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Идёт набор NCT05224518

Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer

Без фазы С лечением Colorectal Cancer Fatigue Quality of Life

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: elastic band training.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Fatigue, Quality of Life. Базовые параметры: от 20 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

National Taiwan University Hospital Hsin-Chu Branch.

Обзор

The purpose of this study was to explore the 12-week effectiveness of home exercise intervention for colorectal cancer patients in improving fatigue, sleep, muscle endurance, and quality of life. A. Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients. B. Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer. C. Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer. D. Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.

Подробное описание

The study was conducted at the colon and rectal outpatient departments. A randomized controlled trial design was adopted. The participants were divided into an interventional group and a conventional therapy control group based on block randomization in a 1:1 ratio. Data were collected when patients returned to the clinic.

Вмешательства

  • Поведенческое elastic band training
    elastic band training include stretching exercises

Первичные конечные точки

  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: baseline]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 1rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 2rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 3rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 6rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 12rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Срок оценки: 24rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Срок оценки: baseline]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Срок оценки: 1rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Срок оценки: 2rd month after recruited]
Вторичные конечные точки (12)
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: baseline]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 1rd month after recruited]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 2rd month after recruited]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 3rd month after recruited]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 6rd month after recruited]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 12rd month after recruited]
  • Brief Fatigue Inventory-Taiwanese (BFI-T) [Срок оценки: 24rd month after recruited]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 1rd month after recruited]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 2rd month after recruited]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 3rd month after recruited]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 6rd month after recruited]

Критерии участия

A. Inclusion criteria

  • Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.
  • Coherent, with no mental abnormalities.
  • Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.
  • Provided informed consent.
  • No physical disabilities.

B. Exclusion criteria

  • Acute inflammation of the limbs and joints.
  • Previous abdominal surgery within 3 months.
  • Symptomatic cardiovascular events.
  • Long-term anti-depressant drug use.
  • Unilateral restrictions of the upper or lower limbs.
  • History of medium- or high-intensity exercise for more than half a year.
  • Having colostoma or ileostoma.

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
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 1 центр
  • NTU Hsin-Chu Hospital — Hsinchu

Публикации

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
  • Chen Y, Niu M, Zhang X, Qian H, Xie A, Wang X. Effects of home-based lower limb resistance training on muscle strength and functional status in stable Chronic obstructive pulmonary disease patients. J Clin Nurs. 2018 Mar;27(5-6):e1022-e1037. doi: 10.1111/jocn.14131. Epub 2018 Feb 6. PMID 29076609
  • Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. PMID 23851406
  • Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. PMID 31626055
  • Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117. PMID 31626056
  • Uster A, Ruehlin M, Mey S, Gisi D, Knols R, Imoberdorf R, Pless M, Ballmer PE. Effects of nutrition and physical exercise intervention in palliative cancer patients: A randomized controlled trial. Clin Nutr. 2018 Aug;37(4):1202-1209. doi: 10.1016/j.clnu.2017.05.027. Epub 2017 Jun 8. PMID 28651827

Идентификаторы

NCT: NCT05224518 · 110-146-E

Первоисточники (государственные реестры)

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