Набор скоро начнётся NCT06737692

Effects of Aerobic and Resistance Exercise Training in Individuals with Cancer Cachexia

Без фазы С лечением Cancer Cachexia (CC)

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.
Кому может быть актуально: Состояния в реестре: Cancer Cachexia (CC). Базовые параметры: 18 лет — 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: Turkey (Türkiye)
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

Investigation of the Effects of Aerobic and Resistance Exercise Training in Individuals with Gastrointestinal Cancer and Cachexia: Randomized Controlled Single-Blind Study

Обзор

This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care. A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group. Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted: Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30. The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks. The intensity will be progressively adjusted based on the individual's perceived exertion.

Подробное описание

Cancer cachexia is a multifactorial syndrome characterized by progressive functional impairment and loss of skeletal muscle mass, which does not improve with nutritional support. This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.

A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.

The study will be single-blind, meaning the outcome assessor will not know which group the participants belong to.

Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:

Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.

The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.

Supervised Aerobic Exercises: Conducted every two weeks, three days a week. Supervised Resistance Exercises: Conducted every two weeks on consecutive days. On weeks without supervised exercises, participants will follow a home exercise program that includes breathing exercises, walking for 20-30 minutes, and resistance exercises.

The supervised aerobic exercises will consist of 20 minutes on a treadmill at a heart rate corresponding to 55-75% of the Karvonen formula. Warm-up and cool-down will be performed at 30-40% of the Karvonen heart rate for 5 minutes.

Resistance training will involve 12 different exercises targeting major muscle groups, using body weight and resistance bands, at an effort level of 5-7 on the Borg scale, with 8-12 repetitions and 1-3 sets.

The intensity will be progressively adjusted based on the individual's perceived exertion.

Вмешательства

Другое Exercise
Supervised Aerobic Exercises: Conducted every two weeks, three days a week (on days 11-13 post-systemic treatment). The supervised aerobic exercises will consist of 20 minutes on a treadmill at a heart rate corresponding to 55-75% of the Karvonen formula. Warm-up and cool-down will be performed at 30-40% of the Karvonen heart rate for 5 minutes. Supervised Resistance Exercises: Conducted every two weeks on consecutive days (days 11 and 13 post-systemic treatment). Resistance training will invo

Первичные конечные точки

Evaluation of Demographic and Clinical Information [Срок оценки: At baseline and after 12 weeks of exercise training]
Weight Assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Height Assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Body Mass Index Assessment Body Mass Index Assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Muscle Strength [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Lower Extremity Performance [Срок оценки: At baseline and after 12 weeks of exercise training]
Sarcopenia Assessments [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Muscle and Fat Mass [Срок оценки: At baseline and after 12 weeks of exercise training]
Mobility, balance and performance assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Functional Exercise Capacity [Срок оценки: At baseline and after 12 weeks of exercise training]

Вторичные конечные точки (5)

Performance Assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Evaluation of Symptoms [Срок оценки: At baseline and after 12 weeks of exercise training]
Frailty Assessment [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Cancer-Related Fatigue [Срок оценки: At baseline and after 12 weeks of exercise training]
Assessment of Quality of Life [Срок оценки: At baseline and after 12 weeks of exercise training]

Критерии участия

Критерии включения

Stage III-IV gastrointestinal cancer diagnosis
Age 18-65
Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery,
Karnofsky performance score 80 and above,
Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (>5% weight loss in the last 6 months or >2% weight loss in patients with BMI less than 20 kg/m2 or >2% weight loss in sarcopenic individuals)