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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03653949
• Other study ID #: 88024518.9.1001.5537
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Karolinne Monteiro, Master
• Phone: +5584996387722
• Email: karolsm[@]outlook.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Educational 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.
• Aerobic 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.

Locations

Country	Name	City	State
Brazil	Karolinne Souza Monteiro	Natal	RN

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte	Universidade Estadual da Paraiba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose tolerance	Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.	Measured at baseline, after 8 and 16 weeks.
Secondary	Cystic fibrosis Quality of life	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.	Measured at baseline, after 8 and 16 weeks.
Secondary	Lung Function	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).	Measured at baseline, after 8 and 16 weeks.
Secondary	Functional capacity	The 3 minute step test	Measured at baseline, after 8 and 16 weeks.
Secondary	Respiratory muscle strength	Maximum respiratory pressure	Measured at baseline, after 8 and 16 weeks.
Secondary	Exacerbations	Exacerbations of Cystic Fibrosis through the criteria of Fuchs	Measured at baseline, after 8 and 16 weeks.