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Идёт набор NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Фаза I / Фаза II С лечением Prostate Cancer Supportive Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exercise Training Intervention, Healthy Living Education.
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Supportive Care. Базовые параметры: 40 лет — 85 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)

Обзор

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

Вмешательства

  • Поведенческое Exercise Training Intervention
    5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.
  • Поведенческое Healthy Living Education
    During the initial 12 weeks of the study, men randomized to the HLE group will receive educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

Первичные конечные точки

  • Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks [Срок оценки: Baseline, 12 weeks, and 24 weeks]
  • Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks [Срок оценки: Baseline, 12 weeks, and 24 weeks]
Вторичные конечные точки (12)
  • Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls. [Срок оценки: Baseline, 12 weeks]
  • Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls. [Срок оценки: Baseline, 12 weeks]
  • Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls. [Срок оценки: Baseline, 12 weeks]
  • Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls. [Срок оценки: Baseline, 12 weeks]
  • Change in lean body mass [Срок оценки: Baseline, 12 weeks]
  • Change in fat mass [Срок оценки: Baseline, 12 weeks]
  • Neighborhood Environment & Walkability Survey (NEWS-A) [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ) [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in physical activity assessed with Accelerometry [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in self-efficacy to navigate barriers to engaging in exercise [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in self-efficacy to walk for increasing periods of time. [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores [Срок оценки: Baseline, 12 weeks, 24 weeks]

Критерии участия

Критерии включения

  • Be diagnosed with stage II/III/IV prostate cancer
  • Be currently undergoing treatment with ADT (intermittent or prolonged)
  • Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
  • Be >40 years of age up to 85;
  • Be willing to sign an informed consent with HIPAA authorization form;
  • Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
  • Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
  • Be without any serious medical condition that precludes safe participation in an exercise program;
  • Speak English

Критерии исключения

  • Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
  • Have contraindications to exercise testing;
  • Have pre-existing overt cardiovascular disease/heart failure;
  • Active illness/infection;
  • Hemoglobin < 7.0 grams/dL
  • Platelet count < 10 x 109/L

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 2 центра
  • Richmond Veterans Affairs Medical Center — Richmond
  • Virginia Commonwealth University Massey Cancer Center — Richmond

Идентификаторы

NCT: NCT06237179 · MCC-23-20934 · HM20028583 · 1K01HL161419-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