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High-intensity Interval Training on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Overweight Women.

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High-intensity interval training
Moderate-intensity continuous training
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women 18 to 44 years old, overweighted (BMI ≥ 25 kg / m2) who agree to participate by signing the informed consent, no more than 600 Met / physical activity min / wk (be quantified with the Global Physical Activity Questionnaire - GPAQ), and have less than 30 points on the self-esteem scale.

Exclusion Criteria:

  • History of uncontrolled noncommunicable diseases (hypothyroidism, diabetes, asthma and high blood pressure, cardiac arrhythmias), motor disorders or sensitive to hinder the exercise, consumption of anticoagulants, medication altering heart rate (beta-blockers, calcium antagonists, bronchodilators), steroid use, abuse of psychoactive substances, personal history of surgical procedures in the last three months, depressive disorders; pregnancy.

Sites / Locations

  • Universidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training

Moderate-intensity continuous training

Arm Description

Outcomes

Primary Outcome Measures

Change in self-esteem
Self-esteem will be measured by applying the Rosenberg self-esteem scale and according to the scores obtained, the individual will be classified as low self-esteem (<30 points) or normal (> 30 points). The internal consistency of the scale shows a Cronbach's alpha with values ranging between 0.83 and 0.88, and the reliability shows a test-retest correlation of 0.84. Therefore, there is high internal consistency and adequate temporal reliability. Supporting the validity (of construct and known groups) of the instrument.

Secondary Outcome Measures

Change in muscle mass
Muscle Mass will be quantified through an Omron® HBF510 bioelectrical impedance scale, which has a capacity of 0 to 150 kg, an accuracy of 100 gr for the calculation of weight.

Full Information

First Posted
February 12, 2019
Last Updated
June 6, 2019
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT03852043
Brief Title
High-intensity Interval Training on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Overweight Women.
Official Title
Effect of a HIIT Program Compared to MICT on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Women 18 to 44 Years Old With Overweight or Obesity, Over a Period of 8 Weeks: a Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Overweight and obesity are a public health problem for society, reflected by an increase in its prevalence worldwide, being more frequent in women and related to low levels of self-esteem, accumulation of subcutaneous fat and internal organs, reduction of muscle mass (MM) and basal metabolic rate (BMR). Women are more predisposed to present weight gain because they are metabolically less efficient, have greater food intake, greater physical inactivity, and genetic factors. The different methods of physical training used for weight control are continuous training (CT) and the high-intensity interval training (HIIT). Both CT and HIIT have shown benefits without finding superiority of any of these methods. Nevertheless, there is a trend to the use HIIT programs, since they are more time-efficient and supports their use to induce physiological and metabolic adaptations over time, since this is a barrier to adherence to exercise programs. Overweight and obesity causes individual alterations in body composition and exercise leads to increase in MM, increase in caloric expenditure during the training session and increase in BMR due to the onset of muscle growth, secondary to an increase in the activity of the mitochondrial enzymes (greater mitochondrial biogenesis in the muscle), adaptations that could depend on the type of exercise, its intensity and the volume of it, but it is not clear due to the lack of evidence regarding this. The primary objective of this study is to demonstrate that a HIIT program of short duration in a real-world setting has a standardized mean difference (SMD) higher than 0.84 in the improvement of self-esteem when comparing with a moderate-intensity continuous training (MICT) in women 18 to 44 years with overweight and obesity and low self-esteem, during eight weeks. The secondary objective is to demonstrate that a low-volume HIIT in a real-world setting improves MM in 2% compared with MICT during a period of eight weeks in women 18 to 44 years.
Detailed Description
Fifty women with low self-esteem will be randomly assigned to one of two training programs (MICT or HIIT) in a real-world setting. Both groups will perform three times a week for eight-weeks on alternate days. The women in each group will perform three workouts per week for a period of eight weeks. The moderate-intensity continuous training group will perform a training session of 40 min duration at an intensity between 65 and 75% of your HRmax. Women assigned to the group HIIT will perform a training session of 22 minutes of duration by performing intervals of high intensity between 90 and 95 % of the HRmax for 30 seconds in duration and with a recovery of one minute training at moderate intensity is between 50 and 60 % of the HRmax, doing 15 loads of 30 seconds at high intensity, with 60 seconds of recovery between loads at moderate intensity. At the beginning of each training session, both groups will complete strength exercises mainly including large muscle groups (hip, knees, and ankles) with Theraband® (blue color ) for 3 sets of 15 repetitions. All participants will be evaluated before initiating interventions and upon completion of the training program, after eight weeks, self-esteem will be assessed using the Rosenberg self-esteem scale, determination of anthropometric variables such as weight, height, waist circumference, arterial pressure, body composition by bioimpedance and the basal metabolic rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training
Arm Type
Experimental
Arm Title
Moderate-intensity continuous training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
The intervals of high intensity are conducted between 90 and 95 % of heart rate maximum (HRmax) and resting between 50 and 60 % of the HRmax 15 loads of 30 seconds at high intensity, with 60 seconds of recovery at loads of moderate intensity.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity continuous training
Intervention Description
The continuous training will be carried out at an intensity between 65 and 75% of the HRmax.
Primary Outcome Measure Information:
Title
Change in self-esteem
Description
Self-esteem will be measured by applying the Rosenberg self-esteem scale and according to the scores obtained, the individual will be classified as low self-esteem (<30 points) or normal (> 30 points). The internal consistency of the scale shows a Cronbach's alpha with values ranging between 0.83 and 0.88, and the reliability shows a test-retest correlation of 0.84. Therefore, there is high internal consistency and adequate temporal reliability. Supporting the validity (of construct and known groups) of the instrument.
Time Frame
Change from baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
Change in muscle mass
Description
Muscle Mass will be quantified through an Omron® HBF510 bioelectrical impedance scale, which has a capacity of 0 to 150 kg, an accuracy of 100 gr for the calculation of weight.
Time Frame
Change from baseline and after 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in basal metabolic rate
Description
Basal metabolic rate will be quantified at the beginning of the study and at the end through a portable gas analyzer model K4b2 (Cosmed Inc, IL, USA), the test will be performed between 7:00 - 7:30 am, the participant must have a fast of at least five hours, and abstaining from consuming products with caffeine and alcoholic beverages 12 hours prior to the evaluation. During the test, the participant must remain seated at rest in an isolated room for 15 minutes. The measurement of the resting metabolic rate will be made during the next 10 minutes in the same position. The criteria to determine a valid measurement will be: the stay in a minimum of 10 minutes in steady state, determined by: discarding the first five minutes of the measurement, reaching a coefficient of variation ≤10% for VO2 and for VCO2 during the ten minutes remaining and a respiratory quotient between 0.7 to 1.0.
Time Frame
Change from baseline and after 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women 18 to 44 years old, overweighted (BMI ≥ 25 kg / m2) who agree to participate by signing the informed consent, no more than 600 Met / physical activity min / wk (be quantified with the Global Physical Activity Questionnaire - GPAQ), and have less than 30 points on the self-esteem scale. Exclusion Criteria: History of uncontrolled noncommunicable diseases (hypothyroidism, diabetes, asthma and high blood pressure, cardiac arrhythmias), motor disorders or sensitive to hinder the exercise, consumption of anticoagulants, medication altering heart rate (beta-blockers, calcium antagonists, bronchodilators), steroid use, abuse of psychoactive substances, personal history of surgical procedures in the last three months, depressive disorders; pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elkin F Arango, MD. MsC
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High-intensity Interval Training on the Self-esteem, Basal Metabolic Rate and Muscle Mass in Overweight Women.

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