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

• ClinicalTrials.gov Identifier: NCT03653949
• Recruitment Status: Recruiting
• First Posted: August 31, 2018
• Last Update Posted: October 4, 2019
• Sponsor: Universidade Federal do Rio Grande do Norte
• Collaborator: Universidade Estadual da Paraiba
• Information provided by (Responsible Party): Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte

Tracking Information

• First Submitted Date: August 14, 2018
• First Posted Date: August 31, 2018
• Last Update Posted Date: October 4, 2019
• Actual Study Start Date: February 4, 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 2, 2019)

Change in glucose tolerance [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]

Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.

Original Primary Outcome Measures (submitted: August 28, 2018)

Change in insulin resistance [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]

Insulin resistance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.

Current Secondary Outcome Measures (submitted: March 12, 2019)

• Cystic fibrosis Quality of life [ Time Frame: Measured 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 Function [ Time Frame: Measured 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 capacity [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
  The 3 minute step test
• Respiratory muscle strength [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
  Maximum respiratory pressure
• Exacerbations [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
  Exacerbations of Cystic Fibrosis through the criteria of Fuchs

Original Secondary Outcome Measures (submitted: August 28, 2018)

• Cystic fibrosis Quality of life [ Time Frame: Measured 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 Function [ Time Frame: Measured 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 capacity [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
  The 3 minute step test
• Respiratory muscle strength [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
  Maximum respiratory pressure

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Simple blind (investigador/outcomes aseessor)

Primary Purpose: Treatment

• Condition: Cystic 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.
• Other: 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.

Study Arms

• Experimental: High Intensity Interval Training
  The subjects will participate of an educational intervention and a High Intensity Interval Training.
  Interventions:

  • Other: Educational intervention
  • Other: Aerobic exercise
• Active Comparator: Control Group
  The subjects will participate of an educational intervention.
  Intervention: Other: Educational intervention

• Publications *: Monteiro KS, Azevedo MP, Jales LM, da Silva FEP, Arrais RF, de Mendonça KMPP. Effects of aerobic interval training on glucose tolerance in children and adolescents with cystic fibrosis: a randomized trial protocol. Trials. 2019 Dec 26;20(1):768. doi: 10.1186/s13063-019-3803-8.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 28, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Karolinne Monteiro, Master; +5584996387722; karolsm@outlook.com.br

Contact: Thayla Santino, Master; +5583999424386; thaylaamorim@gmail.com

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03653949
• Other Study ID Numbers: 88024518.9.1001.5537
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte
• Study Sponsor: Universidade Federal do Rio Grande do Norte
• Collaborators: Universidade Estadual da Paraiba

Investigators

• Principal Investigator: Karolinne Monteiro, Master; Universidade Federal do Rio Grande do Norte

• PRS Account: Universidade Federal do Rio Grande do Norte
• Verification Date: October 2019