Clinical trial NCT03759951: Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-Intensity Interval Training
Body Composition
Performance
Habitual Physical Activity
Keywords: functional training
circuit training
interval training
neuromuscular training
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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:

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in body mass index
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in waist circumference
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in hip circumference
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in waist-to-hip ratio
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in body fat
timeFrame: At baseline and at 12 months
measure: Change in fat mass
timeFrame: At baseline and at 12 months
measure: Change in fat-free mass
timeFrame: At baseline and at 12 months
measure: Change in resting metabolic rate (RMR)
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in maximal strength (1RM)
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in maximal oxygen consumption (VO2max)
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in habitual physical activity (PA)
timeFrame: At baseline, at 3, 6, 9 and 12 months
measure: Change in dietary intake
timeFrame: At baseline, at 3, 6, 9 and 12 months
measure: Change in body mass content (BMC)
timeFrame: At baseline and at 12 months
measure: Change in body mass density (BMD)
timeFrame: At baseline and at 12 months
measure: Change in resting systolic (SBP) and diastolic (DBP) blood pressures.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in mean arterial pressure (MAP).
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in resting heart rate (RHR).
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in muscular endurance
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in flexibility
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in static balance
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in functional capacity
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in blood lipids
timeFrame: At baseline and at 12 months
measure: Change in blood inflammatory markers
timeFrame: At baseline and at 12 months
measure: Change in cortisol
timeFrame: At baseline and at 12 months
measure: Change in insulin
timeFrame: At baseline and at 12 months
measure: Change in homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: At baseline and at 12 months
measure: Change in leptin
timeFrame: At baseline and at 12 months
measure: Change in adiponectin
timeFrame: At baseline and at 12 months
measure: Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)
timeFrame: At baseline and at 12 months
measure: Change in fasting blood glucose (FBG)
timeFrame: At baseline and at 12 months
measure: Change in serum protein carbonyl levels
timeFrame: At baseline and at 12 months
measure: Change in thiobarbituric acid-reactive substances (TBARS)
timeFrame: At baseline and at 12 months
measure: Change in reduced (GSH) and oxidized (GSSG) glutathione
timeFrame: At baseline and at 12 months
measure: Change in catalase activity
timeFrame: At baseline and at 12 months
measure: Change in total antioxidant capacity (TAC)
timeFrame: At baseline and at 12 months
measure: Change in C-reactive protein (CRP)
timeFrame: At baseline and at 12 months
measure: Change in cholecystokinin (CKK)
timeFrame: At baseline and at 12 months
measure: Change in pancreatic polypeptide (PP)
timeFrame: At baseline and at 12 months
measure: Change in peptide YY (PYY)
timeFrame: At baseline and at 12 months
measure: Change in oxyntomodulin (OXM)
timeFrame: At baseline and at 12 months
measure: Change in ghrelin
timeFrame: At baseline and at 12 months
measure: Change in glucagon-like peptide-1 (GLP-1)
timeFrame: At baseline and at 12 months
measure: Change in appetite
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in quality of life
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in exercise enjoyment
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in affective valence
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in irisin
timeFrame: At baseline and at 12 months
measure: Change in left ventricular end-diastolic volume (LVEDV).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular end-systolic volume (LVESV).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular stroke volume (LVSV).
timeFrame: At baseline and at 12 months
measure: Change in interventricular septum end diastole (IVSd).
timeFrame: At baseline and at 12 months
measure: Change in interventricular septum end diastole (IVSs).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular ejection fraction (LVEF).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular internal diameter end diastole (LVIDd).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular internal diameter end systole (LVIDs).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular posterior wall end diastole (LVPWd).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular mass (LV mass).
timeFrame: At baseline and at 12 months
measure: Change in left atrial (LA) diameter.
timeFrame: At baseline and at 12 months
measure: Change in aortic root.
timeFrame: At baseline and at 12 months
measure: Change in aortic valve velocity (AoV Vel).
timeFrame: At baseline and at 12 months
measure: Change in aortic valve pressure gradient (AoV PG).
timeFrame: At baseline and at 12 months
measure: Change in right ventricular end diastole (RVD).
timeFrame: At baseline and at 12 months
measure: Change in pulmonary artery systolic pressure (PASP).
timeFrame: At baseline and at 12 months
measure: Change in left ventricular fractional shortening (FS).
timeFrame: At baseline and at 12 months
measure: Change in depression II.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in depression I.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in depression and anxiety.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in mood.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in anxiety.
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in physical self.
timeFrame: At baseline, at 6 months and at 12 months
Secondary outcomes:
measure: Change in exercise-induced caloric expenditure
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in blood lactate concentration (BLa)
timeFrame: At baseline, at 6 months and at 12 months
measure: Change in peak expiratory flow (PEF)
timeFrame: At baseline and at 12 months
measure: Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).
timeFrame: At baseline and at 12 months
measure: Change in forced expiratory volume at 1 s (FEV1).
timeFrame: At baseline and at 12 months
measure: Change in forced vital capacity (FVC).
timeFrame: At baseline and at 12 months
measure: Change in the ratio of FEV1/FVC.
timeFrame: At baseline and at 12 months
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly
Study officials:
affiliation: SmArT Lab, DPESS, University of Thessaly
name: Alexios Batrakoulis, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.