Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)

Официальное название

Impact of Prehabilitation in Oncology Via Exercise- Esophageal

Обзор

The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise and nutrition intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise and nutrition before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups. The main questions of this trials are: * Is exercise and nutrition supplementation before surgery for esophageal cancer feasible and acceptable to patients? * How does exercise and nutrition supplementation before surgery change physical function and psychosocial health? * What are important pre-surgical needs for adults with esophageal cancer?

Вмешательства

• Поведенческое Exercise and Nutrition
  The exercise and nutrition intervention will last up to 8 weeks and will include: * 3-5 times per week of resistance training and 3-5 times per week of aerobic training. The prescribed exercise will be personalized based on the participant's baseline functionality. * Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
• Поведенческое Usual Care Group
  The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.

Первичные конечные точки

• Acceptability of Intervention [Срок оценки: From enrollment through surgical admission, up to 8 weeks]
• Adherence to Intervention [Срок оценки: From enrollment through surgical admission, up to 8 weeks]
• Feasibility of Intervention [Срок оценки: From enrollment through surgical admission, up to 8 weeks]

Вторичные конечные точки (12)

• Six-minute walk test (6MWT) [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• 2-Minute Step Test [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• 30-second chair stand test (30CST) [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Timed-Up-and-Go (TUG) test [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Frail Scale [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Handgrip assessment [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Short Physical Performance Battery (SPPB) [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Actigraph accelerometry [Срок оценки: Baseline, 2 Weeks post esophagectomy, and 4 Months post esophagectomy]
• SARC-F Sarcopenia scale [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Carbon Monoxide (CO) assessment [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Edmonton Frail Scale (EDS) [Срок оценки: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy]
• Demographics [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Men and women, age ≥ 18 years old
• Diagnosed with esophageal cancer
• Identified as esophagectomy surgery candidates at Hillman Cancer Center, UPMC Shadyside, or UPMC Passavant
• ≥ 2 weeks until scheduled esophagectomy
• ECOG Performance Status Scale score of ≤ 2
• Ability to provide written informed consent
• Ability to understand, speak, and read English.

Критерии исключения

• Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
• Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
• Receiving non-esophagectomy related chemotherapy and/or radiotherapy
• Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse

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 · 1 центр

• UPMC Hillman Cancer Center — Pittsburgh

Идентификаторы

NCT: NCT06872515 · STUDY24120028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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