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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 23, 2024
Date Accepted: Jul 9, 2024

The final, peer-reviewed published version of this preprint can be found here:

Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment

Selles WdL, Miyamoto GC, Santos EdC, Carmo CRL, Moura GM, Santos GMF, Lopes GdS, Silva DW, Pereira LJF, Lunardi AC

Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment

JMIR Res Protoc 2024;13:e60828

DOI: 10.2196/60828

PMID: 39163116

PMCID: 11372328

Effectiveness of aerobic training on adverse symptoms related to chemotherapy during treatment: protocol of a randomized controlled trial with cost-effectiveness assessment.

  • William de Lima Selles; 
  • Gisela Cristiane Miyamoto; 
  • Elinaldo da Conceição Santos; 
  • Cibelle Regina Lima Carmo; 
  • Giovanni Marini Moura; 
  • Giovanna Marques Frascoli Santos; 
  • Giovanna dos Santos Lopes; 
  • Diego Wisnieski Silva; 
  • Leticia Jeremias Ferreira Pereira; 
  • Adriana Claudia Lunardi

ABSTRACT

Background:

One of the strategies to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in breast cancer patients, usually a few weeks after starting chemotherapy, on an outpatient basis, two to three times a week. The main differences of our study are: carrying out physical training in hospitalized patients to undergo a cycle of chemotherapy for cancer treatment, this training being carried out five times a week and not being restricted to a specific type of cancer.

Objective:

To evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia and sensation of weakness), fatigue, mobility, clinical complications and length of hospital stay of patients during the drug treatment cycle. The adverse effects of training aerobics and patient satisfaction with the proposed intervention. In addition to also evaluating the cost-effectiveness of this intervention.

Methods:

This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized cancer patients for one or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using the Linear Mixed Model, regarding fatigue, mobility and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the chi-square test. Cost-effectiveness and cost-utility analyzes will be performed for the impact of exercise and quality-adjusted life years (QALYs) through the EQ-5D3L21 quality of life trials. The implementation variables (acceptability, suitability and feasibility) will be evaluated by frequencies.

Results:

In March 2023, the clinical trial registration was approved. Recruitment and data collection for the trial is ongoing, and the results of this study are likely to be published in late 2025.

Conclusions:

Impact: Chemotherapy has side effects that negatively impact the quality of life of cancer patients. Aerobic exercise can reduce those side effects in a simple and inexpensive way. Oncology could be an expanded field of work for physical therapists if the intervention works Clinical Trial: RBR-6b4zwx3. Acess: https://ensaiosclinicos.gov.br/rg/RBR-6b4zwx3


 Citation

Please cite as:

Selles WdL, Miyamoto GC, Santos EdC, Carmo CRL, Moura GM, Santos GMF, Lopes GdS, Silva DW, Pereira LJF, Lunardi AC

Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment

JMIR Res Protoc 2024;13:e60828

DOI: 10.2196/60828

PMID: 39163116

PMCID: 11372328

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