Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
27. dubna 2026 aktualizováno: 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.
Přehled studie
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
180
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Eduardo L Cadore, PhD
- Telefonní číslo: +555191193651
- E-mail: edcadore@yahoo.com.br
Studijní místa
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Porto Alegre, Brazílie, 91350-200
- Nábor
- Hospital Conceição
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Kontakt:
- Eduarda Blanco Rambo, Me
- Telefonní číslo: 5551999079773
- E-mail: eduardarambo@gmail.com
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90690-200
- Zatím nenabíráme
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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Kontakt:
- Eduardo L Cadore, PhD
- Telefonní číslo: +555191193651
- E-mail: edcadore@yahoo.com.br
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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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Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Gait ability
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Physical activity level
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sociodemographic characteristics
Časové okno: At the enrollment
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Standardized questionnaire
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At the enrollment
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Comorbidities
Časové okno: At the enrollment
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Standardized questionnaire
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At the enrollment
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Stage of the tumor
Časové okno: At the enrollment
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Standardized questionnaire
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At the enrollment
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Type of tumor
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
2. března 2026
Primární dokončení (Odhadovaný)
1. března 2027
Dokončení studie (Odhadovaný)
1. června 2027
Termíny zápisu do studia
První předloženo
27. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
27. dubna 2026
První zveřejněno (Aktuální)
4. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. dubna 2026
Naposledy ověřeno
1. října 2025
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- URioGrandeCancer
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Data will be provided only upon request, after the study is completed and published in a scientific journal.
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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