Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
27 avril 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Eduardo L Cadore, PhD
- Numéro de téléphone: +555191193651
- E-mail: edcadore@yahoo.com.br
Lieux d'étude
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Porto Alegre, Brésil, 91350-200
- Recrutement
- Hospital Conceição
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Contact:
- Eduarda Blanco Rambo, Me
- Numéro de téléphone: 5551999079773
- E-mail: eduardarambo@gmail.com
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90690-200
- Pas encore de recrutement
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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Contact:
- Eduardo L Cadore, PhD
- Numéro de téléphone: +555191193651
- E-mail: edcadore@yahoo.com.br
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Gait ability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical activity level
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sociodemographic characteristics
Délai: At the enrollment
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Standardized questionnaire
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At the enrollment
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Comorbidities
Délai: At the enrollment
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Standardized questionnaire
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At the enrollment
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Stage of the tumor
Délai: At the enrollment
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Standardized questionnaire
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At the enrollment
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Type of tumor
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 mars 2026
Achèvement primaire (Estimé)
1 mars 2027
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
27 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 avril 2026
Dernière vérification
1 octobre 2025
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- URioGrandeCancer
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Data will be provided only upon request, after the study is completed and published in a scientific journal.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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