High-Intensity Interval TrainingNCT03759951
Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)
A study testing DoIT-1, DoIT-2 and DoIT-3 in people with High-Intensity Interval Training and Body Composition, run by University of Thessaly at 1 site in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training, Body Composition, Performance
- What is being tested?
- DoIT-1, DoIT-2 and DoIT-3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2019to 30 Sep 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- inactivity (no exercise participation for ≥6 months before the study; VO2max <30 ml·kg-1·min-1)
- age of 30-55 years
- overweight/obese (BMI 25.0-39.9)
- body fat percentage for women > 32% and for men > 25%
- waist circumference for women > 80 cm and for men > 94 cm
- medical clearance for strenuous physical training
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- no smoking for ≥6 months before the study
- no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
- no weight loss greater >10% of body mass before (≤6 months) the study
- no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal, musculoskeletal or mental disorders
Who cannot join
- Participants will be excluded from the study if they:
- will not participate in ≥80% of total exercise sessions
- will adhere to a nutritional intervention during the study
- will modify the habitual physical activity levels during the study
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly
Trikala, 42100
About this study
Official title: The Dose-response Effect of High-intensity Interval Neuromuscular Training on Health, Performance and Quality of Life in Overweight/Obese Adults: The DoIT Trial
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.
Read the detailed description
This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:
- Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
- 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.
- At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
- 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.
- 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:
- Control group (no training)
- DoIT-1 (1 session/week)
- DoIT-2 (2 sessions/week)
- DoIT-3 (3 sessions/week)
- Conditions
- High-Intensity Interval Training, Body Composition, Performance, Habitual Physical Activity
- Being tested
- DoIT-1, DoIT-2, DoIT-3, Control
- Keywords
- functional training, circuit training, interval training, neuromuscular training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoIT-1Behavioural
Also called Hybrid Interval Training
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-2Behavioural
Also called Hybrid Interval Training
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-3Behavioural
Also called Hybrid Interval Training
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.
ControlBehavioural
No training will be performed during a 1-year period. Participation only in measurements.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | No intervention. Participated only in measurements at baseline, at 6 months and at 12 months. Receives: Behavioral: Control |
| DoIT-1 | Experimental | 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. Receives: Behavioral: DoIT-1 |
| DoIT-2 | Experimental | 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. Receives: Behavioral: DoIT-2 |
| DoIT-3 | Experimental | 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. Receives: Behavioral: DoIT-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass
Body mass (kg) will be measured using a beam scale
Measured: At baseline, at 6 months and at 12 months
Change in body mass index
Body mass index will be calculated using the Quetelet's equation
Measured: At baseline, at 6 months and at 12 months
Change in waist circumference
Waist circumference (cm) will be measured using a Gullick II tape
Measured: At baseline, at 6 months and at 12 months
Change in hip circumference
Hip circumference (cm) will be measured using a Gullick II tape
Measured: At baseline, at 6 months and at 12 months
Change in waist-to-hip ratio
Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement
Measured: At baseline, at 6 months and at 12 months
Change in body fat
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline and at 12 months
Change in fat mass
Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline and at 12 months
Change in fat-free mass
Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline and at 12 months
Change in resting metabolic rate (RMR)
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
Measured: At baseline, at 6 months and at 12 months
Change in maximal strength (1RM)
1RM (kg) for the lower body will be measured bilaterally on a horizontal leg press, seated leg extension and lying leg curl machines while 1RM (kg) for the upper body will be measured on a seated chest press and lat pull-down machines
Measured: At baseline, at 6 months and at 12 months
Change in maximal oxygen consumption (VO2max)
VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test
Measured: At baseline, at 6 months and at 12 months
Change in habitual physical activity (PA)
Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)
Measured: At baseline, at 3, 6, 9 and 12 months
Change in dietary intake
Dietary intake (kcal) will be assessed using 7-day diet recalls
Measured: At baseline, at 3, 6, 9 and 12 months
Change in body mass content (BMC)
BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
Measured: At baseline and at 12 months
Change in body mass density (BMD)
BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
Measured: At baseline and at 12 months
Change in resting systolic (SBP) and diastolic (DBP) blood pressures.
Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer
Measured: At baseline, at 6 months and at 12 months
Change in mean arterial pressure (MAP).
MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3
Measured: At baseline, at 6 months and at 12 months
Change in resting heart rate (RHR).
RHR (bpm) will be measured by pulse palpation for 60 seconds.
Measured: At baseline, at 6 months and at 12 months
Change in muscular endurance
Muscular endurance (repetitions until muscle failure) will be assessed using timed tests (60 sec) for the abdominal musculature, upper and lower body. The tests will include partial curl-up, push-up for males and modified push-up for females (kneeling position) and modified chair squat, respectively
Measured: At baseline, at 6 months and at 12 months
Change in flexibility
Flexibility (cm) will be assessed using the modified sit-and-reach test
Measured: At baseline, at 6 months and at 12 months
Change in static balance
Static balance (sec) will be assessed using the Sharpened Romberg test
Measured: At baseline, at 6 months and at 12 months
Change in functional capacity
Functional capacity will be assessed using a movement-based screening tool titled Functional Movement Screening (FMS). The FMS will be consisted of 7 movement tasks that will be scored from 0 to 3 points and the sum will create score ranging from 0 to 21 points (0 = pain with pattern regardless of quality, 1 = unable to perform pattern, 2 = able to perform pattern with compensation/imperfection, 3 = able to perform pattern as directed).
Measured: At baseline, at 6 months and at 12 months
Change in blood lipids
Total serum cholesterol (mmol/L), triglycerides (mmol/L), low-density lipoprotein (mmol/L) and high-density lipoprotein (mmol/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in blood inflammatory markers
Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in cortisol
Cortisol (nmol/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in insulin
Insulin (mIU/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in homeostatic model assessment for insulin resistance (HOMA-IR)
HOMA-IR will be measured with commercially availlable kits. ΗΟΜΑ score will be calculated using the equation HOMA-IR = fasting insulin (mIU/L) x fasting glucose (mg/dL) / 405. HOMA-IR score will be classified using the following range: normal insulin resistance < 3, moderate insulin resistance 3-5, severe insulin resistance > 5)
Measured: At baseline and at 12 months
Change in leptin
Leptin (μg/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in adiponectin
Adiponectin (μg/mL) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)
IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in fasting blood glucose (FBG)
FBG (mg/dL) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in serum protein carbonyl levels
Protein carbonyl (mg) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in thiobarbituric acid-reactive substances (TBARS)
TBARS (nmol/mg protein) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in reduced (GSH) and oxidized (GSSG) glutathione
GSH and GSSG (nmol/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in catalase activity
Catalase activity (units) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in total antioxidant capacity (TAC)
TAC (mmol/l) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in C-reactive protein (CRP)
CRP (mg/L) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in cholecystokinin (CKK)
CKK (ng/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in pancreatic polypeptide (PP)
PP (pg/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in peptide YY (PYY)
PYY (ng/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in oxyntomodulin (OXM)
OXM (pg/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in ghrelin
Ghrelin (pg/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in glucagon-like peptide-1 (GLP-1)
GLP-1 (pg/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in appetite
The Visual Analog Scale (VAS) will be used to measure perceived hunger, satiety, and individual's own interpretation of their hunger sensations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).
Measured: At baseline, at 6 months and at 12 months
Change in quality of life
Quality of life will be assessed using the physical and mental component subscales of the Greek 36-Item Short-Form Health Survey (SF-36). The scores on both component subscales of the SF-36 will range from 0 to 100, with higher scores indicating better health status while the minimal clinically important difference will be 2 points.
Measured: At baseline, at 6 months and at 12 months
Change in exercise enjoyment
Exercise enjoyment will be assessed using the Exercise Enjoyment Scale (EES), which is a single-item 7-point scale to assess enjoyment pre-, during, and post-exercise ranging from "not at all" at 1 to "extremely" at 7.
Measured: At baseline, at 6 months and at 12 months
Change in affective valence
Affective responses to exercise will be assessed using the Feeling Scale (FS), which is a single-item 11-point scale to assess feeling of pleasure pre-, during, and post-exercise training ranging from "very good" at -5 to "very bad" at 5.
Measured: At baseline, at 6 months and at 12 months
Change in irisin
Irisin (ng/ml) will be measured with commercially availlable kits
Measured: At baseline and at 12 months
Change in left ventricular end-diastolic volume (LVEDV).
LVEDV (ml) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular end-systolic volume (LVESV).
LVESV (ml) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular stroke volume (LVSV).
LVSV (ml) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in interventricular septum end diastole (IVSd).
IVSd (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in interventricular septum end diastole (IVSs).
IVSs (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular ejection fraction (LVEF).
LVEF (%) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular internal diameter end diastole (LVIDd).
LVIDd (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular internal diameter end systole (LVIDs).
LVIDs (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular posterior wall end diastole (LVPWd).
LVPWd (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular mass (LV mass).
LV mass (g) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left atrial (LA) diameter.
LA diameter (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in aortic root.
Aortic root (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in aortic valve velocity (AoV Vel).
AoV Vel (cm/s) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in aortic valve pressure gradient (AoV PG).
AoV PG (mmHg) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in right ventricular end diastole (RVD).
RVD (mm) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in pulmonary artery systolic pressure (PASP).
PASP (mmHg) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in left ventricular fractional shortening (FS).
Fractional shortening (%) will be measured using echocardiography.
Measured: At baseline and at 12 months
Change in depression II.
Depression will be measured using the Patient Health Questionnaire (PHQ-9)), which is a self-administered instrument consisiting of 9 multiple-choice questions scored from 0 to 3. Higher total scores indicate higher depression severity.
Measured: At baseline, at 6 months and at 12 months
Change in depression I.
Depression will be measured using the Beck Depression Inventory (BDI), which is a self-report questionnaire consisiting of 21 multiple-choice questions scored from 0 to 3. Higher total scores indicate more severe depressive symptoms.
Measured: At baseline, at 6 months and at 12 months
Change in depression and anxiety.
Both depression and anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater anxiety and depression.
Measured: At baseline, at 6 months and at 12 months
Change in mood.
Mood will be measured using the Profile of Mood States (POMS) questionnaire, which uses a unipolar scale to rate the extent to which they are experiencing or have experienced 20 affect states in the past week using a 5-point scale (0 = not at all, 4 = extremely). Higher scores indicate greater negative mood.
Measured: At baseline, at 6 months and at 12 months
Change in anxiety.
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which is an instrument that has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: At baseline, at 6 months and at 12 months
Change in physical self.
Physical self will be measured using the Physical Self-Perception Profile (PSPP), which is an instrument with 30 questions comprising five 6-item subscales. Each item has a four-point structured-alternative format. Scores range from 6 to 24 on each subscale, with high scores representing positive perceptions. Half of the items are worded in the negative direction.
Measured: At baseline, at 6 months and at 12 months
Secondary outcomes (7)
Change in exercise-induced caloric expenditure
Measured using a portable indirect calorimetry system
Measured: At baseline, at 6 months and at 12 months
Change in blood lactate concentration (BLa)
BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits. Blood samples will be collected pre-, mid- and post-exercise session (single bout) at 3 min post-exercise
Measured: At baseline, at 6 months and at 12 months
Change in peak expiratory flow (PEF)
PEF (l/s) will be measured using the maximum flow volume loop.
Measured: At baseline and at 12 months
Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).
FEF25-75 (l/s) will be measured using the maximum flow volume loop.
Measured: At baseline and at 12 months
Change in forced expiratory volume at 1 s (FEV1).
FEV1 (l) will be measured using the maximum flow volume loop.
Measured: At baseline and at 12 months
Change in forced vital capacity (FVC).
FVC (l) will be measured using the maximum flow volume loop.
Measured: At baseline and at 12 months
Change in the ratio of FEV1/FVC.
FEV1/FVC (%) will be measured using the maximum flow volume loop.
Measured: At baseline and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jul 2019
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High-Intensity Interval TrainingStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- 120 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
- Investigators
- Alexios Batrakoulis, MSc, Principal investigator, SmArT Lab, DPESS, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759951
- Sponsor's protocol ID
- DoIT II-UTH
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2018
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31193901Batrakoulis 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.
PubMed 34974824
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-response Effect of High-intensity Interval Neuromuscular Training on Health, Performance and Quality of Life in Overweight/Obese Adults: The DoIT Trial
- ClinicalTrials.gov ID
- NCT03759951
- Acronym / sponsor ID
- DoIT II-UTH
- Conditions
- High-Intensity Interval Training, Body Composition, Performance, Habitual Physical Activity
- Keywords
- functional training, circuit training, interval training, neuromuscular training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Nov 2018 (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.
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
This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:
- Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
- 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.
- At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
- 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.
- 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:
- Control group (no training)
- DoIT-1 (1 session/week)
- DoIT-2 (2 sessions/week)
- DoIT-3 (3 sessions/week)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlNo intervention. Participated only in measurements at baseline, at 6 months and at 12 months. |
| DoIT-1 | Experimental | Behavioral: DoIT-1Participated in a supervised 1-year workout exercise training program once per week and in measurements at baseline, at 6 months and at 12 months. |
| DoIT-2 | Experimental | Behavioral: DoIT-2Participated in a supervised 1-year workout exercise training program twice per week and in measurements at baseline, at 6 months and at 12 months. |
| DoIT-3 | Experimental | Behavioral: DoIT-3Participated in a supervised 1-year workout exercise training program thrice per week and in measurements at baseline, at 6 months and at 12 months. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- inactivity (no exercise participation for ≥6 months before the study; VO2max <30 ml·kg-1·min-1)
- age of 30-55 years
- overweight/obese (BMI 25.0-39.9)
- body fat percentage for women > 32% and for men > 25%
- waist circumference for women > 80 cm and for men > 94 cm
Key exclusion criteria (4 listed)
- will not participate in ≥80% of total exercise sessions
- will adhere to a nutritional intervention during the study
- will modify the habitual physical activity levels during the study
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-1Also: Hybrid Interval TrainingA 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. | Behavioural | DoIT-1 |
| DoIT-2Also: Hybrid Interval TrainingA 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. | Behavioural | DoIT-2 |
| DoIT-3Also: Hybrid Interval TrainingA 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. | Behavioural | DoIT-3 |
| ControlNo training will be performed during a 1-year period. Participation only in measurements. | Behavioural | Control |
Primary outcome
Change in body mass
Time frame: At baseline, at 6 months and at 12 months
Body mass (kg) will be measured using a beam scale
Change in body mass index
Time frame: At baseline, at 6 months and at 12 months
Body mass index will be calculated using the Quetelet's equation
Change in waist circumference
Time frame: At baseline, at 6 months and at 12 months
Waist circumference (cm) will be measured using a Gullick II tape
Change in hip circumference
Time frame: At baseline, at 6 months and at 12 months
Hip circumference (cm) will be measured using a Gullick II tape
Change in waist-to-hip ratio
Time frame: At baseline, at 6 months and at 12 months
Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement
Change in body fat
Time frame: At baseline and at 12 months
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Change in fat mass
Time frame: At baseline and at 12 months
Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Change in fat-free mass
Time frame: At baseline and at 12 months
Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Change in resting metabolic rate (RMR)
Time frame: At baseline, at 6 months and at 12 months
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
Change in maximal strength (1RM)
Time frame: At baseline, at 6 months and at 12 months
1RM (kg) for the lower body will be measured bilaterally on a horizontal leg press, seated leg extension and lying leg curl machines while 1RM (kg) for the upper body will be measured on a seated chest press and lat pull-down machines
Change in maximal oxygen consumption (VO2max)
Time frame: At baseline, at 6 months and at 12 months
VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test
Change in habitual physical activity (PA)
Time frame: At baseline, at 3, 6, 9 and 12 months
Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)
Change in dietary intake
Time frame: At baseline, at 3, 6, 9 and 12 months
Dietary intake (kcal) will be assessed using 7-day diet recalls
Change in body mass content (BMC)
Time frame: At baseline and at 12 months
BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
Change in body mass density (BMD)
Time frame: At baseline and at 12 months
BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
Change in resting systolic (SBP) and diastolic (DBP) blood pressures.
Time frame: At baseline, at 6 months and at 12 months
Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer
Change in mean arterial pressure (MAP).
Time frame: At baseline, at 6 months and at 12 months
MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3
Change in resting heart rate (RHR).
Time frame: At baseline, at 6 months and at 12 months
RHR (bpm) will be measured by pulse palpation for 60 seconds.
Change in muscular endurance
Time frame: At baseline, at 6 months and at 12 months
Muscular endurance (repetitions until muscle failure) will be assessed using timed tests (60 sec) for the abdominal musculature, upper and lower body. The tests will include partial curl-up, push-up for males and modified push-up for females (kneeling position) and modified chair squat, respectively
Change in flexibility
Time frame: At baseline, at 6 months and at 12 months
Flexibility (cm) will be assessed using the modified sit-and-reach test
Change in static balance
Time frame: At baseline, at 6 months and at 12 months
Static balance (sec) will be assessed using the Sharpened Romberg test
Change in functional capacity
Time frame: At baseline, at 6 months and at 12 months
Functional capacity will be assessed using a movement-based screening tool titled Functional Movement Screening (FMS). The FMS will be consisted of 7 movement tasks that will be scored from 0 to 3 points and the sum will create score ranging from 0 to 21 points (0 = pain with pattern regardless of quality, 1 = unable to perform pattern, 2 = able to perform pattern with compensation/imperfection, 3 = able to perform pattern as directed).
Change in blood lipids
Time frame: At baseline and at 12 months
Total serum cholesterol (mmol/L), triglycerides (mmol/L), low-density lipoprotein (mmol/L) and high-density lipoprotein (mmol/L) will be measured with commercially availlable kits
Change in blood inflammatory markers
Time frame: At baseline and at 12 months
Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits
Change in cortisol
Time frame: At baseline and at 12 months
Cortisol (nmol/L) will be measured with commercially availlable kits
Change in insulin
Time frame: At baseline and at 12 months
Insulin (mIU/L) will be measured with commercially availlable kits
Change in homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: At baseline and at 12 months
HOMA-IR will be measured with commercially availlable kits. ΗΟΜΑ score will be calculated using the equation HOMA-IR = fasting insulin (mIU/L) x fasting glucose (mg/dL) / 405. HOMA-IR score will be classified using the following range: normal insulin resistance < 3, moderate insulin resistance 3-5, severe insulin resistance > 5)
Change in leptin
Time frame: At baseline and at 12 months
Leptin (μg/L) will be measured with commercially availlable kits
Change in adiponectin
Time frame: At baseline and at 12 months
Adiponectin (μg/mL) will be measured with commercially availlable kits
Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)
Time frame: At baseline and at 12 months
IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits
Change in fasting blood glucose (FBG)
Time frame: At baseline and at 12 months
FBG (mg/dL) will be measured with commercially availlable kits
Change in serum protein carbonyl levels
Time frame: At baseline and at 12 months
Protein carbonyl (mg) will be measured with commercially availlable kits
Change in thiobarbituric acid-reactive substances (TBARS)
Time frame: At baseline and at 12 months
TBARS (nmol/mg protein) will be measured with commercially availlable kits
Change in reduced (GSH) and oxidized (GSSG) glutathione
Time frame: At baseline and at 12 months
GSH and GSSG (nmol/L) will be measured with commercially availlable kits
Change in catalase activity
Time frame: At baseline and at 12 months
Catalase activity (units) will be measured with commercially availlable kits
Change in total antioxidant capacity (TAC)
Time frame: At baseline and at 12 months
TAC (mmol/l) will be measured with commercially availlable kits
Change in C-reactive protein (CRP)
Time frame: At baseline and at 12 months
CRP (mg/L) will be measured with commercially availlable kits
Change in cholecystokinin (CKK)
Time frame: At baseline and at 12 months
CKK (ng/ml) will be measured with commercially availlable kits
Change in pancreatic polypeptide (PP)
Time frame: At baseline and at 12 months
PP (pg/ml) will be measured with commercially availlable kits
Change in peptide YY (PYY)
Time frame: At baseline and at 12 months
PYY (ng/ml) will be measured with commercially availlable kits
Change in oxyntomodulin (OXM)
Time frame: At baseline and at 12 months
OXM (pg/ml) will be measured with commercially availlable kits
Change in ghrelin
Time frame: At baseline and at 12 months
Ghrelin (pg/ml) will be measured with commercially availlable kits
Change in glucagon-like peptide-1 (GLP-1)
Time frame: At baseline and at 12 months
GLP-1 (pg/ml) will be measured with commercially availlable kits
Change in appetite
Time frame: At baseline, at 6 months and at 12 months
The Visual Analog Scale (VAS) will be used to measure perceived hunger, satiety, and individual's own interpretation of their hunger sensations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).
Change in quality of life
Time frame: At baseline, at 6 months and at 12 months
Quality of life will be assessed using the physical and mental component subscales of the Greek 36-Item Short-Form Health Survey (SF-36). The scores on both component subscales of the SF-36 will range from 0 to 100, with higher scores indicating better health status while the minimal clinically important difference will be 2 points.
Change in exercise enjoyment
Time frame: At baseline, at 6 months and at 12 months
Exercise enjoyment will be assessed using the Exercise Enjoyment Scale (EES), which is a single-item 7-point scale to assess enjoyment pre-, during, and post-exercise ranging from "not at all" at 1 to "extremely" at 7.
Change in affective valence
Time frame: At baseline, at 6 months and at 12 months
Affective responses to exercise will be assessed using the Feeling Scale (FS), which is a single-item 11-point scale to assess feeling of pleasure pre-, during, and post-exercise training ranging from "very good" at -5 to "very bad" at 5.
Change in irisin
Time frame: At baseline and at 12 months
Irisin (ng/ml) will be measured with commercially availlable kits
Change in left ventricular end-diastolic volume (LVEDV).
Time frame: At baseline and at 12 months
LVEDV (ml) will be measured using echocardiography.
Change in left ventricular end-systolic volume (LVESV).
Time frame: At baseline and at 12 months
LVESV (ml) will be measured using echocardiography.
Change in left ventricular stroke volume (LVSV).
Time frame: At baseline and at 12 months
LVSV (ml) will be measured using echocardiography.
Change in interventricular septum end diastole (IVSd).
Time frame: At baseline and at 12 months
IVSd (mm) will be measured using echocardiography.
Change in interventricular septum end diastole (IVSs).
Time frame: At baseline and at 12 months
IVSs (mm) will be measured using echocardiography.
Change in left ventricular ejection fraction (LVEF).
Time frame: At baseline and at 12 months
LVEF (%) will be measured using echocardiography.
Change in left ventricular internal diameter end diastole (LVIDd).
Time frame: At baseline and at 12 months
LVIDd (mm) will be measured using echocardiography.
Change in left ventricular internal diameter end systole (LVIDs).
Time frame: At baseline and at 12 months
LVIDs (mm) will be measured using echocardiography.
Change in left ventricular posterior wall end diastole (LVPWd).
Time frame: At baseline and at 12 months
LVPWd (mm) will be measured using echocardiography.
Change in left ventricular mass (LV mass).
Time frame: At baseline and at 12 months
LV mass (g) will be measured using echocardiography.
Change in left atrial (LA) diameter.
Time frame: At baseline and at 12 months
LA diameter (mm) will be measured using echocardiography.
Change in aortic root.
Time frame: At baseline and at 12 months
Aortic root (mm) will be measured using echocardiography.
Change in aortic valve velocity (AoV Vel).
Time frame: At baseline and at 12 months
AoV Vel (cm/s) will be measured using echocardiography.
Change in aortic valve pressure gradient (AoV PG).
Time frame: At baseline and at 12 months
AoV PG (mmHg) will be measured using echocardiography.
Change in right ventricular end diastole (RVD).
Time frame: At baseline and at 12 months
RVD (mm) will be measured using echocardiography.
Change in pulmonary artery systolic pressure (PASP).
Time frame: At baseline and at 12 months
PASP (mmHg) will be measured using echocardiography.
Change in left ventricular fractional shortening (FS).
Time frame: At baseline and at 12 months
Fractional shortening (%) will be measured using echocardiography.
Change in depression II.
Time frame: At baseline, at 6 months and at 12 months
Depression will be measured using the Patient Health Questionnaire (PHQ-9)), which is a self-administered instrument consisiting of 9 multiple-choice questions scored from 0 to 3. Higher total scores indicate higher depression severity.
Change in depression I.
Time frame: At baseline, at 6 months and at 12 months
Depression will be measured using the Beck Depression Inventory (BDI), which is a self-report questionnaire consisiting of 21 multiple-choice questions scored from 0 to 3. Higher total scores indicate more severe depressive symptoms.
Change in depression and anxiety.
Time frame: At baseline, at 6 months and at 12 months
Both depression and anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater anxiety and depression.
Change in mood.
Time frame: At baseline, at 6 months and at 12 months
Mood will be measured using the Profile of Mood States (POMS) questionnaire, which uses a unipolar scale to rate the extent to which they are experiencing or have experienced 20 affect states in the past week using a 5-point scale (0 = not at all, 4 = extremely). Higher scores indicate greater negative mood.
Change in anxiety.
Time frame: At baseline, at 6 months and at 12 months
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which is an instrument that has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Change in physical self.
Time frame: At baseline, at 6 months and at 12 months
Physical self will be measured using the Physical Self-Perception Profile (PSPP), which is an instrument with 30 questions comprising five 6-item subscales. Each item has a four-point structured-alternative format. Scores range from 6 to 24 on each subscale, with high scores representing positive perceptions. Half of the items are worded in the negative direction.
7 secondary outcomes
Change in exercise-induced caloric expenditure
Time frame: At baseline, at 6 months and at 12 months
Change in blood lactate concentration (BLa)
Time frame: At baseline, at 6 months and at 12 months
Change in peak expiratory flow (PEF)
Time frame: At baseline and at 12 months
Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).
Time frame: At baseline and at 12 months
Change in forced expiratory volume at 1 s (FEV1).
Time frame: At baseline and at 12 months
Change in forced vital capacity (FVC).
Time frame: At baseline and at 12 months
Change in the ratio of FEV1/FVC.
Time frame: At baseline and at 12 months
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 20 Jan 2022.
- Background: PubMed 31193901Batrakoulis 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.
- Results publication: PubMed 34974824Batrakoulis 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.
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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.
Alexios Batrakoulis, MSc principal investigator
SmArT Lab, DPESS, University of Thessaly
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-1, DoIT-2 and DoIT-3 in people with 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 10 inclusion and 4 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 20 Jan 2022. 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 6 months and at 12 months). The study lists 71 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 NCT03759951, which also lists 2 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 20 Jan 2022.