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

27 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

180

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Brazylia
      • Porto Alegre, Brazylia, 91350-200
        • Rekrutacyjny
        • Hospital Conceição
        • Kontakt:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazylia, 90690-200
        • Jeszcze nie rekrutacja
        • Escola de Educação Física Fisioterapia e Dança - UFRGS
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Multicomponent Training
Multicomponent exercise
Behawioralne: 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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Gait ability
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
From enrollment and at 4, 12, 24 and 48 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Physical activity level
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Sociodemographic characteristics
Ramy czasowe: At the enrollment
Standardized questionnaire
At the enrollment
Comorbidities
Ramy czasowe: At the enrollment
Standardized questionnaire
At the enrollment
Stage of the tumor
Ramy czasowe: At the enrollment
Standardized questionnaire
At the enrollment
Type of tumor
Ramy czasowe: At the enrollment
Standardized questionnaire
At the enrollment
Adherence to the exercise program
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Federal University of Rio Grande do Sul

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 marca 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

27 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 kwietnia 2026

Ostatnia weryfikacja

1 października 2025

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • URioGrandeCancer

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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