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Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
SIT
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI≧23kg/m2(WHO for Asia-Pacific region)
  • No history of metabolic, hormonal, orthopedic, or cardiovascular diseases
  • No current use of prescribed medication including oral contraception

Exclusion Criteria:

  • Contraindications to physical activity assessed by Physical Activity Readiness Questionnaire-PAR-Q
  • Undergoes any surgical or hormone treatment

Sites / Locations

  • Universiti Tunku Abdul Rahman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SIT for males

SIT for females

Arm Description

Outcomes

Primary Outcome Measures

BMI for change
Waist Circumference for change
Total Fat % for change
Lean Muscle Mass for change
skin Fold Measurement for change

Secondary Outcome Measures

Full Information

First Posted
November 4, 2019
Last Updated
November 22, 2020
Sponsor
Universiti Tunku Abdul Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT04155827
Brief Title
Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training
Official Title
Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training on Anthropometric Variables
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman

4. Oversight

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

5. Study Description

Brief Summary
Overweight and Obesity is a growing health problem worldwide. Lifestyle changes such as decreased physical activity, increased sedentary behaviour and unhealthy eating habits has contribute to this problem. According to World Health Organization (2016), more than 1.9 billion adults aged 18 years and older were overweight (39% of men and 40% of women).Regular exercise is the key contributor to energy expenditure and is essential for energy balance and weight control. Interval training (IT) has been commonly used for decades with purpose to improve body health and reduce weight loss and this exercise differs from the conventional aerobic exercise and endurance exercise as IT typically involves repeated bouts of relatively intense exercise interspersed by periods of lower- intensity effort or complete rest for recovery. One of the most common type of IT is sprint interval training (SIT). SIT involves 'supramaximal' effort (>100% VO2max) work bouts, traditionally structured as four to six 30s all-out effort and each round separated by 4 minutes of recovery period of a low intensity exercise. Potential physiological adaptation of SIT are highlighted by various studies reporting cardiovascular, skeletal muscle adaptations, increase fat oxidation that facilitate increases in both aerobic and anaerobic performance. In addition, SIT is able to improve maximal rate of oxygen consumption (VO2max), at the same time improving the peripheral vascular structure and function, enzymes of fat metabolism and increases insulin sensitivity. Previous SIT studies have included young healthy men and women, healthy obese young women, all of which have shown that SIT is effective for fat loss and improvement of some health parameters. However, whether SIT protocol is equally effective in improving the anthropometric measures in men and women remain unknown.
Detailed Description
Total of 80 eligible male (n=40) and female (n=40) young adults will be equally recruited using block randomization and chosen based on the inclusion and exclusion criteria. Before the study, all participants will be informed of the potential risks and benefits of the study. During the study period, participants will be instructed to avoid any form of physical activity besides the study protocol. Both groups will perform SIT protocol on a electromagnetically braked cycle ergometer three times per week for 6 weeks. Every session, participants start with a 5 minutes warm up at 50- 60% of heart rate maximum (HRmax) and follow by four 30-s all out bouts intersperse with 4 minutes of recovery (passive or no load cycling). For confirmation of all-out effort, participant are required to maintain his or her cycling cadence at least 60 rpm or above. Intervention will end with a 5 minutes cool down at 50- 60% of HRmax. Total duration for each session will be 28 minutes. If a participant misses fewer than three sessions per week non- consecutively, the sessions missed will be replace at the end of period. However, if participants misses three or more sessions, he or she will be excluded from the study. Outcome measures will be assessed at baseline and at end of 6 weeks of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SIT for males
Arm Type
Experimental
Arm Title
SIT for females
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
SIT
Intervention Description
Sprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles.
Primary Outcome Measure Information:
Title
BMI for change
Time Frame
At baseline (before intervention begin) and post training (end of 6 weeks).
Title
Waist Circumference for change
Time Frame
At baseline (before intervention begin) and post training (end of 6 weeks).
Title
Total Fat % for change
Time Frame
At baseline (before intervention begin) and post training (end of 6 weeks).
Title
Lean Muscle Mass for change
Time Frame
At baseline (before intervention begin) and post training (end of 6 weeks).
Title
skin Fold Measurement for change
Time Frame
At baseline (before intervention begin) and post training (end of 6 weeks).

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Both genders (male & female) will be equally recruited.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI≧23kg/m2(WHO for Asia-Pacific region) No history of metabolic, hormonal, orthopedic, or cardiovascular diseases No current use of prescribed medication including oral contraception Exclusion Criteria: Contraindications to physical activity assessed by Physical Activity Readiness Questionnaire-PAR-Q Undergoes any surgical or hormone treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imtiyaz Ali Mir
Organizational Affiliation
Universiti Tunku Abdul Rahman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Tunku Abdul Rahman
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Gender Specific Responses of Overweight and Obese Adults to Sprint Interval Training

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