AzTrials
AzTrials

Overweight and ObesityNCT03972059

High Intensity Interval Circuit Training on Resting Metabolic Rate in Overweight Adults

A study testing Exercise training - Phase 1, Exercise training - Phase 2 and Exercise training - Phase 3 in people with Overweight and Obesity, run by University of Thessaly at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is the first study to examine changes in resting metabolic rate up to 72 hours following an exercise session, and how these changes may be affected by 12 weeks of high intensity interval circuit training (HIICT). Read more about this study

Who is it for?
Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Exercise training - Phase 1, Exercise training - Phase 2 and Exercise training - Phase 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGreece
Study dates
8 Apr 2019to 20 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Overweight or class I obesity (BMI: 25-35 kg/m^2)
  • Sedentary lifestyle
  • Willing to lose weight
  • Individuals at low risk of various cardiovascular, pulmonary, renal, and metabolic diseases as well as other conditions (e.g., pregnancy and orthopedic injury) that require special attention when developing the exercise prescription (Thompson et al., 2013). This risk classification indicates that participants will be able to participate in moderate intensity exercise [40-60% oxygen uptake reserve (VO2R); 3-6 metabolic equivalent of task (METs)] and also in vigorous intensity exercise (>60% VO2R; >6 METs) while medical examination, exercise test and physician supervision are not recommended in the preparticipation health screening process.

Who cannot join

  • Following a diet plan or taking dietary supplements over the last 6 months and during the intervention
  • Participation in another training program over the last 6 months and during the intervention
  • Family history of coronary heart disease
  • Recent musculoskeletal injury

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • SmArT LABORATORY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES, UNIVERSITY OF THESSALY

    Trikala, 42100

Other trials in Greece

About this study

Official title: The Effect of High Intensity Interval Circuit Training With Portable Equipment on Changes in Resting Metabolic Rate in Overweight Adults

This is the first study to examine changes in resting metabolic rate up to 72 hours following an exercise session, and how these changes may be affected by 12 weeks of high intensity interval circuit training (HIICT). Various training programs that have been implemented in previous studies have investigated changes in resting metabolic rate only for the first 2-8 hours following an exercise session.

Briefly, the results of this study will provide insight into the following:

  1. To what extent and for how long does HIICT increases the resting metabolic rate following an exercise session?
  2. How can this exercise program enhance metabolism without any dietary or other exercise intervention?
  3. What is the caloric deficit that will result from 3 months of HIICT and how to what extent this deficit will influence body weight reduction?
Read the detailed description

According to the World Health Organization, overweight and obesity are defined as as abnormal or excessive fat accumulation, that presents a risk to health. Body Mass Index (BMI) is a useful population-level measure of overweight and obesity in adults, defined as follows: BMI = [weight (kg)] / [height (m)^2]. Individuals with BMI>25 kg/m^2 are considered overweight, whereas individuals with BMI>30 are considered obese. The higher the BMI, the greater the risk of developing non-communicable diseases, such as cardiovascular disease, diabetes mellitus and various forms of cancer. Obesity is now the most widespread disease in the developed world. It has been estimated that over 1.9 billion adults (39% of the population) are overweight, of whom 600 million (13% of the population) are obese. These rates are translated into a significant economic impact on a county's health care system; therefore, drastic measures are needed. The major cause of obesity is an energy imbalance between caloric intake and energy expenditure in favor of the former. Thus, changes in lifestyle that affect the energy balance, such as participation in an exercise program, can reduce body weight and, therefore, contribute to obesity treatment.

The recommendation of physical activity for significant weight loss involves prolonged exercise of moderate to high intensity that gradually increases to ~250 minutes/week. Resistance training is also recommended as it activates the neuromuscular system and can improve functional ability. On the other hand, High Intensity Interval Training (HIIT), which mainly involves a cardiovascular exercise strategy alternating short periods of intense anaerobic exercise with less intense recovery periods, are proposed because they are time-efficient. In addition, HIIT improves aerobic capacity and body composition, which is related to resting metabolic rate and mitochondrial metabolism of skeletal muscle in both healthy and overweight and obese adults. Changes caused by HIIT in mitochondrial function may explain the greater efficacy in inducing positive metabolic adaptations compared to traditional endurance or resistance protocols, even when not accompanied by dietary weight loss strategies.

Resting metabolic rate is defined as the energy expenditure required to maintain the normal physiological processes of the body at rest and accounts for 60-75% of the total daily energy expenditure. Small increases in resting metabolic rate could long-term positive effects on weight management. Energy expenditure is increased not only during exercise, but also for some hours post-exercise. To date, it has been observed that this increase in resting metabolic rate can last for up to 48 hours following an exercise session, especially following resistance training. More specifically, in a study where 7 women (22-35 years old) participated in a resistance training program (100 minutes/session, 10 exercises of 5 sets with 10-15 repetitions per set), there was an increase in their resting metabolic rate by 13% at the first 3 hours and an increase by 4.2% at 16 hours following an exercise session. On the other hand, a 10-week (3 session/week) strength training program with an intensity of 65-85% of the maximum heart rate based on age (gradual increase in intensity), did not appear to cause any changes in resting metabolic rate following an exercise session. However, in another study where resistance training (strength protocol of 3 sets with 10-15 repetitions per set at the beginning of intervention up to 4-8 repetitions at the end of the intervention) was combined with endurance training (65% to 85% with an intensity of 65-85% of the maximum heart rate based on age, of increasing intensity), it was observed that resting metabolic rate increased following an exercise session.

