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Идёт набор NCT07565519

Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial

Без фазы С лечением Cancer Aging

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: Multicomponent exercise.
Кому может быть актуально
Состояния в реестре: Cancer, Aging. Базовые параметры: от 60 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
Бразилия
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

Effects of a Multicomponent Exercise Program on Functional Capacity, Neuromuscular Parameters, Quality of Life, and Disease-Related Symptoms in Older Adults Undergoing Cancer Treatment: A Randomized, Controlled Clinical Trial

Обзор

This study aims to understand how a home-based exercise program can help improve strength, mobility, and quality of life in older adults receiving cancer treatment. Participants will be randomly divided into two groups: One group will follow a one-year multicomponent exercise program based on the ViviFrail model, done safely at home. The other group will continue with usual care. We will include men and women aged 60 or older treated at Hospital Conceição in Porto Alegre. Assessments will take place at the beginning and after 12, 24, and 48 weeks. We will measure walking speed, balance, muscle strength, and ask about quality of life, symptoms, and daily activity. The goal is to see whether home-based exercise can help older adults with cancer stay stronger, more independent, and feel better during treatment.

Подробное описание

The main objective of this study is to identify and compare the effects of a one-year physical exercise program based on the ViviFrail model versus usual care on functional capacity, neuromuscular parameters, quality of life, and disease-related symptoms in older adults undergoing cancer treatment.

Вмешательства

  • Поведенческое Multicomponent exercise
    Participants randomized to the intervention group will receive educational material about exercising during cancer treatment. In addition, they will receive a physical exercise passport based on the ViviFrail program (A, B, C, or D) according to their baseline assessment. The passport includes instructions and illustrations of each exercise, as well as details on the number of sets and repetitions, required equipment, and a training log. Furthermore, participants in the intervention group will h

Первичные конечные точки

  • Gait ability [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Hand grip strength [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • SPPB Battery [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Peak power on seat to standing movement [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • number of hospitalizations [Срок оценки: From enrollment and at the end of the study, in 48 weeks]
  • Treatment toxicity [Срок оценки: From enrollment and at the end of the study, in 48 weeks]
  • Mortality rate [Срок оценки: From enrollment and at the end of the study, in 48 weeks]
  • Number of falls [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
Вторичные конечные точки (8)
  • Physical activity level [Срок оценки: From enrollment and at the end of the study, in 48 weeks]
  • Vastus lateralis muscle thickness [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Vastus intermedius muscle thickness [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Rectus femoralis muscle thickness [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Quality of Life Questionnarie [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Fatigue related symptons [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Sleep quality [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]
  • Disease prognosis [Срок оценки: From enrollment and at 4, 12, 24 and 48 weeks]

Критерии участия

Inclusion Criteria: Men and women aged 60 years or older who are undergoing cancer treatment at Hospital Conceição in Porto Alegre, who have the cognitive ability to understand the exercises, are able to walk (even with assistance), and have medical clearance to participate in physical exercise will be included in the study.

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Exclusion Criteria: Participants who miss more than two assessments will be excluded.

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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
Лечение

Центры проведения

Бразилия · 2 центра
  • Escola de Educação Física Fisioterapia e Dança - UFRGS — Porto Alegre
  • Hospital Conceição — Porto Alegre

Идентификаторы

NCT: NCT07565519 · URioGrandeCancer

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