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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
      • Porto Alegre, Brasilien, 91350-200
        • Rekruttering
        • Hospital Conceição
        • Kontakt:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90690-200
        • Ikke rekrutterer endnu
        • Escola de Educação Física Fisioterapia e Dança - UFRGS
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multicomponent Training
Multicomponent exercise
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gait ability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
From enrollment and at 4, 12, 24 and 48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sociodemographic characteristics
Tidsramme: At the enrollment
Standardized questionnaire
At the enrollment
Comorbidities
Tidsramme: At the enrollment
Standardized questionnaire
At the enrollment
Stage of the tumor
Tidsramme: At the enrollment
Standardized questionnaire
At the enrollment
Type of tumor
Tidsramme: At the enrollment
Standardized questionnaire
At the enrollment
Adherence to the exercise program
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of Rio Grande do Sul

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. marts 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • URioGrandeCancer

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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