Aphasia Battery (WAB) - Aphasia Quotient [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]

Вторичные конечные точки (11)

• Change on the WAB subtest scores [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R) [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Changes on Category and Letter Verbal Fluency tasks [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change on the Philadelphia Naming Test (PNT) [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Changes on the California Cognitive Assessment Battery (CCAB) [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Changes in Maximal Aerobic Capacity [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention.]
• Change on the 2-minute Step Test [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change on the 30-second chair stands [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change on the Timed Up-and-Go Test [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change on the Functional Reach Test [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]
• Change in Gait Speed [Срок оценки: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.]

Критерии участия

Критерии включения

• Aphasia following ischemic or hemorrhagic stroke
• Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
• At least 6 months from the last stroke
• Proficient in English before the stroke
• At least 8 years of education
• Between the ages of 18 and 80
• Independent with ambulation without a device (single-point cane accepted)
• Medically stable with no contraindications to participate in regular physical exercise as determined by the patients' own primary care provider or other treating provider.

Критерии исключения

• Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
• Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing
• Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• University of California, Berkeley — Berkeley
• California State University, East Bay — Hayward
• University of San Francisco — San Francisco
• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07281313 · 20243771 · R01DC022663

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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