NCT03134781

Brief Summary

In this study the investigators utilized a novel hybrid HIIT (high intensity interval training) exercise training approach, the Hybrid Interval Training (DoIT) workout that combines interval training, resistance exercise training and functional training in order to test the hypothesis that DoIT will be able to: i) reduce body mass, ii) improve body composition and iii) alter energy balance, of previously inactive, overweight/obese women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

April 26, 2017

Last Update Submit

October 25, 2021

Conditions

Outcome Measures

Primary Outcomes (10)

  • Change in body mass

    At baseline, at 20 weeks and at 40 weeks.

  • Change in body mass index

    At baseline, at 20 weeks and at 40 weeks.

  • Change in waist circumference

    At baseline, at 20 weeks and at 40 weeks.

  • Change in hip circumference

    At baseline, at 20 weeks and at 40 weeks.

  • Change in waist-to-hip ratio

    At baseline, at 20 weeks and at 40 weeks.

  • Change in body fat.

    Body fat assessed by whole-body dual-energy X-ray absorptiometry (DXA).

    At baseline, at 20 weeks and at 40 weeks.

  • Change in fat mass

    Fat mass assessed by whole-body dual-energy X-ray absorptiometry (DXA).

    At baseline, at 20 weeks and at 40 weeks.

  • Change in fat-free mass

    Fat-free mass assessed by whole-body dual-energy X-ray absorptiometry (DXA).

    At baseline, at 20 weeks and at 40 weeks.

  • Change in resting metabolic rate

    Measured using a portable open-circuit indirect calorimeter with a ventilated hood system.

    At baseline, at 20 weeks and at 40 weeks.

  • Change in exercise-induced caloric expenditure.

    Measured using a portable indirect calorimetry system

    At baseline, at 20 weeks and at 40 weeks.

Secondary Outcomes (5)

  • Change in maximal strength (1RM)

    At baseline, at 20 weeks and at 40 weeks.

  • Change in maximal oxygen consumption (VO2max)

    At baseline, at 20 weeks and at 40 weeks.

  • Change in blood lactate concentration

    Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.

  • Change in habitual physical activity

    At baseline, at 20 weeks and at 40 weeks.

  • Change in dietary intake

    At baseline, at 20 weeks and at 40 weeks.

Study Arms (3)

Control

EXPERIMENTAL

Participated only in measurements at baseline, at 20 weeks and at 40 weeks.

Behavioral: Control - No training

Training

EXPERIMENTAL

Participated in a supervised 40-week DoIT workout exercise training program and in measurements at baseline, at 20 weeks and at 40 weeks.

Behavioral: DoIT workout

Training-Detraining

EXPERIMENTAL

Participated in a supervised 20-week DoIT workout exercise training program and then entered a 20-week detraining period. They also participated in measurements at baseline, at 20 weeks and at 40 weeks.

Behavioral: DoIT workout - Detraining

Interventions

DoIT workoutBEHAVIORAL

A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management. FFIT was performed 3 times/week with 48 hours recovery between sessions for 40 weeks.

Training

A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training, performed according to a periodized model of exercise prescription for a 20-week period (3 times/week). Immediately after a 20-week detraining period (no training was performed) was followed.

Training-Detraining

No training was performed during a 40-week period. Participation only in measurements.

Control

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (a) were sedentary (\<7,500 steps/day; VO2max \<30 ml/kg/min), b) premenopausal women aged 30-45 years, c) were overweight or obese class 1 (BMI=25-34.9 kg/m2), d) were non-smokers for ≥6 months before the study, e) not following a diet intervention or using nutritional supplements/medications before (≥6 months) and during the study, f) had no weight loss greater \>10% of body mass ≤6 months before the study, g) participated in ≥80% of total exercise sessions, and h) had no symptoms of depression.

You may not qualify if:

  • a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma, d) signs, symptoms or diagnosis of serious health complications or physical disability or other medical condition compromising safe participation in exercise training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, Karies, 42100, Greece

Location

Related Publications (5)

  • Batrakoulis A, Jamurtas AZ, Georgakouli K, Draganidis D, Deli CK, Papanikolaou K, Avloniti A, Chatzinikolaou A, Leontsini D, Tsimeas P, Comoutos N, Bouglas V, Michalopoulou M, Fatouros IG. High intensity, circuit-type integrated neuromuscular training alters energy balance and reduces body mass and fat in obese women: A 10-month training-detraining randomized controlled trial. PLoS One. 2018 Aug 23;13(8):e0202390. doi: 10.1371/journal.pone.0202390. eCollection 2018.

  • Batrakoulis A, Loules G, Georgakouli K, Tsimeas P, Draganidis D, Chatzinikolaou A, Papanikolaou K, Deli CK, Syrou N, Comoutos N, Theodorakis Y, Jamurtas AZ, Fatouros IG. High-intensity interval neuromuscular training promotes exercise behavioral regulation, adherence and weight loss in inactive obese women. Eur J Sport Sci. 2020 Jul;20(6):783-792. doi: 10.1080/17461391.2019.1663270. Epub 2019 Sep 16.

  • Batrakoulis A, Tsimeas P, Deli CK, Vlachopoulos D, Ubago-Guisado E, Poulios A, Chatzinikolaou A, Draganidis D, Papanikolaou K, Georgakouli K, Batsilas D, Gracia-Marco L, Jamurtas AZ, Fatouros I. Hybrid neuromuscular training promotes musculoskeletal adaptations in inactive overweight and obese women: A training-detraining randomized controlled trial. J Sports Sci. 2021 Mar;39(5):503-512. doi: 10.1080/02640414.2020.1830543. Epub 2020 Oct 15.

  • Batrakoulis A, Jamurtas AZ, Draganidis D, Georgakouli K, Tsimeas P, Poulios A, Syrou N, Deli CK, Papanikolaou K, Tournis S, Fatouros IG. Hybrid Neuromuscular Training Improves Cardiometabolic Health and Alters Redox Status in Inactive Overweight and Obese Women: A Randomized Controlled Trial. Antioxidants (Basel). 2021 Oct 12;10(10):1601. doi: 10.3390/antiox10101601.

  • 2020 NSCA Research Abstracts. J Strength Cond Res. 2021 Apr 1;35(4):e3-e288. doi: 10.1519/JSC.0000000000003877. No abstract available.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

April 1, 2017

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations