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

Keywords

• functional training
• circuit training
• interval training
• neuromuscular training

Lead sponsor

University of Thessaly is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Study arms

• Experimental
  Control

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

  Behavioral: Control

• Experimental
  DoIT-1

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

  Behavioral: DoIT-1

• Experimental
  DoIT-2

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

  Behavioral: DoIT-2

• Experimental
  DoIT-3

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

  Behavioral: DoIT-3

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.

  Also known as: Hybrid Interval Training

• 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.

  Also known as: Hybrid Interval Training

• 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.

  Also known as: Hybrid Interval Training

• BehavioralControl

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

Primary outcomes

1. Change in body mass

   Body mass (kg) will be measured using a beam scale

   Time frame: At baseline, at 6 months and at 12 months

2. Change in body mass index

   Body mass index will be calculated using the Quetelet's equation

   Time frame: At baseline, at 6 months and at 12 months

3. Change in waist circumference

   Waist circumference (cm) will be measured using a Gullick II tape

   Time frame: At baseline, at 6 months and at 12 months

4. Change in hip circumference

   Hip circumference (cm) will be measured using a Gullick II tape

   Time frame: At baseline, at 6 months and at 12 months

5. Change in waist-to-hip ratio

   Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement

   Time frame: At baseline, at 6 months and at 12 months

6. Change in body fat

   Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)

   Time frame: At baseline and at 12 months

7. Change in fat mass

   Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)

   Time frame: At baseline and at 12 months

8. Change in fat-free mass

   Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)

   Time frame: At baseline and at 12 months

9. Change in resting metabolic rate (RMR)

   RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system

   Time frame: At baseline, at 6 months and at 12 months

10. Change in maximal strength (1RM)

    1RM (kg) for the lower body will be measured bilaterally on a horizontal leg press, seated leg extension and lying leg curl machines while 1RM (kg) for the upper body will be measured on a seated chest press and lat pull-down machines

    Time frame: At baseline, at 6 months and at 12 months

11. Change in maximal oxygen consumption (VO2max)

    VO2max (ml/kg/min) will be estimated using a low-risk, low-cost and single-stage submaximal treadmill walking test

    Time frame: At baseline, at 6 months and at 12 months

12. Change in habitual physical activity (PA)

    Seven-day habitual PA (MET-min/week) will be assessed using the International Physical Activity Questionnaire (IPAQ)

    Time frame: At baseline, at 3, 6, 9 and 12 months

13. Change in dietary intake

    Dietary intake (kcal) will be assessed using 7-day diet recalls

    Time frame: At baseline, at 3, 6, 9 and 12 months

14. Change in body mass content (BMC)

    BMC (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.

    Time frame: At baseline and at 12 months

15. Change in body mass density (BMD)

    BMD (g) will be assessed by dual-energy X-ray absorptiometry (DXA) of the total body and non-dominant hip.

    Time frame: At baseline and at 12 months

16. Change in resting systolic (SBP) and diastolic (DBP) blood pressures.

    Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer

    Time frame: At baseline, at 6 months and at 12 months

17. Change in mean arterial pressure (MAP).

    MAP (mmHg) will be calculated using the following equation: MAP = SBP + (DBP × DBP) / 3

    Time frame: At baseline, at 6 months and at 12 months

18. Change in resting heart rate (RHR).

    RHR (bpm) will be measured by pulse palpation for 60 seconds.

    Time frame: At baseline, at 6 months and at 12 months

19. Change in muscular endurance

    Muscular endurance (repetitions until muscle failure) will be assessed using timed tests (60 sec) for the abdominal musculature, upper and lower body. The tests will include partial curl-up, push-up for males and modified push-up for females (kneeling position) and modified chair squat, respectively

    Time frame: At baseline, at 6 months and at 12 months

20. Change in flexibility

    Flexibility (cm) will be assessed using the modified sit-and-reach test

    Time frame: At baseline, at 6 months and at 12 months

21. Change in static balance

    Static balance (sec) will be assessed using the Sharpened Romberg test

    Time frame: At baseline, at 6 months and at 12 months

22. Change in functional capacity

    Functional capacity will be assessed using a movement-based screening tool titled Functional Movement Screening (FMS). The FMS will be consisted of 7 movement tasks that will be scored from 0 to 3 points and the sum will create score ranging from 0 to 21 points (0 = pain with pattern regardless of quality, 1 = unable to perform pattern, 2 = able to perform pattern with compensation/imperfection, 3 = able to perform pattern as directed).

    Time frame: At baseline, at 6 months and at 12 months

23. Change in blood lipids

    Total serum cholesterol (mmol/L), triglycerides (mmol/L), low-density lipoprotein (mmol/L) and high-density lipoprotein (mmol/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

24. Change in blood inflammatory markers

    Cytokines, lipocalines, CRP, oxidative stress markers will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

25. Change in cortisol

    Cortisol (nmol/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

26. Change in insulin

    Insulin (mIU/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

27. Change in homeostatic model assessment for insulin resistance (HOMA-IR)

    HOMA-IR will be measured with commercially availlable kits. ΗΟΜΑ score will be calculated using the equation HOMA-IR = fasting insulin (mIU/L) x fasting glucose (mg/dL) / 405. HOMA-IR score will be classified using the following range: normal insulin resistance \< 3, moderate insulin resistance 3-5, severe insulin resistance \> 5)

    Time frame: At baseline and at 12 months

28. Change in leptin

    Leptin (μg/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

29. Change in adiponectin

    Adiponectin (μg/mL) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

30. Change in interleukin 1 beta (IL-1b) and interleuking 6 (IL-6)

    IL-1b and IL-6 (pg/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

31. Change in fasting blood glucose (FBG)

    FBG (mg/dL) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

32. Change in serum protein carbonyl levels

    Protein carbonyl (mg) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

33. Change in thiobarbituric acid-reactive substances (TBARS)

    TBARS (nmol/mg protein) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

34. Change in reduced (GSH) and oxidized (GSSG) glutathione

    GSH and GSSG (nmol/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

35. Change in catalase activity

    Catalase activity (units) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

36. Change in total antioxidant capacity (TAC)

    TAC (mmol/l) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

37. Change in C-reactive protein (CRP)

    CRP (mg/L) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

38. Change in cholecystokinin (CKK)

    CKK (ng/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

39. Change in pancreatic polypeptide (PP)

    PP (pg/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

40. Change in peptide YY (PYY)

    PYY (ng/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

41. Change in oxyntomodulin (OXM)

    OXM (pg/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

42. Change in ghrelin

    Ghrelin (pg/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

43. Change in glucagon-like peptide-1 (GLP-1)

    GLP-1 (pg/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

44. Change in appetite

    The Visual Analog Scale (VAS) will be used to measure perceived hunger, satiety, and individual's own interpretation of their hunger sensations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).

    Time frame: At baseline, at 6 months and at 12 months

45. Change in quality of life

    Quality of life will be assessed using the physical and mental component subscales of the Greek 36-Item Short-Form Health Survey (SF-36). The scores on both component subscales of the SF-36 will range from 0 to 100, with higher scores indicating better health status while the minimal clinically important difference will be 2 points.

    Time frame: At baseline, at 6 months and at 12 months

46. Change in exercise enjoyment

    Exercise enjoyment will be assessed using the Exercise Enjoyment Scale (EES), which is a single-item 7-point scale to assess enjoyment pre-, during, and post-exercise ranging from "not at all" at 1 to "extremely" at 7.

    Time frame: At baseline, at 6 months and at 12 months

47. Change in affective valence

    Affective responses to exercise will be assessed using the Feeling Scale (FS), which is a single-item 11-point scale to assess feeling of pleasure pre-, during, and post-exercise training ranging from "very good" at -5 to "very bad" at 5.

    Time frame: At baseline, at 6 months and at 12 months

48. Change in irisin

    Irisin (ng/ml) will be measured with commercially availlable kits

    Time frame: At baseline and at 12 months

49. Change in left ventricular end-diastolic volume (LVEDV).

    LVEDV (ml) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

50. Change in left ventricular end-systolic volume (LVESV).

    LVESV (ml) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

51. Change in left ventricular stroke volume (LVSV).

    LVSV (ml) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

52. Change in interventricular septum end diastole (IVSd).

    IVSd (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

53. Change in interventricular septum end diastole (IVSs).

    IVSs (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

54. Change in left ventricular ejection fraction (LVEF).

    LVEF (%) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

55. Change in left ventricular internal diameter end diastole (LVIDd).

    LVIDd (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

56. Change in left ventricular internal diameter end systole (LVIDs).

    LVIDs (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

57. Change in left ventricular posterior wall end diastole (LVPWd).

    LVPWd (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

58. Change in left ventricular mass (LV mass).

    LV mass (g) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

59. Change in left atrial (LA) diameter.

    LA diameter (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

60. Change in aortic root.

    Aortic root (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

61. Change in aortic valve velocity (AoV Vel).

    AoV Vel (cm/s) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

62. Change in aortic valve pressure gradient (AoV PG).

    AoV PG (mmHg) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

63. Change in right ventricular end diastole (RVD).

    RVD (mm) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

64. Change in pulmonary artery systolic pressure (PASP).

    PASP (mmHg) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

65. Change in left ventricular fractional shortening (FS).

    Fractional shortening (%) will be measured using echocardiography.

    Time frame: At baseline and at 12 months

66. Change in depression II.

    Depression will be measured using the Patient Health Questionnaire (PHQ-9)), which is a self-administered instrument consisiting of 9 multiple-choice questions scored from 0 to 3. Higher total scores indicate higher depression severity.

    Time frame: At baseline, at 6 months and at 12 months

67. Change in depression I.

    Depression will be measured using the Beck Depression Inventory (BDI), which is a self-report questionnaire consisiting of 21 multiple-choice questions scored from 0 to 3. Higher total scores indicate more severe depressive symptoms.

    Time frame: At baseline, at 6 months and at 12 months

68. Change in depression and anxiety.

    Both depression and anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater anxiety and depression.

    Time frame: At baseline, at 6 months and at 12 months

69. Change in mood.

    Mood will be measured using the Profile of Mood States (POMS) questionnaire, which uses a unipolar scale to rate the extent to which they are experiencing or have experienced 20 affect states in the past week using a 5-point scale (0 = not at all, 4 = extremely). Higher scores indicate greater negative mood.

    Time frame: At baseline, at 6 months and at 12 months

70. Change in anxiety.

    Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which is an instrument that has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    Time frame: At baseline, at 6 months and at 12 months

71. Change in physical self.

    Physical self will be measured using the Physical Self-Perception Profile (PSPP), which is an instrument with 30 questions comprising five 6-item subscales. Each item has a four-point structured-alternative format. Scores range from 6 to 24 on each subscale, with high scores representing positive perceptions. Half of the items are worded in the negative direction.

    Time frame: At baseline, at 6 months and at 12 months

Secondary outcomes

1. Change in exercise-induced caloric expenditure

   Measured using a portable indirect calorimetry system

   Time frame: At baseline, at 6 months and at 12 months

2. Change in blood lactate concentration (BLa)

   BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits. Blood samples will be collected pre-, mid- and post-exercise session (single bout) at 3 min post-exercise

   Time frame: At baseline, at 6 months and at 12 months

3. Change in peak expiratory flow (PEF)

   PEF (l/s) will be measured using the maximum flow volume loop.

   Time frame: At baseline and at 12 months

4. Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).

   FEF25-75 (l/s) will be measured using the maximum flow volume loop.

   Time frame: At baseline and at 12 months

5. Change in forced expiratory volume at 1 s (FEV1).

   FEV1 (l) will be measured using the maximum flow volume loop.

   Time frame: At baseline and at 12 months

6. Change in forced vital capacity (FVC).

   FVC (l) will be measured using the maximum flow volume loop.

   Time frame: At baseline and at 12 months

7. Change in the ratio of FEV1/FVC.

   FEV1/FVC (%) will be measured using the maximum flow volume loop.

   Time frame: At baseline and at 12 months

Publications

• Batrakoulis A, Fatouros IG, Chatzinikolaou A, Draganidis D, Georgakouli K, Papanikolaou K, Deli CK, Tsimeas P, Avloniti A, Syrou N, Jamurtas AZ. Dose-response effects of high-intensity interval neuromuscular exercise training on weight loss, performance, health and quality of life in inactive obese adults: Study rationale, design and methods of the DoIT trial. Contemp Clin Trials Commun. 2019 May 23;15:100386. doi: 10.1016/j.conctc.2019.100386. eCollection 2019 Sep. PubMed 31193901 ↗
• 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. PubMed 34974824 ↗