Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
27 april 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
180
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Eduardo L Cadore, PhD
- Telefonnummer: +555191193651
- E-post: edcadore@yahoo.com.br
Studieorter
-
-
-
Porto Alegre, Brasilien, 91350-200
- Rekrytering
- Hospital Conceição
-
Kontakt:
- Eduarda Blanco Rambo, Me
- Telefonnummer: 5551999079773
- E-post: eduardarambo@gmail.com
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90690-200
- Har inte rekryterat ännu
- Escola de Educação Física Fisioterapia e Dança - UFRGS
-
Kontakt:
- Eduardo L Cadore, PhD
- Telefonnummer: +555191193651
- E-post: edcadore@yahoo.com.br
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Multicomponent Training
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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gait ability
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From enrollment and at 4, 12, 24 and 48 weeks
|
Standardized questionnaire
|
From enrollment and at 4, 12, 24 and 48 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physical activity level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sociodemographic characteristics
Tidsram: At the enrollment
|
Standardized questionnaire
|
At the enrollment
|
|
Comorbidities
Tidsram: At the enrollment
|
Standardized questionnaire
|
At the enrollment
|
|
Stage of the tumor
Tidsram: At the enrollment
|
Standardized questionnaire
|
At the enrollment
|
|
Type of tumor
Tidsram: At the enrollment
|
Standardized questionnaire
|
At the enrollment
|
|
Adherence to the exercise program
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 mars 2026
Primärt slutförande (Beräknad)
1 mars 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
27 april 2026
Först inskickad som uppfyllde QC-kriterierna
27 april 2026
Första postat (Faktisk)
4 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 april 2026
Senast verifierad
1 oktober 2025
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- URioGrandeCancer
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Data will be provided only upon request, after the study is completed and published in a scientific journal.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .