<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759951</url>
  </required_header>
  <id_info>
    <org_study_id>DoIT II-UTH</org_study_id>
    <nct_id>NCT03759951</nct_id>
  </id_info>
  <brief_title>Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observing a lack of research investigating the chronic physiological and psychological&#xD;
      responses to this type of exercise training the aim of this study is to investigate the&#xD;
      optimal training configurations of DoIT to produce positive effects on health, performance&#xD;
      and quality of life markers in sedentary overweight or obese adults aged 30-55 years. The&#xD;
      DoIT program will be performed in a small-group setting indoor or outdoor implementing a&#xD;
      progressive manner for 12 months and using bodyweight exercises with alternative modes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This controlled, randomized, four-group, repeated-measures clinical trial will be consisted&#xD;
      of the following stages:&#xD;
&#xD;
        1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily&#xD;
           nutritional intake.&#xD;
&#xD;
        2. a 4-week adaptive period: based on a dietary analysis, participants will be given a&#xD;
           dietary plan (considering the RMR and total daily physical activity related energy&#xD;
           expenditure), providing an isocaloric diet over the initial 4-week adaptive period.&#xD;
           During this adaptive period, volunteers will also be familiarized with exercises&#xD;
           techniques and overload patterns that will be used throughout the study through 4&#xD;
           preparatory sessions.&#xD;
&#xD;
        3. At the end of the adaptation period, participants will participate in assessment&#xD;
           procedures (baseline testing) at University facilities.&#xD;
&#xD;
        4. After the adaptive period all participants will be randomly assigned to four groups&#xD;
           (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that&#xD;
           will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor&#xD;
           exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive&#xD;
           recovery intervals.&#xD;
&#xD;
        5. After 12 months of exercise intervention all participants will participate in assessment&#xD;
           procedures (post-training testing) at University facilities within 5 days after the&#xD;
           completion of the last training session.&#xD;
&#xD;
      All participants will be randomly assigned to the following four groups:&#xD;
&#xD;
        1. Control group (no training)&#xD;
&#xD;
        2. DoIT-1 (1 session/week)&#xD;
&#xD;
        3. DoIT-2 (2 sessions/week)&#xD;
&#xD;
        4. DoIT-3 (3 sessions/week)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Body mass (kg) will be measured using a beam scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Body mass index will be calculated using the Quetelet's equation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Waist circumference (cm) will be measured using a Gullick II tape</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in hip circumference</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Hip circumference (cm) will be measured using a Gullick II tape</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist-to-hip ratio</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body fat</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fat-free mass</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting metabolic rate (RMR)</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximal strength (1RM)</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximal oxygen consumption (VO2max)</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in habitual physical activity (PA)</measure>
    <time_frame>At baseline, at 3, 6, 9 and 12 months</time_frame>
    <description>Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dietary intake</measure>
    <time_frame>At baseline, at 3, 6, 9 and 12 months</time_frame>
    <description>Dietary intake (kcal) will be assessed using 7-day diet recalls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body mass content (BMC)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body mass density (BMD)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting systolic (SBP) and diastolic (DBP) blood pressures.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean arterial pressure (MAP).</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting heart rate (RHR).</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>RHR (bpm) will be measured by pulse palpation for 60 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in muscular endurance</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in flexibility</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Flexibility (cm) will be assessed using the modified sit-and-reach test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in static balance</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Static balance (sec) will be assessed using the Sharpened Romberg test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood lipids</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood inflammatory markers</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cortisol</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Cortisol (nmol/L) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Insulin (mIU/L) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in homeostatic model assessment for insulin resistance (HOMA-IR)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>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 &lt; 3, moderate insulin resistance 3-5, severe insulin resistance &gt; 5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in leptin</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Leptin (μg/L) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in adiponectin</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Adiponectin (μg/mL) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting blood glucose (FBG)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>FBG (mg/dL) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum protein carbonyl levels</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Protein carbonyl (mg) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in thiobarbituric acid-reactive substances (TBARS)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>TBARS (nmol/mg protein) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in reduced (GSH) and oxidized (GSSG) glutathione</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>GSH and GSSG (nmol/L) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in catalase activity</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Catalase activity (units) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total antioxidant capacity (TAC)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>TAC (mmol/l) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in C-reactive protein (CRP)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>CRP (mg/L) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cholecystokinin (CKK)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>CKK (ng/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pancreatic polypeptide (PP)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>PP (pg/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in peptide YY (PYY)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>PYY (ng/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxyntomodulin (OXM)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>OXM (pg/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ghrelin</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Ghrelin (pg/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in glucagon-like peptide-1 (GLP-1)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>GLP-1 (pg/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in appetite</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in exercise enjoyment</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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 &quot;not at all&quot; at 1 to &quot;extremely&quot; at 7.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in affective valence</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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 &quot;very good&quot; at -5 to &quot;very bad&quot; at 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in irisin</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Irisin (ng/ml) will be measured with commercially availlable kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular end-diastolic volume (LVEDV).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVEDV (ml) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular end-systolic volume (LVESV).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVESV (ml) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular stroke volume (LVSV).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVSV (ml) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interventricular septum end diastole (IVSd).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>IVSd (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interventricular septum end diastole (IVSs).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>IVSs (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular ejection fraction (LVEF).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVEF (%) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular internal diameter end diastole (LVIDd).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVIDd (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular internal diameter end systole (LVIDs).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVIDs (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular posterior wall end diastole (LVPWd).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LVPWd (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular mass (LV mass).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LV mass (g) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left atrial (LA) diameter.</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>LA diameter (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aortic root.</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Aortic root (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aortic valve velocity (AoV Vel).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>AoV Vel (cm/s) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aortic valve pressure gradient (AoV PG).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>AoV PG (mmHg) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in right ventricular end diastole (RVD).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>RVD (mm) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pulmonary artery systolic pressure (PASP).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>PASP (mmHg) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular fractional shortening (FS).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>Fractional shortening (%) will be measured using echocardiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression II.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression I.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression and anxiety.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mood.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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 &quot;Almost Never&quot; to &quot;Almost Always&quot;). Higher scores indicate greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physical self.</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in exercise-induced caloric expenditure</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>Measured using a portable indirect calorimetry system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood lactate concentration (BLa)</measure>
    <time_frame>At baseline, at 6 months and at 12 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak expiratory flow (PEF)</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>PEF (l/s) will be measured using the maximum flow volume loop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>FEF25-75 (l/s) will be measured using the maximum flow volume loop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expiratory volume at 1 s (FEV1).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>FEV1 (l) will be measured using the maximum flow volume loop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced vital capacity (FVC).</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>FVC (l) will be measured using the maximum flow volume loop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the ratio of FEV1/FVC.</measure>
    <time_frame>At baseline and at 12 months</time_frame>
    <description>FEV1/FVC (%) will be measured using the maximum flow volume loop.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>High-Intensity Interval Training</condition>
  <condition>Body Composition</condition>
  <condition>Performance</condition>
  <condition>Habitual Physical Activity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No intervention. Participated only in measurements at baseline, at 6 months and at 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DoIT-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DoIT-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DoIT-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DoIT-1</intervention_name>
    <description>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.</description>
    <arm_group_label>DoIT-1</arm_group_label>
    <other_name>Hybrid Interval Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DoIT-2</intervention_name>
    <description>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.</description>
    <arm_group_label>DoIT-2</arm_group_label>
    <other_name>Hybrid Interval Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DoIT-3</intervention_name>
    <description>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.</description>
    <arm_group_label>DoIT-3</arm_group_label>
    <other_name>Hybrid Interval Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>No training will be performed during a 1-year period. Participation only in measurements.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. inactivity (no exercise participation for ≥6 months before the study; VO2max &lt;30&#xD;
             ml·kg-1·min-1)&#xD;
&#xD;
          2. age of 30-55 years&#xD;
&#xD;
          3. overweight/obese (BMI 25.0-39.9)&#xD;
&#xD;
          4. body fat percentage for women &gt; 32% and for men &gt; 25%&#xD;
&#xD;
          5. waist circumference for women &gt; 80 cm and for men &gt; 94 cm&#xD;
&#xD;
          6. medical clearance for strenuous physical training&#xD;
&#xD;
          7. no smoking for ≥6 months before the study&#xD;
&#xD;
          8. no diet intervention or usage of nutritional supplements/medications before (≥6&#xD;
             months) and during the study&#xD;
&#xD;
          9. no weight loss greater &gt;10% of body mass before (≤6 months) the study&#xD;
&#xD;
         10. no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal,&#xD;
             musculoskeletal or mental disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded from the study if they:&#xD;
&#xD;
          1. will not participate in ≥80% of total exercise sessions&#xD;
&#xD;
          2. will adhere to a nutritional intervention during the study&#xD;
&#xD;
          3. will modify the habitual physical activity levels during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexios Batrakoulis, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>SmArT Lab, DPESS, University of Thessaly</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly</name>
      <address>
        <city>Trikala</city>
        <zip>42100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <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>
    <PMID>31193901</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>34974824</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Ioannis G. Fatouros</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>functional training</keyword>
  <keyword>circuit training</keyword>
  <keyword>interval training</keyword>
  <keyword>neuromuscular training</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759951
org study id: DoIT II-UTH
nct id: NCT03759951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in body mass
time frame: At baseline, at 6 months and at 12 months
description: Body mass (kg) will be measured using a beam scale
measure: Change in body mass index
time frame: At baseline, at 6 months and at 12 months
description: Body mass index will be calculated using the Quetelet's equation
measure: Change in waist circumference
time frame: At baseline, at 6 months and at 12 months
description: Waist circumference (cm) will be measured using a Gullick II tape
measure: Change in hip circumference
time frame: At baseline, at 6 months and at 12 months
description: Hip circumference (cm) will be measured using a Gullick II tape
measure: Change in waist-to-hip ratio
time frame: At baseline, at 6 months and at 12 months
description: Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement
measure: Change in body fat
time frame: At baseline and at 12 months
description: Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
measure: Change in fat mass
time frame: At baseline and at 12 months
description: Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
measure: Change in fat-free mass
time frame: At baseline and at 12 months
description: Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
measure: Change in resting metabolic rate (RMR)
time frame: At baseline, at 6 months and at 12 months
description: RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
measure: Change in maximal strength (1RM)
time frame: At baseline, at 6 months and at 12 months
description: 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
measure: Change in maximal oxygen consumption (VO2max)
time frame: At baseline, at 6 months and at 12 months
description: VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test
measure: Change in habitual physical activity (PA)
time frame: At baseline, at 3, 6, 9 and 12 months
description: Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)
measure: Change in dietary intake
time frame: At baseline, at 3, 6, 9 and 12 months
description: Dietary intake (kcal) will be assessed using 7-day diet recalls
measure: Change in body mass content (BMC)
time frame: At baseline and at 12 months
description: BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
measure: Change in body mass density (BMD)
time frame: At baseline and at 12 months
description: BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.
measure: Change in resting systolic (SBP) and diastolic (DBP) blood pressures.
time frame: At baseline, at 6 months and at 12 months
description: Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer
measure: Change in mean arterial pressure (MAP).
time frame: At baseline, at 6 months and at 12 months
description: MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3
measure: Change in resting heart rate (RHR).
time frame: At baseline, at 6 months and at 12 months
description: RHR (bpm) will be measured by pulse palpation for 60 seconds.
measure: Change in muscular endurance
time frame: At baseline, at 6 months and at 12 months
description: 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
measure: Change in flexibility
time frame: At baseline, at 6 months and at 12 months
description: Flexibility (cm) will be assessed using the modified sit-and-reach test
measure: Change in static balance
time frame: At baseline, at 6 months and at 12 months
description: Static balance (sec) will be assessed using the Sharpened Romberg test
measure: Change in functional capacity
time frame: At baseline, at 6 months and at 12 months
description: 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).
measure: Change in blood lipids
time frame: At baseline and at 12 months
description: 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
measure: Change in blood inflammatory markers
time frame: At baseline and at 12 months
description: Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits
measure: Change in cortisol
time frame: At baseline and at 12 months
description: Cortisol (nmol/L) will be measured with commercially availlable kits
measure: Change in insulin
time frame: At baseline and at 12 months
description: Insulin (mIU/L) will be measured with commercially availlable kits
measure: Change in homeostatic model assessment for insulin resistance (HOMA-IR)
time frame: At baseline and at 12 months
description: 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)
measure: Change in leptin
time frame: At baseline and at 12 months
description: Leptin (μg/L) will be measured with commercially availlable kits
measure: Change in adiponectin
time frame: At baseline and at 12 months
description: Adiponectin (μg/mL) will be measured with commercially availlable kits
measure: Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)
time frame: At baseline and at 12 months
description: IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits
measure: Change in fasting blood glucose (FBG)
time frame: At baseline and at 12 months
description: FBG (mg/dL) will be measured with commercially availlable kits
measure: Change in serum protein carbonyl levels
time frame: At baseline and at 12 months
description: Protein carbonyl (mg) will be measured with commercially availlable kits
measure: Change in thiobarbituric acid-reactive substances (TBARS)
time frame: At baseline and at 12 months
description: TBARS (nmol/mg protein) will be measured with commercially availlable kits
measure: Change in reduced (GSH) and oxidized (GSSG) glutathione
time frame: At baseline and at 12 months
description: GSH and GSSG (nmol/L) will be measured with commercially availlable kits
measure: Change in catalase activity
time frame: At baseline and at 12 months
description: Catalase activity (units) will be measured with commercially availlable kits
measure: Change in total antioxidant capacity (TAC)
time frame: At baseline and at 12 months
description: TAC (mmol/l) will be measured with commercially availlable kits
measure: Change in C-reactive protein (CRP)
time frame: At baseline and at 12 months
description: CRP (mg/L) will be measured with commercially availlable kits
measure: Change in cholecystokinin (CKK)
time frame: At baseline and at 12 months
description: CKK (ng/ml) will be measured with commercially availlable kits
measure: Change in pancreatic polypeptide (PP)
time frame: At baseline and at 12 months
description: PP (pg/ml) will be measured with commercially availlable kits
measure: Change in peptide YY (PYY)
time frame: At baseline and at 12 months
description: PYY (ng/ml) will be measured with commercially availlable kits
measure: Change in oxyntomodulin (OXM)
time frame: At baseline and at 12 months
description: OXM (pg/ml) will be measured with commercially availlable kits
measure: Change in ghrelin
time frame: At baseline and at 12 months
description: Ghrelin (pg/ml) will be measured with commercially availlable kits
measure: Change in glucagon-like peptide-1 (GLP-1)
time frame: At baseline and at 12 months
description: GLP-1 (pg/ml) will be measured with commercially availlable kits
measure: Change in appetite
time frame: At baseline, at 6 months and at 12 months
description: 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).
measure: Change in quality of life
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in exercise enjoyment
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in affective valence
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in irisin
time frame: At baseline and at 12 months
description: Irisin (ng/ml) will be measured with commercially availlable kits
measure: Change in left ventricular end-diastolic volume (LVEDV).
time frame: At baseline and at 12 months
description: LVEDV (ml) will be measured using echocardiography.
measure: Change in left ventricular end-systolic volume (LVESV).
time frame: At baseline and at 12 months
description: LVESV (ml) will be measured using echocardiography.
measure: Change in left ventricular stroke volume (LVSV).
time frame: At baseline and at 12 months
description: LVSV (ml) will be measured using echocardiography.
measure: Change in interventricular septum end diastole (IVSd).
time frame: At baseline and at 12 months
description: IVSd (mm) will be measured using echocardiography.
measure: Change in interventricular septum end diastole (IVSs).
time frame: At baseline and at 12 months
description: IVSs (mm) will be measured using echocardiography.
measure: Change in left ventricular ejection fraction (LVEF).
time frame: At baseline and at 12 months
description: LVEF (%) will be measured using echocardiography.
measure: Change in left ventricular internal diameter end diastole (LVIDd).
time frame: At baseline and at 12 months
description: LVIDd (mm) will be measured using echocardiography.
measure: Change in left ventricular internal diameter end systole (LVIDs).
time frame: At baseline and at 12 months
description: LVIDs (mm) will be measured using echocardiography.
measure: Change in left ventricular posterior wall end diastole (LVPWd).
time frame: At baseline and at 12 months
description: LVPWd (mm) will be measured using echocardiography.
measure: Change in left ventricular mass (LV mass).
time frame: At baseline and at 12 months
description: LV mass (g) will be measured using echocardiography.
measure: Change in left atrial (LA) diameter.
time frame: At baseline and at 12 months
description: LA diameter (mm) will be measured using echocardiography.
measure: Change in aortic root.
time frame: At baseline and at 12 months
description: Aortic root (mm) will be measured using echocardiography.
measure: Change in aortic valve velocity (AoV Vel).
time frame: At baseline and at 12 months
description: AoV Vel (cm/s) will be measured using echocardiography.
measure: Change in aortic valve pressure gradient (AoV PG).
time frame: At baseline and at 12 months
description: AoV PG (mmHg) will be measured using echocardiography.
measure: Change in right ventricular end diastole (RVD).
time frame: At baseline and at 12 months
description: RVD (mm) will be measured using echocardiography.
measure: Change in pulmonary artery systolic pressure (PASP).
time frame: At baseline and at 12 months
description: PASP (mmHg) will be measured using echocardiography.
measure: Change in left ventricular fractional shortening (FS).
time frame: At baseline and at 12 months
description: Fractional shortening (%) will be measured using echocardiography.
measure: Change in depression II.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in depression I.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in depression and anxiety.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in mood.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in anxiety.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in physical self.
time frame: At baseline, at 6 months and at 12 months
description: 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.
measure: Change in exercise-induced caloric expenditure
time frame: At baseline, at 6 months and at 12 months
description: Measured using a portable indirect calorimetry system
measure: Change in blood lactate concentration (BLa)
time frame: At baseline, at 6 months and at 12 months
description: 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
measure: Change in peak expiratory flow (PEF)
time frame: At baseline and at 12 months
description: PEF (l/s) will be measured using the maximum flow volume loop.
measure: Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).
time frame: At baseline and at 12 months
description: FEF25-75 (l/s) will be measured using the maximum flow volume loop.
measure: Change in forced expiratory volume at 1 s (FEV1).
time frame: At baseline and at 12 months
description: FEV1 (l) will be measured using the maximum flow volume loop.
measure: Change in forced vital capacity (FVC).
time frame: At baseline and at 12 months
description: FVC (l) will be measured using the maximum flow volume loop.
measure: Change in the ratio of FEV1/FVC.
time frame: At baseline and at 12 months
description: FEV1/FVC (%) will be measured using the maximum flow volume loop.
arm group label: Control
arm group type: Experimental
description: No intervention. Participated only in measurements at baseline, at 6 months and at 12 months.
arm group label: DoIT-1
arm group type: Experimental
description: 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.
arm group label: DoIT-2
arm group type: Experimental
description: 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.
arm group label: DoIT-3
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: DoIT-1
description: 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.
arm group label: DoIT-1
other name: Hybrid Interval Training
intervention type: Behavioral
intervention name: DoIT-2
description: 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.
arm group label: DoIT-2
other name: Hybrid Interval Training
intervention type: Behavioral
intervention name: DoIT-3
description: 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.
arm group label: DoIT-3
other name: Hybrid Interval Training
intervention type: Behavioral
intervention name: Control
description: No training will be performed during a 1-year period. Participation only in measurements.
arm group label: Control
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexios Batrakoulis, MSc
role: Principal Investigator
affiliation: SmArT Lab, DPESS, University of Thessaly
facility: 
country: Greece
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.
PMID: 31193901
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.
PMID: 34974824
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Ioannis G. Fatouros
investigator title: Professor