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Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis

Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653949
Enrollment
20
Registered
2018-08-31
Start date
2019-02-04
Completion date
2020-12-31
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis, Insulin Resistance, Aerobic Exercise, Child, Adolescents

Brief summary

The purpose of this study is to investigate the effects of aerobic exercise on glucose tolerance in individuals with cystic fibrosis. The hypothesis is that performing High Intensity Interval Training glucose tolerance will improve in individuals with cystic fibrosis.

Detailed description

This is a controlled, randomized, and single blind trial. The first researcher (P1) will be responsible for the randomization process; the second researcher (P2) will be responsible for the evaluations and reevaluations. This evaluator (P2) will be blind, meaning that for him it is totally unknown in which group each patient will be insert; and the third researcher (P3), will be responsible for statistical analysis. Individuals will be recruited at the Child and Adolescent Health Care Unit of the Onofre Lopes University Hospital (HUOL) and in the Department of Physical Therapy of the State University of Paraíba (UEPB), Campina Grande - PB, Brazil. They will be evaluated at the Physical Therapy Department of the Federal University of Rio Grande do Norte (UFRN), Natal - RN, Brazil and in the Department of Physical Therapy of the State University of Paraíba (UEPB), in the city of Campina Grande - PB. A pilot study will be carried out and the sample calculation will be done with the data collected to reach a statistical power of 80% and a level of significance of 0.05%. Allocation in the groups will be performed by P1, randomly in blocks by the volunteer being prepubertal or pubertal. The R Core Team software (2015) will be used for this process. In this study two groups will be considered: control group (CG) and aerobic exercise group (AEG). The CG will be submitted to educational intervention. The AEG will be submitted to the same educational intervention and to the High Intensity Interval Training. After the pilot study, the patients will be evaluated to obtain information on severity and exacerbation of the disease, quality of life, metabolic evaluation, anthropometric measures, and lung function. All evaluations will be carried out at the same day period (morning). Researcher two (P2) will be responsible for the evaluation and reassessment procedure of the individuals, hence he will be blind meaning that for him it is totally unknown in which group each patient will be or was inserted. Individuals will be instructed to do not perform physical activity in the day before the evaluations. After this step, individuals will be randomly distributed in CG or EAG. Volunteers from both groups will be instructed to maintain nutritional, drug and secretion care. In addition, they will be instructed to do not get engaged in any other kind of physical activity. The intervention will last 2 months and will occur 3 times a week until a total of 24 sessions. After the intervention ends and after the 8-week follow-up, all volunteers will be reevaluated.

Interventions

OTHEREducational intervention

It will be an interactive lecture, 60 minutes long. The class will cover physiopathology, complications, treatment and prevention of exacerbations. Audiovisual resources and practical demonstrations of usual care will be used. Individual questions will be answered during the class.

OTHERAerobic exercise

The aerobic exercise program will be performed at home, on a cycle ergometer for lower limbs between 24 and 35 minutes: 5 minutes of warm-up, 14 to 25 minutes of high-intensity interval exercise and 5 minutes of cool down.

Sponsors

Universidade Estadual da Paraiba
CollaboratorOTHER
Universidade Federal do Rio Grande do Norte
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Simple blind (investigador/outcomes aseessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of cystic fibrosis, according to the Brazilian Guidelines for diagnosis and treatment of CF; * Prepubertal or pubertal, according to the Tanner scale * Both sex.

Exclusion criteria

* Inability to perform the protocol established to the study; * To be unable to understand and / or perform procedures. * Exacerbation of the clinical picture, defined as modification and / or addition of antibiotic. * To be pregnant.

Design outcomes

Primary

MeasureTime frameDescription
Change in glucose toleranceMeasured at baseline, after 8 and 16 weeks.Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.

Secondary

MeasureTime frameDescription
Cystic fibrosis Quality of lifeMeasured at baseline, after 8 and 16 weeks.the Quality of Life Questionnaire in Cystic Fibrosis (QFC) was translated and validated into Portuguese in 2006. There are four versions of the questionnaire, according to age group: 6 to 11 years (35 questions), 12 and 13 years (35 questions), 14 years or more (50 questions) and parents of children between 6 and 11 years old (44 questions). For children between 6 and 11 years old the application of the questionnaire will be assisted by special cards that will designate the child's response. The questionnaire addresses the physical, body image, digestive, respiratory, emotional, social, nutrition, treatment, vitality, health, social role and weight domains. The scores of each domain range from zero to 100, considering a good quality of life if score above 50.
Lung FunctionMeasured at baseline, after 8 and 16 weeks.Forced expired volume in one second (FEV1) and forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75).
Functional capacityMeasured at baseline, after 8 and 16 weeks.The 3 minute step test
Respiratory muscle strengthMeasured at baseline, after 8 and 16 weeks.Maximum respiratory pressure
ExacerbationsMeasured at baseline, after 8 and 16 weeks.Exacerbations of Cystic Fibrosis through the criteria of Fuchs

Countries

Brazil

Contacts

Primary ContactKarolinne Monteiro, Master
karolsm@outlook.com.br+5584996387722
Backup ContactThayla Santino, Master
thaylaamorim@gmail.com+5583999424386

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026