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Influence of High-intensity Interval Training in Obese Adolescents With and Without Insulin Resistance ()

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ClinicalTrials.gov Identifier: NCT03042234
Recruitment Status : Not yet recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
JULIANA MONIQUE LINO, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:

According to the literature, high-intensity interval training (HIIT) emerges as a potential training strategy capable of promoting positive adaptations to the health of obese children and adolescents, as it demands less execution time (less volume) and can be considered motivationally, More attractive to this audience. However, few studies have adopted the "anaerobic threshold" concept and high intensity interval cardiorespiratory training to evaluate the oxidation of energetic substrates during and after physical activity in obese adolescents with and without insulin resistance.

In this context, this study aims to analyze the effects of high intensity interval training on lipid and glycemic profile, cardiorespiratory parameters, metabolism of substrates, and functional capacity of obese adolescents with and without insulin resistance.


Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Adolescent Other: Group I Other: Group II Other: Group III Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of High-intensity Interval Training on the Anaerobic Threshold and Substrates Oxidation in Obese Adolescents With and Without Insulin Resistance
Estimated Study Start Date : February 2, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I
Adolescents obese with insulin resistance
Other: Group I
High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Other Name: Adolescents obese with insulin resistance

Experimental: Group II
Adolescents obese without insulin resistance
Other: Group II
High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Other Name: Adolescent obese without insulin resistance

Experimental: Group III
Adolescents eutrophyc
Other: Group III
High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Other Name: Adolescent eutrophyc




Primary Outcome Measures :
  1. Respiratory exchange ratio measured by ergospirometry at rest [ Time Frame: Baseline and 4 weeks (end of intervention) ]
    Assessed using a maximal treadmill test.

  2. Peak VO2 measured by ergospirometry during maximal exercise testing [ Time Frame: Baseline and 4 weeks (end of intervention) ]
    Assessed using a maximal treadmill test.

  3. Ventilatory threshold measured by ergospirometry during maximal exercise testing [ Time Frame: Baseline and 4 weeks (end of intervention) ]
    Assessed using a maximal treadmill test.

  4. FATmax (% of maximal oxygen consumption) [ Time Frame: Baseline and 4 weeks (end of intervention) ]
    Assessed during the incremental stage maximal cardio-respiratory fitness test

  5. Whole-body substrate oxidation rates [ Time Frame: Baseline and 4 weeks (end of intervention) ]
    Assessed during the incremental stage maximal cardio-respiratory fitness test


Secondary Outcome Measures :
  1. Body Weight [ Time Frame: Baseline and 4 weeks ]
  2. Blood Pressure [ Time Frame: Baseline and 4 weeks ]
  3. Body Mass Index [ Time Frame: Baseline and 4 weeks ]
  4. Body composition [ Time Frame: Baseline and 4 weeks ]
    Assessed using Bioelectric impedance (using Biodynamics 450)

  5. Blood biochemistry [ Time Frame: Baseline and 4 weeks ]
    Analysed for lipids

  6. Blood biochemistry [ Time Frame: Baseline and 4 weeks ]
    Analysed for glucose

  7. Blood biochemistry [ Time Frame: Baseline and 4 weeks ]
    Analysed for insulin

  8. Blood biochemistry [ Time Frame: Baseline and 4 weeks ]
    Analysed for HOMA-index by measuring the blood glucose and fasting insulin.

  9. Physical activity [ Time Frame: Baseline and 4 weeks ]
    Assessed through IPAQ

  10. Quality of life [ Time Frame: Baseline and 4 weeks ]
    Assessed through the Paediatric Quality of Life Inventory

  11. Maximum respiratory pressure measurements by means of a manometer: maximum inspiratory pressure (Pimax) [ Time Frame: Baseline and 4 weeks ]
    Assessed using a manovacuometer

  12. Maximum respiratory pressure measurements by means of a manometer: maximum expiratory pressure (Pemax) [ Time Frame: Baseline and 4 weeks ]
    Assessed using a manovacuometer

  13. Spirometric analysis [ Time Frame: change from baseline at 4 weeks ]
    Analysed for forced vital capacity. Assessed using a Software Koko Spirometer, Spirometer Koko (PDS Instrumentation®).

