- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134781
Hybrid Exercise Training for Weight Loss (DoIT)
October 25, 2021 updated by: Ioannis G. Fatouros, University of Thessaly
The Effects of a Novel Hybrid Exercise Training Program on Body Composition, Body Weight and Energy Balance in Sedentary Overweight/Obese Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a controlled randomized, two-group, repeated measures design, 65 healthy, sedentary, premenopausal overweight or obese women were randomly assigned to one of three groups: (a) a control group (C, N=21) that participated only in measurements, (b) a training group (TR, N=14) that participated in a supervised 40-week DoIT workout exercise training program and (c) a training-detraining group (TRD, N=14).
During the first 20 weeks, TR and TRD followed exactly the same training protocol.
At the end of this period, TR continued training for 20 more weeks whereas TRD terminated training for 20 weeks (detraining).
Anthropometric, metabolic, daily nutritional intake, habitual physical activity and performance measurements were performed in all groups at baseline, at 20 weeks and 40 weeks.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- 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
-
-
Karies
-
Trikala, Karies, Greece, 42100
- Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
-
-
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
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- 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.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
Participated only in measurements at baseline, at 20 weeks and at 40 weeks.
|
No training was performed during a 40-week period.
Participation only in measurements.
|
|
Experimental: Training
Participated in a supervised 40-week DoIT workout exercise training program and in measurements at baseline, at 20 weeks and at 40 weeks.
|
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.
|
|
Experimental: Training-Detraining
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body mass
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in body mass index
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in waist circumference
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in hip circumference
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in waist-to-hip ratio
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in body fat.
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
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
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
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
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
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
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
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.
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
Measured using a portable indirect calorimetry system
|
At baseline, at 20 weeks and at 40 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in maximal strength (1RM)
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
Measured bilaterally on a horizontal leg press.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
Change in maximal oxygen consumption (VO2max)
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
Assessed by a portable open-circuit spirometry system.
|
At baseline, at 20 weeks and at 40 weeks.
|
|
Change in blood lactate concentration
Time Frame: Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
|
Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
|
|
|
Change in habitual physical activity
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
Seven-day habitual physical activity was assessed by accelerometry
|
At baseline, at 20 weeks and at 40 weeks.
|
|
Change in dietary intake
Time Frame: At baseline, at 20 weeks and at 40 weeks.
|
Assessed using 7-day diet recalls
|
At baseline, at 20 weeks and at 40 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: PLoS One. 2020 Oct 13;15(10):e0240945.
- 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 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)
July 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
April 26, 2017
First Submitted That Met QC Criteria
April 26, 2017
First Posted (Actual)
May 1, 2017
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DoIT-UTH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Body Composition
-
Efforia, IncRecruiting
-
Dynamical Business and Science Society - DBSS International...Universidad de Córdoba; CES University; ARTHROS Centro de Fisioterapia y EjercicioRecruiting
-
Nova Southeastern UniversityCompleted
-
Centro Universitario de Ciencias de la Salud, MexicoCompleted
-
University of Southern CaliforniaCompleted
-
University of California, San FranciscoHologic, Inc.Completed
-
University of SurreyUnknownBody Composition
-
Texas Woman's UniversityCompleted
-
Efforia, IncRecruiting
-
Efforia, IncRecruiting
Clinical Trials on Control - No training
-
Norwegian University of Science and TechnologyCompletedSubstance-related DisordersNorway
-
German Center for Neurodegenerative Diseases (DZNE)German Research FoundationCompletedHealthy | Cognitive Decline | Age-related Cognitive DeclineGermany
-
University of ArkansasCompleted
-
Raphael Mendes Ritti DiasRecruitingHypertension | Elderly (People Aged 65 or More)Brazil
-
Ahvaz Jundishapur University of Medical SciencesCompleted
-
University of Alabama at BirminghamNational Institute of Nursing Research (NINR)CompletedCognitive Impairment | Aging | Cognitive Decline | Attention Impaired | Cognitive Deficit in Attention | HIV-Associated Cognitive Motor Complex | Processing, Visual Spatial | Cognitive Disorder in RemissionUnited States
-
Beijing Sport UniversityCompletedPsychological Self-talk Interventions in Soccer PerformanceChina
-
Istanbul Gelisim UniversityCompletedNeuromuscular Fatigue | Load-velocity VariablesTurkey (Türkiye)
-
Gümüşhane UniversıtyCompletedFatty Liver | Aging | Inspiratory Muscle Weakness | Reduced Functional CapacityTurkey (Türkiye)
-
Universidade Federal do Rio de JaneiroCompleted