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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Gait ability — 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)
• Hand grip strength — 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).
• SPPB Battery — 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)
• Peak power on seat to standing movement — 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.
• number of hospitalizations — From enrollment and at the end of the study, in 48 weeks
  Standardized questionnaire
• Treatment toxicity — 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).
• Mortality rate — From enrollment and at the end of the study, in 48 weeks
  Standardized questionnaire
• Number of falls — From enrollment and at 4, 12, 24 and 48 weeks
  Standardized questionnaire

Trial sites (2)

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