NCT02798666

Brief Summary

Background and aims: The purpose of this study was to evaluate the effect of high intensity interval training (HIIT) on body composition, physical fitness, metabolic fitness and muscle histology in men with overweight or obesity compared to continuous aerobic training (CAT). Material and methods: 16 male participants with overweight/obesity (age range: 42 - 57 years, body mass index: 28 - 36 kg/m²) were randomized to HITT (n=8) or CAT (n=8). HIIT was composed of two sprint blocks of 10 minutes at ventilatory threshold (VT), within between a continuous block of 10 minutes, twice a week for 15 weeks. CAT was composed of three blocks of 10 minutes continuous endurance training at VT. After 5 weeks, intensity was increased to 110% of VT. Changes in body composition, physical fitness (peakVO2 and anaerobic threshold (AT)), basal respiratory exchange ratio (bRER) and insulin sensitivity by oral glucose tolerance test were evaluated. Mitochondrial content was evaluated by transmission electron microscopy (TEM) in muscle biopsies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

May 31, 2016

Last Update Submit

December 12, 2023

Conditions

Keywords

Physical fitnessRespiratory exchange ratioInsulin sensitivityHigh intensity interval trainingContinuous exercise training

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity measured by oral glucose tolerance test

    Baseline and 10 weeks (end of intervention)

Secondary Outcomes (5)

  • Respiratory exchange ratio measured by ergospirometry at rest

    Baseline and 10 weeks (end of intervention)

  • muscle fiber fat content measured by transmission electron microscopy in muscle biopsy

    Baseline and 10 weeks (end of intervention)

  • muscle fiber mitochondrial content measured by transmission electron microscopy in muscle biopsy

    Baseline and 10 weeks (end of intervention)

  • PeakVO2 measured by ergospirometry during maximal exercise testing

    Baseline and 10 weeks (end of intervention)

  • Ventilatory threshold measured by ergospirometry during maximal exercise testing

    Baseline and 10 weeks (end of intervention)

Other Outcomes (3)

  • Weight measured by weight scale

    Baseline and 10 weeks (end of intervention)

  • Heigth measured by stadiometer

    Baseline and 10 weeks (end of intervention)

  • BMI

    Baseline and 10 weeks (end of intervention)

Study Arms (2)

High intensity exercise training

EXPERIMENTAL

The participants exercised for 40 minutes, twice a week, under supervision of two physiotherapists for in total 10 weeks. Each training session included a warming up, a sprint interval block \[10 minutes\], continuous aerobic exercise \[10 minutes\], another sprint interval block \[10 minutes\] and cooling down. For the first 5 weeks, each sprint interval block consisted of 10 sprint bouts \[\>100 r/min\] of 15 seconds at a cycling resistance matching with the ventilatory threshold \[VTR\], alternated with 45 seconds relative rest \[50 r/min at VTR\]. Starting from week 6 until week 10, the intensity of sprinting and relative rest was increased up to 110% of VTR.

Other: High intensity exercise training

Continuous exercise training

ACTIVE COMPARATOR

The comparative group performed a continuous aerobic training \[CAT\] for 10 weeks, twice a week and 40 minutes per session \[volume and frequency is equal to HIIT\]. The protocol of the CAT group consisted of warming up \[stretching of the large muscle groups and cardiovascular exercises at 30% of peak cycling power output for five minutes\], continuous aerobic exercise training \[3 times 10 minutes\] and cooling down \[stretching of the large muscle groups and cardiovascular exercises at 30% of peak cycling power output for five minutes\]. During the continuous aerobic protocol \[cycling or stepping\] participants exercised for 10 minutes at a HR similar to the HR at VT \[60 r/min\], which was increased to 110% of VT from week 6 onwards.

Other: Continuous exercise training

Interventions

Exercise training using sprint interval exercise

Also known as: HIT
High intensity exercise training

Exercise training using continuous exercise at constant heart rate

Also known as: CAT
Continuous exercise training

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 27 and 35

You may not qualify if:

  • Diabetes (HbA1c\>6,5%),
  • severe musculoskeletal (eg osteoarthritis),
  • cardiovascular (eg chronic heart failure) or respiratory (eg chronic obstructive pulmonary disease (COPD)) problems based on medical files.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cochran AJ, Percival ME, Tricarico S, Little JP, Cermak N, Gillen JB, Tarnopolsky MA, Gibala MJ. Intermittent and continuous high-intensity exercise training induce similar acute but different chronic muscle adaptations. Exp Physiol. 2014 May 1;99(5):782-91. doi: 10.1113/expphysiol.2013.077453. Epub 2014 Feb 14.

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Patrick Calders, Professor

    Department of Rehabilitation Sciences and Physiotherapy, Universtity of Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 14, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share