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临床试验/NCT03653949
NCT03653949Unknown不适用

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

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Change in glucose tolerance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Simple blind (investigador/outcomes aseessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in glucose tolerance

时间窗: Measured at baseline, after 8 and 16 weeks.

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

次要结局

  • Respiratory muscle strength(Measured at baseline, after 8 and 16 weeks.)
  • Exacerbations(Measured at baseline, after 8 and 16 weeks.)
  • Functional capacity(Measured at baseline, after 8 and 16 weeks.)
  • Cystic fibrosis Quality of life(Measured at baseline, after 8 and 16 weeks.)
  • Lung Function(Measured at baseline, after 8 and 16 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karla Morganna Pereira Pinto de Mendonça

Federal University of Rio Grande do Norte

Universidade Federal do Rio Grande do Norte

研究点 (2)

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