Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT03653949 |
Recruitment Status :
Recruiting
First Posted : August 31, 2018
Last Update Posted : October 4, 2019
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Tracking Information | |||||||||
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First Submitted Date ICMJE | August 14, 2018 | ||||||||
First Posted Date ICMJE | August 31, 2018 | ||||||||
Last Update Posted Date | October 4, 2019 | ||||||||
Actual Study Start Date ICMJE | February 4, 2019 | ||||||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis | ||||||||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Masking Description: Simple blind (investigador/outcomes aseessor) Primary Purpose: Treatment
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Condition ICMJE | Cystic Fibrosis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2020 | ||||||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 18 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Brazil | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03653949 | ||||||||
Other Study ID Numbers ICMJE | 88024518.9.1001.5537 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte | ||||||||
Study Sponsor ICMJE | Universidade Federal do Rio Grande do Norte | ||||||||
Collaborators ICMJE | Universidade Estadual da Paraiba | ||||||||
Investigators ICMJE |
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PRS Account | Universidade Federal do Rio Grande do Norte | ||||||||
Verification Date | October 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |