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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Aging
• Intervention / Treatment: Behavioral: Multicomponent exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo L Cadore, PhD; Phone Number: +555191193651; Email: edcadore@yahoo.com.br

Study Locations

• Brazil
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Hospital Conceição
    • Contact: Eduarda Blanco Rambo, Me; Phone Number: 5551999079773; Email: eduardarambo@gmail.com
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
      • Not yet recruiting
      • Escola de Educação Física Fisioterapia e Dança - UFRGS
      • Contact: Eduardo L Cadore, PhD; Phone Number: +555191193651; Email: edcadore@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent Training; Multicomponent exercise	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait ability	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	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	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	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	Standardized questionnaire	From enrollment and at the end of the study, in 48 weeks
Treatment toxicity	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	Standardized questionnaire	From enrollment and at the end of the study, in 48 weeks
Number of falls	Standardized questionnaire	From enrollment and at 4, 12, 24 and 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	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	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	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	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	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	Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)	From enrollment and at 4, 12, 24 and 48 weeks
Sleep quality	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	Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)	From enrollment and at 4, 12, 24 and 48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic characteristics	Standardized questionnaire	At the enrollment
Comorbidities	Standardized questionnaire	At the enrollment
Stage of the tumor	Standardized questionnaire	At the enrollment
Type of tumor	Standardized questionnaire	At the enrollment
Adherence to the exercise program	Exercise adherence will be assessed through monitoring of training logs.	After 4, 12, 24 and 48 weeks of intervention
Total body mass	Will be measured using a digital scale	From enrollment and at the end of the study, in 48 weeks
Body height	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	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	Nutritional status will be evaluated using a three-day dietary recall.	From enrollment and at the end of the study, at 48 weeks

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Eduardo L Cadore, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Aging; Neoplasia
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity
• Other Study ID Numbers: URioGrandeCancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be provided only upon request, after the study is completed and published in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No