NCT03972059

Brief 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). 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. 1.To what extent and for how long does HIICT increases the resting metabolic rate following an exercise session?
  2. 2.How can this exercise program enhance metabolism without any dietary or other exercise intervention?
  3. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

May 23, 2019

Last Update Submit

November 4, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • Resting metabolic rate (kilocalories)

    Resting metabolic rate following 12 hours of an overnight fast

    At baseline

  • Resting metabolic rate (24 before an exercise bout) (kilocalories)

    Changes in resting metabolic rate 24 before an exercise bout

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

  • Resting metabolic rate (24 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 24 following an exercise bout

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

  • Resting metabolic rate (48 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 48 following an exercise bout

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

  • Resting metabolic rate (72 following an exercise bout) (kilocalories)

    Changes in resting metabolic rate 72 following an exercise bout

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

  • Body fat mass (kilograms)

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

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

  • Body lean mass (kilograms)

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

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

  • Bone mass (kilograms)

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

    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)

  • Waist to hip ratio (WHR)

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

  • Lower limb strength

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

  • Upper body strength

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

  • Aerobic capacity test

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

  • Maximal abdominal muscle endurance

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

Study Arms (2)

Experimental group

EXPERIMENTAL

A 12-week high intensity interval circuit training program for weight management in overweight adults.

Other: Exercise training - Phase 1Other: Exercise training - Phase 2Other: Exercise training - Phase 3

Control group

NO INTERVENTION

No intervention for 12 weeks, participants perform all tests.

Interventions

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

Experimental group

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.

Experimental group

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.

Experimental group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trikala, 42100, Greece

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ioannis G Fatouros, PhD

    SmArT Lab, DPESS, University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 3, 2019

Study Start

April 8, 2019

Primary Completion

July 20, 2019

Study Completion

August 20, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations