Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multicomponent exercise.
- Who it may be relevant to
- Registry conditions: Cancer, Aging. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Interventions
- 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 h
Primary outcome measures
- Gait ability [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Hand grip strength [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- SPPB Battery [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Peak power on seat to standing movement [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- number of hospitalizations [Time frame: From enrollment and at the end of the study, in 48 weeks]
- Treatment toxicity [Time frame: From enrollment and at the end of the study, in 48 weeks]
- Mortality rate [Time frame: From enrollment and at the end of the study, in 48 weeks]
- Number of falls [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
Secondary outcome measures (8)
- Physical activity level [Time frame: From enrollment and at the end of the study, in 48 weeks]
- Vastus lateralis muscle thickness [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Vastus intermedius muscle thickness [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Rectus femoralis muscle thickness [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Quality of Life Questionnarie [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Fatigue related symptons [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Sleep quality [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
- Disease prognosis [Time frame: From enrollment and at 4, 12, 24 and 48 weeks]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 2 centers
- Escola de Educação Física Fisioterapia e Dança - UFRGS — Porto Alegre
- Hospital Conceição — Porto Alegre
Identifiers
NCT: NCT07565519 · URioGrandeCancer