"COMPARATIVE EFFECTS of REDUCED EXERTION HIGH INTENSITY TRAINING (REHIT) VERSUS HIGH INTENSITY INTERVAL TRAINING (HIIT) on ANTHROPOMETRIC MEASURES in OVERWEIGHT and OBESE ADULTS"

September 20, 2024 updated by: Foundation University Islamabad
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined. Hence the objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and cardiorespiratory fitness in overweight and obese adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined.The significance of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) and will also investigate the effectiveness of REHIT as an alternative for overweight and obese individuals who perceive HIIT as too demanding. If found effective, it can also help in providing training protocol for optimizing cardiovascular health in this population, potentially leading to improved outcomes and reduced healthcare burdens. The results of this study will also add data to literature regarding the effects of REHIT and HIIT on anthropometric measures in overweight and obese. Main objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus HIIT on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and Cardiorespiratory fitness in overweight and obese individuals. The participants meeting the eligibility criteria will be recruited followed by random allocation to one of the 2 groups, following which they will be required to complete a self-reported demographic form and will be screened using Physical Activity Readiness Questionnaire (PAR-Q). Baseline evaluation will be done using tape measure for anthropometric, assessment of waist circumference and hip circumference, CUN-BAE index for adiposity and Queen's College step test for cardio-respiratory fitness. Experimental group A will perform REHIT while experimental group B will perform HIIT. Participants will also be provided with dietary restriction plan that will be followed during the training protocol. Exercise training would be performed for consecutive 6 weeks, 3 times a week on alternative days for total of 18 sessions.

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 (Estimated)

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.
42

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

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Foundation University College of Physical Therapy

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Both male and female adults aged 18-45 years
  • Overweight individuals with BMI ≥ 23kg/m²- 24.9kg/m²
  • Obese individuals with BMI ≥ 25kg/m²
  • Individuals falling in low PA category as per IPAQ Exclusion Criteria
  • Individuals with any diagnosed cardiovascular, metabolic or pulmonary disease
  • Current neurological or musculoskeletal conditions which limit participation in the study
  • Any active infections
  • Those with any contraindication to exercise testing or training.
  • Currently following any dietary restriction plans for weight loss

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: 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: Reduced Exertion High intensity Training (REHIT) Group
Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer.A 3-minute cool-down period will conclude each session. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration.
Other: Reduced Exertion High Intensity Training (REHIT)
Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer. Each session will consist of a 3-minute warm-up period followed by two 20-second all-out sprints interspersed with 3 minutes of slow pedaling for recovery. Total of 18 sessions of REHIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.
Experimental: High Intensity Interval Training (HIIT)
Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration.
Other: High Intensity Interval Training (HIIT)
Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Week 1 will be baseline fitness level and familiarization week. Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Pre and post session vitals will be noted. Total of 18 sessions of either HIIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.

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
Measure Description
Time Frame
Waist circumference
Time Frame: 6 weeks
Will be measured using a cloth tape measure. Waist circumference will be measured at the level of the smallest circumference above the umbilicus and below the xiphoid appendix.
6 weeks
Hip Circumference:
Time Frame: 6 weeks
Measure at the widest point of the hips, with feet together
6 weeks
Waist-to-hip Ratio:
Time Frame: 6 weeks
To determine the waist-to-hip ratio, divide the WC by the HC
6 weeks
Cardiorespiratory fitness
Time Frame: 6 weeks
Cardiorespiratory Fitness will be assessed via Queens College step test.
6 weeks
Adiposity index
Time Frame: 6 weeks
Evaluation will be done using CUN-BAE INDEX (Clínica Universidad de Navarra-Body Adiposity Estimator)
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.
Foundation University Islamabad

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.
June 10, 2024

Primary Completion (Estimated)

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.
December 10, 2024

Study Completion (Estimated)

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.
December 30, 2024

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).
September 20, 2024

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.
September 20, 2024

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.
September 24, 2024

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.
September 24, 2024

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.
September 20, 2024

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.
August 1, 2024

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.
  • FUI/CTR/2024/26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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