Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
27 апреля 2026 г. обновлено: Eduardo Lusa Cadore, Federal University of Rio Grande do Sul
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
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.
Обзор исследования
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
180
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Eduardo L Cadore, PhD
- Номер телефона: +555191193651
- Электронная почта: edcadore@yahoo.com.br
Места учебы
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Porto Alegre, Бразилия, 91350-200
- Рекрутинг
- Hospital Conceição
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Контакт:
- Eduarda Blanco Rambo, Me
- Номер телефона: 5551999079773
- Электронная почта: eduardarambo@gmail.com
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 90690-200
- Еще не набирают
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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Контакт:
- Eduardo L Cadore, PhD
- Номер телефона: +555191193651
- Электронная почта: edcadore@yahoo.com.br
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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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Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Multicomponent Training
Multicomponent exercise
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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 have access to online materials, including videos demonstrating each exercise, and will attend a pre-scheduled in-person session at Hospital Conceição in Porto Alegre to address any questions.
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Без вмешательства: Control
Patients randomized to the control group will receive general health guidance and instructions to continue with their usual care.
To monitor participants in both groups over time, monthly contacts will be made via phone or messaging app.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gait ability
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
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From enrollment and at 4, 12, 24 and 48 weeks
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Hand grip strength
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015).
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From enrollment and at 4, 12, 24 and 48 weeks
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SPPB Battery
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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SPPB tests: the five-times sit-to-stand test from a standard chair, 4-meter gait speed test, and balance tests in bipodal, semi-tandem, and tandem positions.
(Izquierdo, 2019)
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From enrollment and at 4, 12, 24 and 48 weeks
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Peak power on seat to standing movement
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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using a linear displacement transducer (encoder) during the three-times sit-to-stand test from a standard chair.
The participant will start seated, with their hands resting on their knees, and the encoder will be attached to the right wrist using a Velcro strap.
At the command "go," the participant will be instructed to stand up from the chair as quickly as possible and sit back down, repeating the movement three times.
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From enrollment and at 4, 12, 24 and 48 weeks
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number of hospitalizations
Временное ограничение: From enrollment and at the end of the study, in 48 weeks
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Standardized questionnaire
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From enrollment and at the end of the study, in 48 weeks
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Treatment toxicity
Временное ограничение: From enrollment and at the end of the study, in 48 weeks
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NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022).
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From enrollment and at the end of the study, in 48 weeks
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Mortality rate
Временное ограничение: From enrollment and at the end of the study, in 48 weeks
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Standardized questionnaire
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From enrollment and at the end of the study, in 48 weeks
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Number of falls
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Standardized questionnaire
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From enrollment and at 4, 12, 24 and 48 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical activity level
Временное ограничение: From enrollment and at the end of the study, in 48 weeks
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Physical activity level will be assessed using the Baecke Physical Activity Questionnaire (Simões, 2009), which refers to the 12 months prior to the study and is divided into questions related to daily living activities, sports activities, and leisure activities.
Participants will be classified as low physical activity (≤ 9.11 points), moderately active (9.12 to 16.17 points), or highly active (≥ 16.18 points).
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From enrollment and at the end of the study, in 48 weeks
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Vastus lateralis muscle thickness
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus lateralis of the participants' right leg, following the recommendations of Pinto et al. (2015).
Three images of the vastus lateralis will be collected at 30% of the distance from the lateral femoral epicondyle to the greater trochanter, along the patella.
A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
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From enrollment and at 4, 12, 24 and 48 weeks
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Vastus intermedius muscle thickness
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus intermedius of the participants' right leg, following the recommendations of Pinto et al. (2015).
Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella.
A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
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From enrollment and at 4, 12, 24 and 48 weeks
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Rectus femoralis muscle thickness
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the rectus femoralis of the participants' right leg, following the recommendations of Pinto et al. (2015).
Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella.
A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
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From enrollment and at 4, 12, 24 and 48 weeks
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Quality of Life Questionnarie
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Will be assessed using the Nottingham Health Profile (NHP), which contains 38 items related to overall quality of life and produces a score ranging from 0 (best quality of life) to 38 (worst quality of life) (Teixeira-Salmela et al., 2004).
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From enrollment and at 4, 12, 24 and 48 weeks
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Fatigue related symptons
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
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From enrollment and at 4, 12, 24 and 48 weeks
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Sleep quality
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)
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From enrollment and at 4, 12, 24 and 48 weeks
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Disease prognosis
Временное ограничение: From enrollment and at 4, 12, 24 and 48 weeks
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Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
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From enrollment and at 4, 12, 24 and 48 weeks
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sociodemographic characteristics
Временное ограничение: At the enrollment
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Standardized questionnaire
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At the enrollment
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Comorbidities
Временное ограничение: At the enrollment
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Standardized questionnaire
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At the enrollment
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Stage of the tumor
Временное ограничение: At the enrollment
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Standardized questionnaire
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At the enrollment
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Type of tumor
Временное ограничение: At the enrollment
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Standardized questionnaire
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At the enrollment
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Adherence to the exercise program
Временное ограничение: After 4, 12, 24 and 48 weeks of intervention
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Exercise adherence will be assessed through monitoring of training logs.
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After 4, 12, 24 and 48 weeks of intervention
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Total body mass
Временное ограничение: From enrollment and at the end of the study, in 48 weeks
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Will be measured using a digital scale
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From enrollment and at the end of the study, in 48 weeks
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Body height
Временное ограничение: From enrollment and at the end of the study, at 48 weeks
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Will be measured using a measuring tape with 1 mm resolution.
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From enrollment and at the end of the study, at 48 weeks
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Waist circunference
Временное ограничение: From enrollment and at the end of the study, at 48 weeks
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Will be measured using a measuring tape with 1 mm resolution.
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From enrollment and at the end of the study, at 48 weeks
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Nutritional assessment
Временное ограничение: From enrollment and at the end of the study, at 48 weeks
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Nutritional status will be evaluated using a three-day dietary recall.
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From enrollment and at the end of the study, at 48 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
2 марта 2026 г.
Первичное завершение (Оцененный)
1 марта 2027 г.
Завершение исследования (Оцененный)
1 июня 2027 г.
Даты регистрации исследования
Первый отправленный
27 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
27 апреля 2026 г.
Первый опубликованный (Действительный)
4 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 апреля 2026 г.
Последняя проверка
1 октября 2025 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- URioGrandeCancer
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Data will be provided only upon request, after the study is completed and published in a scientific journal.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .