Effects of aerobic interval training on glucose tolerance in children and adolescents with cystic fibrosis: a randomized trial protocol

Karolinne Souza Monteiro, Matheus de Paiva Azevedo, Lucas Menescal Jales, Fernanda Elizabeth Pereira da Silva, Ricardo Fernando Arrais, Karla Morganna Pereira Pinto de Mendonça, Karolinne Souza Monteiro, Matheus de Paiva Azevedo, Lucas Menescal Jales, Fernanda Elizabeth Pereira da Silva, Ricardo Fernando Arrais, Karla Morganna Pereira Pinto de Mendonça

Abstract

Background: Individuals with cystic fibrosis (CF) may develop CF-related diabetes (CFDR). This comorbidity is related to a poorer quality of life, microvascular complications, a decline in lung function, and an increase in exacerbations, as well as delayed growth and puberty. Evidence exists that physical exercise contributes to glycemic control in individuals with non-CF-related diabetes. This exercise is usually continuous with moderate intensity and long duration, which can cause muscle dyspnea and fatigue in CF individuals. Aerobic interval training (AIT) emerges as a safe and effective alternative for treating these individuals. The objective of this study is to evaluate the effects of AIT on glucose tolerance in children and adolescents with CF.

Methods: This study will be a two-arm, prospectively registered, randomized controlled trial with blind assessors and twenty 6- to 18-year-old individuals with cystic fibrosis (CF) from two different Brazilian states. People with CF will be randomly allocated to either the experimental or control group using block randomization, stratified by puberty stage,. Participants from both groups will receive an educational intervention and will be asked to continue their usual daily treatment for the full duration of the study. Those in the experimental group will perform AIT on a cycle ergometer at home three times a week, for 8 consecutive weeks. The sample characterization will include an assessment of puberty stage, socioeconomic status, dyspnea, and anthropometry. The primary outcome will be the change in glucose tolerance, while the secondary outcomes will include lung function, exercise tolerance, respiratory muscle strength, quality of life, and CF exacerbations. All outcomes will be assessed at baseline, week 9, and week 17.

Discussion: This is the first study to evaluate the effects of AIT on glucose tolerance in children and adolescents with CF. This study will serve as a basis for guiding clinical practice and decision-making in treating glucose intolerance and CF-related diabetes (CFRD) in children and adolescents with CF.

Trial registration: ClinicalTrials.gov Protocol Registration System: NCT03653949. Registered on August 31, 2018.

Keywords: Cystic fibrosis, Glucose tolerance, Aerobic exercise, Exercise, Respiratory function tests.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of the planned protocol
Fig. 2
Fig. 2
Study design schedule in accordance with the standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist

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