Effects of Semisupervised Exercise Training on Health Outcomes in People With Lung or Head and Neck Cancer: Protocol for a Randomized Controlled Trial

Isis Grigoletto; Vinicius Cavalheri; Luis Alberto Gobbo; Karina Pozo; Enio Rodrigues Maia Filho; Diogo Gonçalves Ribeiro; Nara Ielo; Fabiano Francisco De Lima; Ercy Mara Cipulo Ramos

doi:10.2196/43547

Effects of Semisupervised Exercise Training on Health Outcomes in People With Lung or Head and Neck Cancer: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2023 May 24:12:e43547. doi: 10.2196/43547.

Authors

Isis Grigoletto^{1

2}, Vinicius Cavalheri^{3

4

5}, Luis Alberto Gobbo⁶, Karina Pozo^{1

2}, Enio Rodrigues Maia Filho², Diogo Gonçalves Ribeiro², Nara Ielo^{2

7}, Fabiano Francisco De Lima⁸, Ercy Mara Cipulo Ramos^{1

2}

Affiliations

¹ Department of Physiotherapy, Faculty of Science and Technology, São Paulo State University, Presidente Prudente, São Paulo, Brazil.
² Cancer Hospital of Presidente Prudente, Presidente Prudente, São Paulo, Brazil.
³ Curtin School of Allied Health, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
⁴ Curtin enAble Institute, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
⁵ Allied Health, South Metropolitan Health Service, Perth, Western Australia, Australia.
⁶ Department of Physical Education, Faculty of Science and Technology, São Paulo State University, Presidente Prudente, São Paulo, Brazil.
⁷ São Leopoldo Mandic Institute and Research Center, Campinas, São Paulo, Brazil.
⁸ Department of Physiotherapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.

PMID: 37223986
PMCID: PMC10248778
DOI: 10.2196/43547

Abstract

Background: Lung or head and neck cancers are known for their high prevalence and mortality rates. Chemotherapy and radiotherapy are usually recommended as cancer treatment for these malignancies; however, they can negatively impact both the physical and mental status of patients. Hence, it is reasonable to consider resistance and aerobic exercise training to prevent these negative health outcomes. Further, several factors prevent patients from attending outpatient exercise training programs, and, therefore, a semisupervised home-based exercise training program may be seen as a well-accepted alternative.

Objective: The aim of this study will be to investigate the effects of a semisupervised home-based exercise training program on physical performance, body composition, and self-reported outcomes; changes in the initial cancer treatment dose prescribed; number of hospitalizations at 3, 6, and 9 months; and 12-month survival in people with primary lung or head and neck cancer.

Methods: Participants will be randomly allocated to the training group (TG) or control group (CG). The TG will undergo semisupervised home-based resistance and aerobic exercise training throughout their cancer treatment. The resistance training will be performed using elastic bands (TheraBand) twice a week. The aerobic training (ie, brisk walk) will be performed for at least 20 minutes per day outdoors. The equipment and tools used during the training sessions will be provided. This intervention will start the week before treatment commencement, will be performed throughout the duration of the treatment, and will continue for 2 weeks after treatment completion. The CG will undergo usual care (ie, cancer treatment with no formal exercise prescription). Assessments will take place 2 weeks before the beginning of the usual cancer treatment and 2 weeks after treatment completion. The measures of physical function (peripheral muscle strength, functional exercise capacity, and physical activity), body composition, and self-reported outcomes (symptoms of anxiety and depression, health-related quality of life, and symptoms related to the disease and treatment) will be collected. We will report on any change in the initial cancer treatment dose prescribed; number of hospitalizations at 3, 6, and 9 months; and 12-month survival.

Results: In February 2021, the clinical trial registration was approved. Recruitment and data collection for the trial are ongoing (as of April 2023, 20 participants had already been randomized), and findings of this study are likely to be published late in 2024.

Conclusions: This exercise training as a complementary treatment for patients with cancer is likely to promote positive effects on the health outcomes assessed, over and above any change in the CG, and prevent the reduction of initial cancer treatment dose prescribed. If these positive effects are shown, they will likely impact long-term outcomes such as hospitalizations and 12-month survival.

Trial registration: Brazilian Clinical Trials Registry (ReBEC) RBR-5cyvzh9; https://ensaiosclinicos.gov.br/rg/RBR-5cyvzh9.

International registered report identifier (irrid): PRR1-10.2196/43547.

Keywords: ECOG; ENDT; Eastern Cooperative Oncology Group; HRQoL; QoL; RCT; aerobic exercise; cancer treatment; drug therapy; ear nose throat; ear, nose, and throat; exercise; head and neck neoplasms; head cancer; lung cancer; lung neoplasms; muscle strength; neck cancer; neoplasm; oncology; outpatient; physical activity; pulmonary; quality of life; radiotherapy.

©Isis Grigoletto, Vinicius Cavalheri, Luis Alberto Gobbo, Karina Pozo, Enio Rodrigues Maia Filho, Diogo Gonçalves Ribeiro, Nara Ielo, Fabiano Francisco De Lima, Ercy Mara Cipulo Ramos. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.05.2023.