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Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Jump exercise
Aquatic exercise
Nutritional guidance
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Cardiometabolic risk factors, Adolescents, Exercise

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pubescent and post-pubescent adolescents are included, of both gender, who have overweight or obese, and waist / height ratio greater than 0.50
  • Without disabling the practice of physical exercise conditions and not using medications that may affect the outcome of the present study, such as medications to control cholesterol for hormone treatments and diuretics

Exclusion Criteria:

  • Those adolescents who become pregnant during the training will be deleted

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Jump exercise

    Aquatic exercise

    Nutritional guidance

    Arm Description

    rebound exercises.

    Hydrogimnastic.

    Nutritional counseling classes.

    Outcomes

    Primary Outcome Measures

    Body Mass Index

    Secondary Outcome Measures

    Waist circumference
    Blood Pressure
    HDL-cholesterol
    Triglycerides
    Fasting glycemia
    Body Fat Percentage
    Bioeletrical Impedance

    Full Information

    First Posted
    December 3, 2014
    Last Updated
    December 4, 2014
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02309034
    Brief Title
    Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity
    Official Title
    Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity: a Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Federal University of Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: To compare the results of two types of low-impact exercise training, in and out of the water, with the control group, regarding cardiometabolic risk factors in overweight adolescents; and to investigate the changes resulting from interventions in biochemical, anthropometric, psychological variables and body composition. Experimental design: Randomized clinical trial with overweight and obesity adolescents. Local Search: College of Physical Education of Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil. Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre city. Intervention: Adolescents that acepted to participate in the study, and authorized by their parents, were randomized into three groups: Group Land / Jump, with three weekly sessions Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control group that not participate in physical exercise intervention. The intervention will last 12 weeks and three groups participate in weekly sessions of nutritional guidance. Assessments occur at the beginning of the intervention program and 72 hours after the 12th week of the program. The results of all study variables among the three groups in the two time points, and in each group between the two periods, will compared. Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to applying instruments for assessing quality of life, body image and mental health by experienced evaluators, as well as blood draws conducted by an experienced gatherer's Hospital de Clínicas de Porto Alegre. Expected Results: In the study, are been expected to verify that the exercise programs, aquatic and land, associated with nutritional guidance, are efficient to modify positively the outcomes studied.
    Detailed Description
    Methods: The sample will be selected intentionally with 75 subjects. Those who agree to participate in the study will be randomly allocated into three groups by a blinded evaluator for the study, which will use online www.randomizer.org the software as follows: aqua + nutritional counseling, jump + nutritional counseling, group control (nutritional counseling only), all with 12-week duration. The study examine the effects obtained by the three groups on outcomes of cardiometabolic risk factors (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose), outcomes of amount and distribution of body fat (sum of skinfolds - triceps subscapular, suprailiac, abdominal and mid thigh - by bioelectrical impedance body fat percentage and waist / height), and psychological variables (quality of life, body image and mental health). In addition, nutritional counseling at weekly sessions will be used as a control variable. Characterization data of the sample (age, sex, weight, height, and waist / height) and other biochemical endpoints also comprise the study (total cholesterol, LDL-cholesterol, fasting insulin, HOMA-IR, QUICK, and high-sensitivity C- reactive protein will be collected). All measurements follow standard and validated procedures for the population object of study. To the chronic effect analysis, blood samples will be collected two times, before and after training period, with 12 hours fasting. To avoid the acute effect of the exercises, the measurements will done 72 hours after the 12th week. A sample of 5 ml of blood per antecubital vein will collected. The sample will be collected at the school for experienced gatherer, and will be taken immediately to the laboratory in order to ensure that analyzes are performed on the same day. The health-related quality of life will assessed using the questionnaire on pediatric quality of life PedsQL 4.0, adolescents and their parents. For analysis of body satisfaction instrument Body Shape Questionnaire BSQ will used. To ascertain the perception of body image will applied to Scale Silhouettes of Stunkard. Mental health will assessed using the Strengths and Difficulties Questionnaires SDQ. For classification of maturational stage, will held assessment of sexual maturation stages proposed by Tanner, determined by self-assessment of the stage of development of pubic hair, avoiding major constraint adolescents. Intervention with exercise: The groups will perform physical training activities three times a week after school for 12 weeks, with interval training sessions varying intensities according to the scale of perceived exertion Borg, with duration ranging between 24 and 32 minute main part. Classes will taught by a physical education teacher with the aid of monitors, area students. Nutrition education classes will held at the school, by nutritionist, with a weekly, totaling 12 meetings. Training Protocol Both trainings will be conducted simultaneously with each group in their midst, in order to avoid possible interference on the voice command, ambient temperature, relative humidity and time of accomplishment from training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Obesity
    Keywords
    Overweight, Obesity, Cardiometabolic risk factors, Adolescents, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Jump exercise
    Arm Type
    Experimental
    Arm Description
    rebound exercises.
    Arm Title
    Aquatic exercise
    Arm Type
    Experimental
    Arm Description
    Hydrogimnastic.
    Arm Title
    Nutritional guidance
    Arm Type
    Active Comparator
    Arm Description
    Nutritional counseling classes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Jump exercise
    Other Intervention Name(s)
    Rebound exercises
    Intervention Description
    Land Group / Jump (LG): Will hold weekly classes of nutritional guidance and three weekly sessions of jump, for 12 weeks, divided into warm up, main aerobics and relaxation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aquatic exercise
    Other Intervention Name(s)
    Hydrogimnastic
    Intervention Description
    Group Water / Water aerobics (WG): Will hold weekly classes of nutritional guidance and three weekly sessions of water, for 12 weeks, divided into warm up, main aerobics and relaxation.
    Intervention Type
    Other
    Intervention Name(s)
    Nutritional guidance
    Other Intervention Name(s)
    Nutritional counseling
    Intervention Description
    Control Group (CG): take part only of weekly classes of nutritional guidance, in addition to a closed group on Facebook in order to encourage them and increase attention to the group.
    Primary Outcome Measure Information:
    Title
    Body Mass Index
    Time Frame
    baseline, 12th week
    Secondary Outcome Measure Information:
    Title
    Waist circumference
    Time Frame
    baseline, 12th week
    Title
    Blood Pressure
    Time Frame
    baseline, 12th week
    Title
    HDL-cholesterol
    Time Frame
    baseline, 12th week
    Title
    Triglycerides
    Time Frame
    baseline, 12th week
    Title
    Fasting glycemia
    Time Frame
    baseline, 12th week
    Title
    Body Fat Percentage
    Description
    Bioeletrical Impedance
    Time Frame
    baseline, 12th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pubescent and post-pubescent adolescents are included, of both gender, who have overweight or obese, and waist / height ratio greater than 0.50 Without disabling the practice of physical exercise conditions and not using medications that may affect the outcome of the present study, such as medications to control cholesterol for hormone treatments and diuretics Exclusion Criteria: Those adolescents who become pregnant during the training will be deleted
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beatriz D Schaan, PhD
    Organizational Affiliation
    Federal University of Rio Grande do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity

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