Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

27 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
      • Porto Alegre, Brazilië, 91350-200
        • Werving
        • Hospital Conceição
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90690-200
        • Nog niet aan het werven
        • Escola de Educação Física Fisioterapia e Dança - UFRGS
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

-

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

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Multicomponent Training
Multicomponent exercise
Gedragsmatig: 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 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gait ability
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
From enrollment and at 4, 12, 24 and 48 weeks
Hand grip strength
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015).
From enrollment and at 4, 12, 24 and 48 weeks
SPPB Battery
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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)
From enrollment and at 4, 12, 24 and 48 weeks
Peak power on seat to standing movement
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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.
From enrollment and at 4, 12, 24 and 48 weeks
number of hospitalizations
Tijdsspanne: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
From enrollment and at the end of the study, in 48 weeks
Treatment toxicity
Tijdsspanne: From enrollment and at the end of the study, in 48 weeks
NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022).
From enrollment and at the end of the study, in 48 weeks
Mortality rate
Tijdsspanne: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
From enrollment and at the end of the study, in 48 weeks
Number of falls
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
From enrollment and at 4, 12, 24 and 48 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical activity level
Tijdsspanne: From enrollment and at the end of the study, in 48 weeks
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).
From enrollment and at the end of the study, in 48 weeks
Vastus lateralis muscle thickness
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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.
From enrollment and at 4, 12, 24 and 48 weeks
Vastus intermedius muscle thickness
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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.
From enrollment and at 4, 12, 24 and 48 weeks
Rectus femoralis muscle thickness
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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.
From enrollment and at 4, 12, 24 and 48 weeks
Quality of Life Questionnarie
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
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).
From enrollment and at 4, 12, 24 and 48 weeks
Fatigue related symptons
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
From enrollment and at 4, 12, 24 and 48 weeks
Sleep quality
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)
From enrollment and at 4, 12, 24 and 48 weeks
Disease prognosis
Tijdsspanne: From enrollment and at 4, 12, 24 and 48 weeks
Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
From enrollment and at 4, 12, 24 and 48 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sociodemographic characteristics
Tijdsspanne: At the enrollment
Standardized questionnaire
At the enrollment
Comorbidities
Tijdsspanne: At the enrollment
Standardized questionnaire
At the enrollment
Stage of the tumor
Tijdsspanne: At the enrollment
Standardized questionnaire
At the enrollment
Type of tumor
Tijdsspanne: At the enrollment
Standardized questionnaire
At the enrollment
Adherence to the exercise program
Tijdsspanne: After 4, 12, 24 and 48 weeks of intervention
Exercise adherence will be assessed through monitoring of training logs.
After 4, 12, 24 and 48 weeks of intervention
Total body mass
Tijdsspanne: From enrollment and at the end of the study, in 48 weeks
Will be measured using a digital scale
From enrollment and at the end of the study, in 48 weeks
Body height
Tijdsspanne: From enrollment and at the end of the study, at 48 weeks
Will be measured using a measuring tape with 1 mm resolution.
From enrollment and at the end of the study, at 48 weeks
Waist circunference
Tijdsspanne: From enrollment and at the end of the study, at 48 weeks
Will be measured using a measuring tape with 1 mm resolution.
From enrollment and at the end of the study, at 48 weeks
Nutritional assessment
Tijdsspanne: From enrollment and at the end of the study, at 48 weeks
Nutritional status will be evaluated using a three-day dietary recall.
From enrollment and at the end of the study, at 48 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Federal University of Rio Grande do Sul

Onderzoekers

  • Hoofdonderzoeker: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 maart 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 oktober 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • URioGrandeCancer

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Data will be provided only upon request, after the study is completed and published in a scientific journal.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren