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

NCT07565519 | Recruiting

• 1 other identifier: URioGrandeCancer
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer; Aging

Keywords

Aging; Neoplasia; Physical activity

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Physical activity level

  From enrollment and at the end of the study, in 48 weeks

• Vastus lateralis muscle thickness

  From enrollment and at 4, 12, 24 and 48 weeks

• Vastus intermedius muscle thickness

  From enrollment and at 4, 12, 24 and 48 weeks

• Rectus femoralis muscle thickness

  From enrollment and at 4, 12, 24 and 48 weeks

• Quality of Life Questionnarie

  From enrollment and at 4, 12, 24 and 48 weeks

Other Outcomes (9)

• Sociodemographic characteristics

  At the enrollment

• Comorbidities

  At the enrollment

• Stage of the tumor

  At the enrollment

Study Arms (2)

Multicomponent Training

EXPERIMENTAL

Multicomponent exercise

Behavioral: Multicomponent exercise

Control

NO INTERVENTION

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.

Interventions

Multicomponent exercise BEHAVIORAL

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.

Multicomponent Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (2)

Escola de Educação Física Fisioterapia e Dança - UFRGS

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

NOT YET RECRUITING

Hospital Conceição

Porto Alegre, 91350-200, Brazil

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eduardo L Cadore, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo L Cadore, PhD

CONTACT

+555191193651; edcadore@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person responsible for the randomization will not be one of the researchers involved in the assessments and will have no contact with the participants. Questionnaires and tests will be administered by evaluators blinded to the participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)