  14. Spirometric analysis [ Time Frame: change from baseline at 4 weeks ]
    Analysed for forced expiratory volume in the first second. Assessed using a Software Koko Spirometer, Spirometer Koko (PDS Instrumentation®).

  15. Spirometric analysis [ Time Frame: change from baseline at 4 weeks ]
    Analysed for forced expiratory flow 25-75 %. Assessed using a Software Koko Spirometer, Spirometer Koko (PDS Instrumentation®).

  16. Spirometric analysis [ Time Frame: change from baseline at 4 weeks ]
    Analysed for ratio of forced expiratory volume in the first second. Assessed using a Software Koko Spirometer, Spirometer Koko (PDS Instrumentation®).

  17. Six-minute walk test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of distance in six-minute walk test.

  18. Six-minute walk test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of oxygen saturation at end of test.

  19. Six-minute walk test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of blood pressure at end of test.

  20. Six-minute walk test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of heart rate at end of test.

  21. Six-minute step test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of distance in six-minute step test.

  22. Six-minute step test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of oxygen saturation at end of test.

  23. Six-minute step test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of blood pressure at end of test.

  24. Six-minute step test [ Time Frame: change from baseline at 4 weeks ]
    Analysis of heart rate at end of test.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 8 and 12 years;
  • Pubertal stage >3, acooording to the Tanner system of pubertal staging;
  • Sedentary or irregurarly active, according to theIPAQ;
  • Body mass index (BMI), according to the World Health Organization;
  • No pharmacological treatment;
  • No evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement;
  • No participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.

Exclusion Criteria:

• Participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program


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): NCT03042234


Contacts
Contact: Juliana Monique Lino Aparecido +55-11-969975162 juliana.monique@unicid.edu.br
Contact: Vera Lúcia dos Santos Alves, PhD +55-11-999707013 fisioterapiasc@uol.com.br

Locations
Brazil
Santa Casa of Sao Paulo School
Sao Paulo, Brazil, 01221-020
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: Juliana Monique Lino Aparecido Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications:
ROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009
KLOSTER, R & LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306
FOUREAUX, G; PINTO, KMC; DÂMASO, A. Efeito do consumo excessivo de oxigênio após exercício e da taxa metabólica de repouso no gasto energético. Rev Bras Med Esporte. 2006 nov-dez; 12(6):393-398.
AMERICAN COLLEGE OF SPORTS MEDICINE - ACSM. ACSM's Guidelines for Exercise Testing and Prescription. 8ª edição. Baltimore: Williams & Wilkins, 2009.
MARQUEZI, ML. Adaptações decorrentes do exercício cardiorrespiratório sobre a oxidação de lipídeos: exercício aeróbio. Rev Mackenzie de Educação Física e Esporte. 2010; 9(1):32-35.
MARQUEZI, ML; DUARTE, L; SCHWARTZ, J; SOUSA, PCR. Variabilidade interindividual da oxidação de substratos durante o exercício. Rev Mackenzie de Educação Física e Esporte. 2009; 8(1): 3-19.
TANNER JM. Growth at adolescence. Oxford: Blackwell Scientific Pub; 1962.
MATSUDO, SM; ARAÚJO, TL; MATSUDO, VKR; ANDRADE, DR; ANDRADE, EL; OLIVEIRA, LC; et al. Questionário Internacional de Atividade Física (IPAQ): estudo de validade e reprodutibilidade no Brasil. Rev Bras Ativ Saude. 2001;10:5-18.

Responsible Party: JULIANA MONIQUE LINO, Principal investigator Juliana Monique Lino Aparecido, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03042234     History of Changes
Other Study ID Numbers: japarecido
34634414.5.0000.5479 ( Registry Identifier: CAAE )
1.227.250 ( Other Identifier: Number of opinion )
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by JULIANA MONIQUE LINO, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Obesity
Exercise
Fat oxidation
Adolescent
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs