Body Composition, Habitual Physical Activity, High-Intensity Interval Training, Performance
Conditions
Keywords
functional training, circuit training, interval training, neuromuscular training
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)
Interventions
BEHAVIORALDoIT-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.
BEHAVIORALDoIT-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.
BEHAVIORALDoIT-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.
BEHAVIORALControl
No training will be performed during a 1-year period. Participation only in measurements.
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical self. | 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. |
| Change in pulmonary artery systolic pressure (PASP). | At baseline and at 12 months | PASP (mmHg) will be measured using echocardiography. |
| Change in left ventricular fractional shortening (FS). | At baseline and at 12 months | Fractional shortening (%) will be measured using echocardiography. |
| Change in depression II. | 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. | 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. | 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. | 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. | 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 body mass | At baseline, at 6 months and at 12 months | Body mass (kg) will be measured using a beam scale |
| Change in body mass index | At baseline, at 6 months and at 12 months | Body mass index will be calculated using the Quetelet's equation |
| Change in waist circumference | At baseline, at 6 months and at 12 months | Waist circumference (cm) will be measured using a Gullick II tape |
| Change in hip circumference | 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 | 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 | At baseline and at 12 months | Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA) |
| Change in fat mass | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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. | 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). | 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). | At baseline, at 6 months and at 12 months | RHR (bpm) will be measured by pulse palpation for 60 seconds. |
| Change in muscular endurance | 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 | 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 | At baseline, at 6 months and at 12 months | Static balance (sec) will be assessed using the Sharpened Romberg test |
| Change in functional capacity | 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 | 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 | At baseline and at 12 months | Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits |
| Change in cortisol | At baseline and at 12 months | Cortisol (nmol/L) will be measured with commercially availlable kits |
| Change in insulin | At baseline and at 12 months | Insulin (mIU/L) will be measured with commercially availlable kits |
| Change in aortic valve velocity (AoV Vel). | At baseline and at 12 months | AoV Vel (cm/s) will be measured using echocardiography. |
| Change in homeostatic model assessment for insulin resistance (HOMA-IR) | 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 | At baseline and at 12 months | Leptin (μg/L) will be measured with commercially availlable kits |
| Change in adiponectin | 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) | 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) | At baseline and at 12 months | FBG (mg/dL) will be measured with commercially availlable kits |
| Change in serum protein carbonyl levels | At baseline and at 12 months | Protein carbonyl (mg) will be measured with commercially availlable kits |
| Change in thiobarbituric acid-reactive substances (TBARS) | 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 | At baseline and at 12 months | GSH and GSSG (nmol/L) will be measured with commercially availlable kits |
| Change in catalase activity | At baseline and at 12 months | Catalase activity (units) will be measured with commercially availlable kits |
| Change in total antioxidant capacity (TAC) | At baseline and at 12 months | TAC (mmol/l) will be measured with commercially availlable kits |
| Change in C-reactive protein (CRP) | At baseline and at 12 months | CRP (mg/L) will be measured with commercially availlable kits |
| Change in cholecystokinin (CKK) | At baseline and at 12 months | CKK (ng/ml) will be measured with commercially availlable kits |
| Change in pancreatic polypeptide (PP) | At baseline and at 12 months | PP (pg/ml) will be measured with commercially availlable kits |
| Change in peptide YY (PYY) | At baseline and at 12 months | PYY (ng/ml) will be measured with commercially availlable kits |
| Change in oxyntomodulin (OXM) | At baseline and at 12 months | OXM (pg/ml) will be measured with commercially availlable kits |
| Change in ghrelin | At baseline and at 12 months | Ghrelin (pg/ml) will be measured with commercially availlable kits |
| Change in glucagon-like peptide-1 (GLP-1) | At baseline and at 12 months | GLP-1 (pg/ml) will be measured with commercially availlable kits |
| Change in appetite | 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 | 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 | 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 | 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 | At baseline and at 12 months | Irisin (ng/ml) will be measured with commercially availlable kits |
| Change in left ventricular end-diastolic volume (LVEDV). | At baseline and at 12 months | LVEDV (ml) will be measured using echocardiography. |
| Change in left ventricular end-systolic volume (LVESV). | At baseline and at 12 months | LVESV (ml) will be measured using echocardiography. |
| Change in left ventricular stroke volume (LVSV). | At baseline and at 12 months | LVSV (ml) will be measured using echocardiography. |
| Change in interventricular septum end diastole (IVSd). | At baseline and at 12 months | IVSd (mm) will be measured using echocardiography. |
| Change in interventricular septum end diastole (IVSs). | At baseline and at 12 months | IVSs (mm) will be measured using echocardiography. |
| Change in left ventricular ejection fraction (LVEF). | At baseline and at 12 months | LVEF (%) will be measured using echocardiography. |
| Change in left ventricular internal diameter end diastole (LVIDd). | At baseline and at 12 months | LVIDd (mm) will be measured using echocardiography. |
| Change in left ventricular internal diameter end systole (LVIDs). | At baseline and at 12 months | LVIDs (mm) will be measured using echocardiography. |
| Change in left ventricular posterior wall end diastole (LVPWd). | At baseline and at 12 months | LVPWd (mm) will be measured using echocardiography. |
| Change in left ventricular mass (LV mass). | At baseline and at 12 months | LV mass (g) will be measured using echocardiography. |
| Change in left atrial (LA) diameter. | At baseline and at 12 months | LA diameter (mm) will be measured using echocardiography. |
| Change in aortic root. | At baseline and at 12 months | Aortic root (mm) will be measured using echocardiography. |
| Change in aortic valve pressure gradient (AoV PG). | At baseline and at 12 months | AoV PG (mmHg) will be measured using echocardiography. |
| Change in right ventricular end diastole (RVD). | At baseline and at 12 months | RVD (mm) will be measured using echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood lactate concentration (BLa) | At baseline, at 6 months and at 12 months | 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 |
| Change in peak expiratory flow (PEF) | At baseline and at 12 months | PEF (l/s) will be measured using the maximum flow volume loop. |
| Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75). | At baseline and at 12 months | FEF25-75 (l/s) will be measured using the maximum flow volume loop. |
| Change in forced expiratory volume at 1 s (FEV1). | At baseline and at 12 months | FEV1 (l) will be measured using the maximum flow volume loop. |
| Change in forced vital capacity (FVC). | At baseline and at 12 months | FVC (l) will be measured using the maximum flow volume loop. |
| Change in the ratio of FEV1/FVC. | At baseline and at 12 months | FEV1/FVC (%) will be measured using the maximum flow volume loop. |
| Change in exercise-induced caloric expenditure | At baseline, at 6 months and at 12 months | Measured using a portable indirect calorimetry system |
Countries
Greece
Outcome results
None listed