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Completed

NCT Number: NCT03759951

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

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.

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Key information

Conditions

High-Intensity Interval Training Body Composition Habitual Physical Activity Performance

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly

Trikala, 42100, Greece

About this study

This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:

  • Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
  • a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
  • At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
  • After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
  • After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.

All participants will be randomly assigned to the following four groups:

  • Control group (no training)
  • DoIT-1 (1 session/week)
  • DoIT-2 (2 sessions/week)
  • DoIT-3 (3 sessions/week)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inactivity (no exercise participation for ≥6 months before the study; VO2max <30 ml·kg-1·min-1)
  • age of 30-55 years
  • overweight/obese (BMI 25.0-39.9)
  • body fat percentage for women > 32% and for men > 25%
  • waist circumference for women > 80 cm and for men > 94 cm
  • medical clearance for strenuous physical training
  • no smoking for ≥6 months before the study
  • no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
  • no weight loss greater >10% of body mass before (≤6 months) the study
  • no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal, musculoskeletal or mental disorders

Exclusion criteria

Participants will be excluded from the study if they:

  • will not participate in ≥80% of total exercise sessions
  • will adhere to a nutritional intervention during the study
  • will modify the habitual physical activity levels during the study

Treatment and study plan

DoIT-1

Behavioral

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.

Other names: Hybrid Interval Training

DoIT-2

Behavioral

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.

Other names: Hybrid Interval Training

DoIT-3

Behavioral

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.

Other names: Hybrid Interval Training

Control

Behavioral

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

Primary outcomes

  1. Change in body mass

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

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

  2. Change in body mass index

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

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

  3. Change in waist circumference

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

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

  4. Change in hip circumference

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

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

  5. Change in waist-to-hip ratio

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

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

  6. Change in body fat

    Time frame: At baseline and at 12 months

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

  7. Change in fat mass

    Time frame: At baseline and at 12 months

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

  8. Change in fat-free mass

    Time frame: At baseline and at 12 months

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

  9. Change in resting metabolic rate (RMR)

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

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

  10. Change in maximal strength (1RM)

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

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

  11. Change in maximal oxygen consumption (VO2max)

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

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

  12. Change in habitual physical activity (PA)

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

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

  13. Change in dietary intake

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

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

  14. Change in body mass content (BMC)

    Time frame: At baseline and at 12 months

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

  15. Change in body mass density (BMD)

    Time frame: At baseline and at 12 months

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

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

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

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

  17. Change in mean arterial pressure (MAP).

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

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

  18. Change in resting heart rate (RHR).

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

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

  19. Change in muscular endurance

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

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

  20. Change in flexibility

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

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

  21. Change in static balance

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

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

  22. Change in functional capacity

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

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

  23. Change in blood lipids

    Time frame: At baseline and at 12 months

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

  24. Change in blood inflammatory markers

    Time frame: At baseline and at 12 months

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

  25. Change in cortisol

    Time frame: At baseline and at 12 months

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

  26. Change in insulin

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

  28. Change in leptin

    Time frame: At baseline and at 12 months

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

  29. Change in adiponectin

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

  31. Change in fasting blood glucose (FBG)

    Time frame: At baseline and at 12 months

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

  32. Change in serum protein carbonyl levels

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

  35. Change in catalase activity

    Time frame: At baseline and at 12 months

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

  36. Change in total antioxidant capacity (TAC)

    Time frame: At baseline and at 12 months

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

  37. Change in C-reactive protein (CRP)

    Time frame: At baseline and at 12 months

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

  38. Change in cholecystokinin (CKK)

    Time frame: At baseline and at 12 months

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

  39. Change in pancreatic polypeptide (PP)

    Time frame: At baseline and at 12 months

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

  40. Change in peptide YY (PYY)

    Time frame: At baseline and at 12 months

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

  41. Change in oxyntomodulin (OXM)

    Time frame: At baseline and at 12 months

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

  42. Change in ghrelin

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

  44. Change in appetite

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

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

  45. Change in quality of life

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

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

  46. Change in exercise enjoyment

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

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

  47. Change in affective valence

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

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

  48. Change in irisin

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

    LVEDV (ml) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVESV (ml) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVSV (ml) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    IVSd (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    IVSs (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVEF (%) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVIDd (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVIDs (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LVPWd (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    LV mass (g) will be measured using echocardiography.

  59. Change in left atrial (LA) diameter.

    Time frame: At baseline and at 12 months

    LA diameter (mm) will be measured using echocardiography.

  60. Change in aortic root.

    Time frame: At baseline and at 12 months

    Aortic root (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

    AoV PG (mmHg) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    RVD (mm) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    PASP (mmHg) will be measured using echocardiography.

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

    Time frame: At baseline and at 12 months

    Fractional shortening (%) will be measured using echocardiography.

  66. Change in depression II.

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

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

  67. Change in depression I.

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

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

  68. Change in depression and anxiety.

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

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

  69. Change in mood.

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

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

  70. Change in anxiety.

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

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

  71. Change in physical self.

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

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

Secondary outcomes

  1. Change in exercise-induced caloric expenditure

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

    Measured using a portable indirect calorimetry system

  2. Change in blood lactate concentration (BLa)

    Time frame: 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

  3. Change in peak expiratory flow (PEF)

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

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

    Time frame: At baseline and at 12 months

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

  6. Change in forced vital capacity (FVC).

    Time frame: At baseline and at 12 months

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

  7. Change in the ratio of FEV1/FVC.

    Time frame: At baseline and at 12 months

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

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2018
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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