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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
Sponsor:
Collaborator:
Universidade Estadual da Paraiba
Information provided by (Responsible Party):
Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Educational intervention Other: Aerobic exercise Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Simple blind (investigador/outcomes aseessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis: Randomized Controlled Trial
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: High Intensity Interval Training
The subjects will participate of an educational intervention and a High Intensity Interval Training.
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.

Active Comparator: Control Group
The subjects will participate of an educational 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Functional capacity [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
    The 3 minute step test

  4. Respiratory muscle strength [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
    Maximum respiratory pressure

  5. Exacerbations [ Time Frame: Measured at baseline, after 8 and 16 weeks. ]
    Exacerbations of Cystic Fibrosis through the criteria of Fuchs



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653949


Contacts
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Contact: Karolinne Monteiro, Master +5584996387722 karolsm@outlook.com.br
Contact: Thayla Santino, Master +5583999424386 thaylaamorim@gmail.com

Locations
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Brazil
Karolinne Souza Monteiro Recruiting
Natal, RN, Brazil, 59064-741
Contact: Karolinne S Monteiro, Master    5583996387722    karolsm@outlook.com.br   
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Universidade Estadual da Paraiba
Investigators
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Principal Investigator: Karolinne Monteiro, Master Universidade Federal do Rio Grande do Norte

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Responsible Party: Karla Morganna Pereira Pinto de Mendonça, Federal University of Rio Grande do Norte, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03653949     History of Changes
Other Study ID Numbers: 88024518.9.1001.5537
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte:
Cystic fibrosis
Insulin Resistance
Aerobic Exercise
Child
Adolescents
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases