Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)

NCT ID: NCT03759951

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-09-30

Brief Summary

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Observing a lack of research investigating the chronic physiological and psychological responses to this type of exercise training the aim of this study is to investigate the optimal training configurations of DoIT to produce positive effects on health, performance and quality of life markers in sedentary overweight or obese adults aged 30-55 years. The DoIT program will be performed in a small-group setting indoor or outdoor implementing a progressive manner for 12 months and using bodyweight exercises with alternative modes.

Detailed Description

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This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:

1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
2. a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
3. At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
4. After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
5. After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.

All participants will be randomly assigned to the following four groups:

1. Control group (no training)
2. DoIT-1 (1 session/week)
3. DoIT-2 (2 sessions/week)
4. DoIT-3 (3 sessions/week)

Conditions

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High-Intensity Interval Training Body Composition Performance Habitual Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

No intervention. Participated only in measurements at baseline, at 6 months and at 12 months.

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

No training will be performed during a 1-year period. Participation only in measurements.

DoIT-1

Participated in a supervised 1-year workout exercise training program once per week and in measurements at baseline, at 6 months and at 12 months.

Group Type EXPERIMENTAL

DoIT-1

Intervention Type BEHAVIORAL

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed once per week on non-consecutive days for 12 months.

DoIT-2

Participated in a supervised 1-year workout exercise training program twice per week and in measurements at baseline, at 6 months and at 12 months.

Group Type EXPERIMENTAL

DoIT-2

Intervention Type BEHAVIORAL

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed twice per week on non-consecutive days for 12 months.

DoIT-3

Participated in a supervised 1-year workout exercise training program thrice per week and in measurements at baseline, at 6 months and at 12 months.

Group Type EXPERIMENTAL

DoIT-3

Intervention Type BEHAVIORAL

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed thrice per week on non-consecutive days for 12 months.

Interventions

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DoIT-1

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed once per week on non-consecutive days for 12 months.

Intervention Type BEHAVIORAL

DoIT-2

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed twice per week on non-consecutive days for 12 months.

Intervention Type BEHAVIORAL

DoIT-3

A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed thrice per week on non-consecutive days for 12 months.

Intervention Type BEHAVIORAL

Control

No training will be performed during a 1-year period. Participation only in measurements.

Intervention Type BEHAVIORAL

Other Intervention Names

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Hybrid Interval Training Hybrid Interval Training Hybrid Interval Training

Eligibility Criteria

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Inclusion Criteria

1. inactivity (no exercise participation for ≥6 months before the study; VO2max \<30 ml·kg-1·min-1)
2. age of 30-55 years
3. overweight/obese (BMI 25.0-39.9)
4. body fat percentage for women \> 32% and for men \> 25%
5. waist circumference for women \> 80 cm and for men \> 94 cm
6. medical clearance for strenuous physical training
7. no smoking for ≥6 months before the study
8. no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
9. no weight loss greater \>10% of body mass before (≤6 months) the study
10. no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal, musculoskeletal or mental disorders

Exclusion Criteria

Participants will be excluded from the study if they:

1. will not participate in ≥80% of total exercise sessions
2. will adhere to a nutritional intervention during the study
3. will modify the habitual physical activity levels during the study
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Ioannis G. Fatouros

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexios Batrakoulis, MSc

Role: PRINCIPAL_INVESTIGATOR

SmArT Lab, DPESS, University of Thessaly

Locations

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Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly

Trikala, , Greece

Site Status

Countries

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Greece

References

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Batrakoulis A, Fatouros IG, Chatzinikolaou A, Draganidis D, Georgakouli K, Papanikolaou K, Deli CK, Tsimeas P, Avloniti A, Syrou N, Jamurtas AZ. Dose-response effects of high-intensity interval neuromuscular exercise training on weight loss, performance, health and quality of life in inactive obese adults: Study rationale, design and methods of the DoIT trial. Contemp Clin Trials Commun. 2019 May 23;15:100386. doi: 10.1016/j.conctc.2019.100386. eCollection 2019 Sep.

Reference Type BACKGROUND
PMID: 31193901 (View on PubMed)

Batrakoulis A, Jamurtas AZ, Tsimeas P, Poulios A, Perivoliotis K, Syrou N, Papanikolaou K, Draganidis D, Deli CK, Metsios GS, Angelopoulos TJ, Feito Y, Fatouros IG. Hybrid-type, multicomponent interval training upregulates musculoskeletal fitness of adults with overweight and obesity in a volume-dependent manner: A 1-year dose-response randomised controlled trial. Eur J Sport Sci. 2023 Mar;23(3):432-443. doi: 10.1080/17461391.2021.2025434. Epub 2022 Jan 31.

Reference Type RESULT
PMID: 34974824 (View on PubMed)

Other Identifiers

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DoIT II-UTH

Identifier Type: -

Identifier Source: org_study_id

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