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

November 22, 2020 updated by: Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Universiti Tunku Abdul Rahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SIT for males
Other: SIT
Sprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles.
Experimental: SIT for females
Other: SIT
Sprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
BMI for change
Time Frame: At baseline (before intervention begin) and post training (end of 6 weeks).
At baseline (before intervention begin) and post training (end of 6 weeks).
Waist Circumference for change
Time Frame: At baseline (before intervention begin) and post training (end of 6 weeks).
At baseline (before intervention begin) and post training (end of 6 weeks).
Total Fat % for change
Time Frame: At baseline (before intervention begin) and post training (end of 6 weeks).
At baseline (before intervention begin) and post training (end of 6 weeks).
Lean Muscle Mass for change
Time Frame: At baseline (before intervention begin) and post training (end of 6 weeks).
At baseline (before intervention begin) and post training (end of 6 weeks).
skin Fold Measurement for change
Time Frame: At baseline (before intervention begin) and post training (end of 6 weeks).
At baseline (before intervention begin) and post training (end of 6 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Tunku Abdul Rahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMFB1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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