It is important to note that, according to the available literature, it has been shown that training studies have been examined changes in resting metabolic rate only up to 2-8 hours following an exercise session. Therefore, the aim of the present study is to investigate the effect of a 12-week HIICT protocol with portable equipment on changes in resting metabolic rate 24, 48 and 72 hours following an exercise session.

Flow of the research design:

  1. Baseline: Anthropometric and physiological measurements (including a Resting Metabolic Rate (RMR) measurement following an overnight fast).
  2. One-week familiarization period: Volunteers will participate in two exercise sessions in order to learn the right techniques. RMR will be measured 24, 48 and 72 hours following the last exercise session. Moreover, participants will be given instructions and then they will record their diet for 3 days (2 week days and one weekend day).
  3. Initiation of the 12-week HIICT program: The program will be supervised and portable training equipment will be used. There will be 3 exercise sessions per week (Monday-Wednesday-Friday). The program will be divided into 3 phases (4 weeks each phase), where exercise intensity will increase gradually.
  4. 1st phase: RMR will be measured 24 hours before, as well as 24, 48 and 72 hours following the last exercise session of the phase (e.g. at the end of the 4th week of the program). Anthropometric and physiological measurements will also be conducted. Moreover, participants will record their diet for 3 days (2 week days and one weekend day).
  5. 2nd phase: Exercise intensity will increase. The same measurements with phase 1 will be conducted.
  6. 3rd phase: Exercise intensity will increase. The same measurements with phases 1 and 2 will be conducted.
Being tested
Exercise training - Phase 1, Exercise training - Phase 2, Exercise training - Phase 3
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training - Phase 1Other

    Phase 1 is the first 4 weeks of the 12-week training program.

  • Exercise training - Phase 2Other

    Phase 2 is the next 4 weeks following phase 1 of the 12-week training program. The exercise intensity during exercise bouts in this phase is increased compared to the exercise intensity applied in phase 1.

  • Exercise training - Phase 3Other

    Phase 3 is the last 4 weeks of the 12-week training program. The exercise intensity during exercise bouts in this phase is increased compared to the exercise intensity applied in the previous phases.

Study groups in NCT03972059
Study groupRoleWhat they receive
Experimental groupExperimentalA 12-week high intensity interval circuit training program for weight management in overweight adults.
Receives: Other: Exercise training - Phase 1; Other: Exercise training - Phase 2; Other: Exercise training - Phase 3
Control groupNo interventionNo intervention for 12 weeks, participants perform all tests.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resting metabolic rate (kilocalories)

    Resting metabolic rate following 12 hours of an overnight fast

    Measured: At baseline

  2. Resting metabolic rate (24 before an exercise bout) (kilocalories)

    Changes in resting metabolic rate 24 before an exercise bout

    Measured: Pre-intervention, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  3. Resting metabolic rate (24 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 24 following an exercise bout

    Measured: Pre-intervention, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  4. Resting metabolic rate (48 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 48 following an exercise bout

    Measured: Pre-intervention, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  5. Resting metabolic rate (72 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 72 following an exercise bout

    Measured: Pre-intervention, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  6. Body fat mass (kilograms)

    Changes in body fat mass measured with dual-energy x-ray absorptiometry (DEXA)

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  7. Body lean mass (kilograms)

    Changes in body lean mass measured with dual-energy x-ray absorptiometry (DEXA)

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  8. Bone mass (kilograms)

    Changes in bone mass measured with dual-energy x-ray absorptiometry (DEXA)

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

Secondary outcomes (5)
  1. Waist to hip ratio (WHR)

    WHR is calculated by dividing waist circumference by hip circumference

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  2. Lower limb strength

    Leg press (10 Repetition Maximum - RM)

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  3. Upper body strength

    Chest press (10 Repetition Maximum - RM)

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  4. Aerobic capacity test

    Ebbeling submaximal treadmill walking test

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

  5. Maximal abdominal muscle endurance

    Maximal repetition till exhaustion

    Measured: At baseline, 24 hours after completion of phase 1, 24 hours after completion of phase 2, 24 hours after completion of phase 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start8 Apr 2019
  3. Primary completion20 Jul 2019
  4. Study completion20 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The 12-week training program will be divided into 3 phases (4 weeks each phase). Completion of each phase means that the subjects have increased their physical fitness and will get to the next phase where the intensity of exercise will increase in order to gain more physical fitness benefits (e.g. increased caloric expenditure). There will be a control group as well, where participants will not participate in any intervention.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03972059
Sponsor's protocol ID
HIICT-RMR study
Status last verified
Nov 2019
First submitted
23 May 2019
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training - Phase 1, Exercise training - Phase 2 and Exercise training - Phase 3 in people with Overweight and Obesity, run by University of Thessaly at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resting metabolic rate (kilocalories) (time frame: At baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in