Circuit-based High Intensity Interval TrainingDoITNCT03134781
Hybrid Exercise Training for Weight Loss
A study testing DoIT workout and DoIT workout - Detraining in people with Circuit-based High Intensity Interval Training and Body Composition, run by University of Thessaly at 1 site in Greece.
Trial 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)… Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Circuit-based High Intensity Interval Training, Body Composition, Resting Metabolic Rate
- What is being tested?
- DoIT workout and DoIT workout - Detraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2015to Apr 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, Karies, 42100
About this study
Official title: 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.
Read the 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.
- Conditions
- Circuit-based High Intensity Interval Training, Body Composition, Resting Metabolic Rate, Habitual Physical Activity, Performance
- Being tested
- DoIT workout, DoIT workout - Detraining, Control - No training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoIT workoutBehavioural
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.
DoIT workout - DetrainingBehavioural
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.
Control - No trainingBehavioural
No training was performed during a 40-week period. Participation only in measurements.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Participated only in measurements at baseline, at 20 weeks and at 40 weeks. Receives: 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. Receives: 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. Receives: Behavioral: DoIT workout - Detraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in body mass index
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in waist circumference
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in hip circumference
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in waist-to-hip ratio
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in exercise-induced caloric expenditure.
Measured using a portable indirect calorimetry system
Measured: At baseline, at 20 weeks and at 40 weeks.
Secondary outcomes (5)
Change in maximal strength (1RM)
Measured bilaterally on a horizontal leg press.
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in maximal oxygen consumption (VO2max)
Assessed by a portable open-circuit spirometry system.
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in blood lactate concentration
Measured: Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
Change in habitual physical activity
Seven-day habitual physical activity was assessed by accelerometry
Measured: At baseline, at 20 weeks and at 40 weeks.
Change in dietary intake
Assessed using 7-day diet recalls
Measured: At baseline, at 20 weeks and at 40 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startJul 2015
- Primary completionJul 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Circuit-based High Intensity Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134781
- Sponsor's protocol ID
- DoIT-UTH
- Acronym
- DoIT
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2017
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30138475Batrakoulis 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.
PubMed 31478436Batrakoulis 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.
PubMed 33054601Batrakoulis 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.
PubMed 346797382020 NSCA Research Abstracts. J Strength Cond Res. 2021 Apr 1;35(4):e3-e288. doi: 10.1519/JSC.0000000000003877. No abstract available.
PubMed 33752224
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Novel Hybrid Exercise Training Program on Body Composition, Body Weight and Energy Balance in Sedentary Overweight/Obese Women
- ClinicalTrials.gov ID
- NCT03134781
- Acronym / sponsor ID
- DoIT / DoIT-UTH
- Conditions
- Circuit-based High Intensity Interval Training, Body Composition, Resting Metabolic Rate, Habitual Physical Activity, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Control - No trainingParticipated only in measurements at baseline, at 20 weeks and at 40 weeks. |
| Training | Experimental | Behavioral: DoIT workoutParticipated in a supervised 40-week DoIT workout exercise training program and in measurements at baseline, at 20 weeks and at 40 weeks. |
| Training-Detraining | Experimental | Behavioral: DoIT workout - DetrainingParticipated 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoIT workoutA 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. | Behavioural | Training |
| DoIT workout - DetrainingA 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. | Behavioural | Training-Detraining |
| Control - No trainingNo training was performed during a 40-week period. Participation only in measurements. | Behavioural | Control |
Primary outcome
Change in body mass
Time frame: 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.
Change in waist circumference
Time frame: At baseline, at 20 weeks and at 40 weeks.
Change in hip circumference
Time frame: 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.
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).
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).
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).
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.
Change in exercise-induced caloric expenditure.
Time frame: At baseline, at 20 weeks and at 40 weeks.
Measured using a portable indirect calorimetry system
5 secondary outcomes
Change in maximal strength (1RM)
Time frame: 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.
Change in blood lactate concentration
Time frame: 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.
Change in dietary intake
Time frame: At baseline, at 20 weeks and at 40 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Results publication: PubMed 30138475Batrakoulis 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.
- Results publication: PubMed 31478436Batrakoulis 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.
- Results publication: PubMed 33054601Batrakoulis 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.
- Results publication: PubMed 34679738Batrakoulis 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.
- Derived from this study: PubMed 337522242020 NSCA Research Abstracts. J Strength Cond Res. 2021 Apr 1;35(4):e3-e288. doi: 10.1519/JSC.0000000000003877. No abstract available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DoIT workout and DoIT workout - Detraining in people with Circuit-based High Intensity Interval Training and Body Composition, 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 1 inclusion and 1 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 28 Oct 2021. 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?
Change in body mass (time frame: At baseline, at 20 weeks and at 40 weeks.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134781, which also lists 5 linked publications.
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 28 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.