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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134781
Other study ID # DoIT-UTH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date April 2017

Study information

Verified date October 2021
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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) reduce body mass, ii) improve body composition and iii) alter energy balance, of previously inactive, overweight/obese women.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date April 2017
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
DoIT workout
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 - Detraining
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 training
No training was performed during a 40-week period. Participation only in measurements.

Locations

Country Name City State
Greece Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly Trikala Karies

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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 — View Citation

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 alt — View Citation

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 regulatio — View Citation

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 adapt — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body mass At baseline, at 20 weeks and at 40 weeks.
Primary Change in body mass index At baseline, at 20 weeks and at 40 weeks.
Primary Change in waist circumference At baseline, at 20 weeks and at 40 weeks.
Primary Change in hip circumference At baseline, at 20 weeks and at 40 weeks.
Primary Change in waist-to-hip ratio At baseline, at 20 weeks and at 40 weeks.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary Change in exercise-induced caloric expenditure. Measured using a portable indirect calorimetry system At baseline, at 20 weeks and at 40 weeks.
Secondary Change in maximal strength (1RM) Measured bilaterally on a horizontal leg press. At baseline, at 20 weeks and at 40 weeks.
Secondary Change in maximal oxygen consumption (VO2max) Assessed by a portable open-circuit spirometry system. At baseline, at 20 weeks and at 40 weeks.
Secondary Change in blood lactate concentration Pre-exercise, during the exercise and post-exercise at baseline, at 20 weeks and at 40 weeks.
Secondary Change in habitual physical activity Seven-day habitual physical activity was assessed by accelerometry At baseline, at 20 weeks and at 40 weeks.
Secondary Change in dietary intake Assessed using 7-day diet recalls At baseline, at 20 weeks and at 40 weeks.
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