Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 23, 2022
Date Accepted: Mar 21, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of a semi-supervised exercise training on health outcomes in people with lung or head and neck cancer: a randomized controlled trial protocol
ABSTRACT
Background:
Lung, head and neck cancers are known for their high prevalence and mortality rates. Chemotherapy and/or 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/or aerobic exercise training to prevent these negative health outcomes. Further, several factors prevent patients from attending outpatient exercise training programs and, therefore, a semi-supervised home-based exercise training program may be seen as a well-accepted alternative.
Objective:
The aims of this study will be to, in people with primary lung or head and neck cancer, investigate the effects of a semi-supervised home-based exercise training program on physical performance, body composition and self-reported outcomes, changes on the initial cancer treatment dose prescribed, number of hospitalizations in three, six and nine months as well as on 12-month survival.
Methods:
Participants will be randomly allocated into the TG: Training Group, or the CG: Control Group. The TG will undergo a semi-supervised home-based resistance and aerobic exercise training program throughout the duration of their cancer treatment. This intervention will start the week before treatment commencement, will be performed throughout the duration of the treatment and will continue for two weeks after treatment completion. The CG will undergo usual care (i.e. cancer treatment with no formal exercise prescription). Assessments will take place two weeks before the beginning of the usual cancer treatment and two weeks after treatment completion. Measures will be collected of physical function (peripheral muscle strength, functional exercise capacity and physical activity), body composition, self-reported outcomes (symptoms of anxiety and depression, health-related quality of life and symptoms related to the disease and treatment). We will report on any change on the initial cancer treatment dose prescribed, number of hospitalizations in three, six and nine months, as well as on 12-month-survival.
Results:
In February 2021, the clinical trial submission was approved, the recruitment did not start yet and the results of this study must be published in 2024.
Conclusions:
This exercise training as a complementary treatment to cancer patients may promote positive effects on the health outcomes assessed and prevent reduction of initial cancer treatment dose prescribed. These positive effects are likely to result in improved long-term outcomes in this population. Clinical Trial: Trial registration: Brazilian Clinical Trials Registry (ReBEC) ID: RBR-5cyvzh9. Registred: February 12, 2021. https://ensaiosclinicos.gov.br/rg/RBR-5cyvzh9
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