Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
27 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Eduardo L Cadore, PhD
- Número de teléfono: +555191193651
- Correo electrónico: edcadore@yahoo.com.br
Ubicaciones de estudio
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Porto Alegre, Brasil, 91350-200
- Reclutamiento
- Hospital Conceição
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Contacto:
- Eduarda Blanco Rambo, Me
- Número de teléfono: 5551999079773
- Correo electrónico: eduardarambo@gmail.com
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90690-200
- Aún no reclutando
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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Contacto:
- Eduardo L Cadore, PhD
- Número de teléfono: +555191193651
- Correo electrónico: edcadore@yahoo.com.br
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gait ability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity level
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sociodemographic characteristics
Periodo de tiempo: At the enrollment
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Standardized questionnaire
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At the enrollment
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Comorbidities
Periodo de tiempo: At the enrollment
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Standardized questionnaire
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At the enrollment
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Stage of the tumor
Periodo de tiempo: At the enrollment
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Standardized questionnaire
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At the enrollment
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Type of tumor
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de marzo de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de octubre de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- URioGrandeCancer
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data will be provided only upon request, after the study is completed and published in a scientific journal.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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