Phase I Randomized Controlled Trial of Functional Resistance Training in Older Cancer Survivors: The ACES Trial
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: Functional Resistance Training, Stretching, Delayed Functional Resistance Training.
- Кому может быть актуально
- Состояния в реестре: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Cancer, Functional Limitation. Базовые параметры: от 65 лет · Все.
- 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
ACES: Advancing Capacity to Integrate Exercise Into the Care of Older Cancer Survivors
Обзор
The study will assess the feasibility and preliminary efficacy of live, online supervised group functional resistance training in older cancer survivors who may have difficulty with independent functioning. The study design is a three-arm parallel group randomized controlled trial (immediate resistance training, delayed resistance training, stretching placebo) in 150 older cancer survivors. The resistance training program will be compared to two different types of common control groups: a stretching placebo group and a delayed intervention group. By using two control conditions, this study can also inform the design of future randomized trials on the selection of an appropriate control group.
Подробное описание
This study is designed to begin addressing the current gap in evidence-based exercise guidelines for older cancer survivors, many of whom are at risk for losing their functional independence. This study is a three-arm parallel group randomized feasibility trial of 16 weeks of live, online supervised group functional resistance training in older (age 65+) cancer survivors (stages I - IV, including hematological malignancies) with or at risk for a functional limitation (n=150). Participants will be randomized in a 1:1:1 ratio to one of three study arms (immediate progressive functional resistance training (PFRT) intervention, stretching placebo; or, delayed PFRT), stratified by disease stage (metastatic vs non-metastatic). For both the immediate PFRT arm and the stretching placebo, participants will attend three 45-minute live, online supervised group sessions per week for 16 weeks. The immediate PFRT arm progresses from low to moderate intensity over 16 weeks based on participant tolerance. The stretching arm will perform stretches seated in a chair and will emphasize whole body range of motion and relaxation. The delayed PFRT arm will receive educational information about healthy lifestyle behaviors and monthly check-in calls over the first 16 weeks, then will follow the same exercise protocol as the immediate PFRT arm for an additional 16 weeks, during which feasibility outcomes will be collected. All participants will undergo two assessments (baseline and post-intervention at 16 weeks), consisting of surveys and performance assessments. The primary objective is to evaluate acceptability, tolerability, and safety of live, online supervised group functional resistance training sessions, as assessed by loss-to-follow-up, permanent discontinuation (i.e., study withdrawal), attendance to exercise sessions, treatment interruption, exercise dose modification, pre-treatment dose modification, tolerability (i.e., relative dose intensity), and prevalence and attribution status of adverse events. The secondary objective is to assess preliminary effects of the intervention on physical and mental health outcomes, including objectively measured physical function (Timed Up and Go, Physical Performance Battery), patient-reported symptoms and health related quality of life (Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue, Sleep Disturbance, Depression, Physical Function, Pain Intensity, Cognition, Anxiety; EuroQoL-5 Dimensions, European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30), functional independence and disability (Nottingham Extended Activities of Daily Living, Late-Life Function and Disability Instrument), life-space mobility (Life Space Assessment), cognitive screening (Montreal Cognitive Assessment), frailty indicators (Chair Stand Test, 4-Meter Walk Test, self-reported physical activity and fatigue, and unintentional weight loss), and physical activity behaviors (Community Healthy Activities Model Program for Seniors).
Вмешательства
- Другое Functional Resistance Training
Participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks. - Другое Stretching
Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks. - Другое Delayed Functional Resistance Training
Participants will receive educational information about healthy lifestyle behaviors and receive monthly check in calls from study staff. After 16 weeks, participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks.
Первичные конечные точки
- Loss-to-Follow Up [Срок оценки: 16 weeks]
- Permanent Discontinuation [Срок оценки: 16 weeks]
- Attendance [Срок оценки: 16 weeks]
- Treatment Interruption [Срок оценки: 16 weeks]
- Dose Modification [Срок оценки: 16 weeks]
- Pre-treatment Dose Modification [Срок оценки: 16 weeks]
- Tolerability (Relative Dose Intensity) [Срок оценки: 16 weeks]
Вторичные конечные точки (12)
- Timed Up and Go (TUG) test [Срок оценки: Baseline, 16 weeks]
- Physical Performance Battery (PPB) test [Срок оценки: Baseline, 16 weeks]
- Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a [Срок оценки: Baseline, 16 weeks]
- PROMIS Sleep Disturbance Short Form 8a [Срок оценки: Baseline, 16 weeks]
- PROMIS Depression Short Form 4a [Срок оценки: Baseline, 16 weeks]
- PROMIS Physical Function Short Form 10a [Срок оценки: Baseline, 16 weeks]
- PROMIS Pain Intensity Short Form 10a [Срок оценки: Baseline, 16 weeks]
- PROMIS Cognition Short Form 8a [Срок оценки: Baseline, 16 weeks]
- PROMIS Anxiety Short Form 4a [Срок оценки: Baseline, 16 weeks]
- EuroQoL-5 Dimensions (EQ-5D) Questionnaire [Срок оценки: Baseline, 16 weeks]
- European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQC-30) [Срок оценки: Baseline, 16 weeks]
- Nottingham Scale for Extended Activities of Daily Living (NEADL) [Срок оценки: Baseline, 16 weeks]
Критерии участия
Критерии включения
- Age 65 years of age or older
- Diagnosed with stage I-IV cancer =< 5 years ago
- Completed surgery, chemotherapy, or radiation therapy > 3 months ago (concurrent maintenance therapy, such as hormone therapy for breast or prostate cancer, is permissible)
- Self-report at least one limitation in Activities of Daily Living (ADLs) OR at clinical risk of developing ADL impairment as evidenced by a 3-meter timed-up-and-go time > 13.5 seconds or 5-time chair stand time > 12 seconds
- Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed
- Currently underactive (an average of < 30 minutes of moderate-vigorous intensity exercise 3 days/week over the past four weeks)
- Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions
- Home internet sufficient for videoconferencing
Критерии исключения
- Contraindication to moderate intensity exercise
- Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise
- Cognitive impairment consistent with moderate dementia (confirmed by a Montreal Cognitive Assessment (MoCA) score < 14). Cognitive impairment consistent with early-stage dementia (a MoCA score of <20) unless a research partner (e.g., family member, caregiver, close friend) can also be consented and can assist in answering the survey questions, participating in the performance tests, or giving informed consent.
- Not fluent in English and therefore incapable of answering survey questions, following directions during exercise or performance testing, and providing informed consent in English
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
- Поддерживающая терапия
Центры проведения
США · 1 центр
- OHSU Knight Cancer Institute — Portland
Идентификаторы
NCT: NCT07606313 · STUDY00028387 · 4R33CA280996-03 · NCI-2025-02748 · STUDY00028387