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临床试验/NCT03759951
NCT03759951已完成不适用

The Dose-response Effect of High-intensity Interval Neuromuscular Training on Health, Performance and Quality of Life in Overweight/Obese Adults: The DoIT Trial

University of Thessaly2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Change in body mass

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in body mass

时间窗: At baseline, at 6 months and at 12 months

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

Change in body mass index

时间窗: At baseline, at 6 months and at 12 months

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

Change in waist-to-hip ratio

时间窗: At baseline, at 6 months and at 12 months

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

Change in body fat

时间窗: At baseline and at 12 months

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

Change in fat-free mass

时间窗: At baseline and at 12 months

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

Change in resting metabolic rate (RMR)

时间窗: At baseline, at 6 months and at 12 months

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

Change in maximal strength (1RM)

时间窗: At baseline, at 6 months and at 12 months

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

Change in maximal oxygen consumption (VO2max)

时间窗: At baseline, at 6 months and at 12 months

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

Change in body mass content (BMC)

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline, at 6 months and at 12 months

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

Change in fat mass

时间窗: At baseline and at 12 months

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

Change in static balance

时间窗: At baseline, at 6 months and at 12 months

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

Change in blood inflammatory markers

时间窗: At baseline and at 12 months

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

Change in exercise enjoyment

时间窗: At baseline, at 6 months and at 12 months

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

Change in left ventricular stroke volume (LVSV).

时间窗: At baseline and at 12 months

LVSV (ml) will be measured using echocardiography.

Change in left ventricular mass (LV mass).

时间窗: At baseline and at 12 months

LV mass (g) will be measured using echocardiography.

Change in physical self.

时间窗: At baseline, at 6 months and at 12 months

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

Change in waist circumference

时间窗: At baseline, at 6 months and at 12 months

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

Change in hip circumference

时间窗: At baseline, at 6 months and at 12 months

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

Change in muscular endurance

时间窗: At baseline, at 6 months and at 12 months

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

Change in cortisol

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

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

Change in adiponectin

时间窗: At baseline and at 12 months

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

Change in fasting blood glucose (FBG)

时间窗: At baseline and at 12 months

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

Change in total antioxidant capacity (TAC)

时间窗: At baseline and at 12 months

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

Change in cholecystokinin (CKK)

时间窗: At baseline and at 12 months

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

Change in pancreatic polypeptide (PP)

时间窗: At baseline and at 12 months

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

Change in habitual physical activity (PA)

时间窗: At baseline, at 3, 6, 9 and 12 months

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

Change in body mass density (BMD)

时间窗: At baseline and at 12 months

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

Change in mean arterial pressure (MAP).

时间窗: At baseline, at 6 months and at 12 months

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

Change in resting heart rate (RHR).

时间窗: At baseline, at 6 months and at 12 months

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

Change in flexibility

时间窗: At baseline, at 6 months and at 12 months

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

Change in thiobarbituric acid-reactive substances (TBARS)

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

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

Change in C-reactive protein (CRP)

时间窗: At baseline and at 12 months

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

Change in peptide YY (PYY)

时间窗: At baseline and at 12 months

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

Change in oxyntomodulin (OXM)

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

LVIDs (mm) will be measured using echocardiography.

Change in left atrial (LA) diameter.

时间窗: At baseline and at 12 months

LA diameter (mm) will be measured using echocardiography.

Change in dietary intake

时间窗: At baseline, at 3, 6, 9 and 12 months

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

Change in functional capacity

时间窗: At baseline, at 6 months and at 12 months

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

Change in blood lipids

时间窗: At baseline and at 12 months

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

Change in insulin

时间窗: At baseline and at 12 months

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

Change in serum protein carbonyl levels

时间窗: At baseline and at 12 months

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

Change in appetite

时间窗: At baseline, at 6 months and at 12 months

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

Change in affective valence

时间窗: At baseline, at 6 months and at 12 months

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

Change in irisin

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

LVEDV (ml) will be measured using echocardiography.

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

时间窗: At baseline and at 12 months

LVESV (ml) will be measured using echocardiography.

Change in leptin

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

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

Change in catalase activity

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

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

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

时间窗: At baseline and at 12 months

LVIDd (mm) will be measured using echocardiography.

Change in aortic valve pressure gradient (AoV PG).

时间窗: At baseline and at 12 months

AoV PG (mmHg) will be measured using echocardiography.

Change in ghrelin

时间窗: At baseline and at 12 months

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

Change in quality of life

时间窗: At baseline, at 6 months and at 12 months

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

Change in interventricular septum end diastole (IVSd).

时间窗: At baseline and at 12 months

IVSd (mm) will be measured using echocardiography.

Change in aortic root.

时间窗: At baseline and at 12 months

Aortic root (mm) will be measured using echocardiography.

Change in aortic valve velocity (AoV Vel).

时间窗: At baseline and at 12 months

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

Change in left ventricular fractional shortening (FS).

时间窗: At baseline and at 12 months

Fractional shortening (%) will be measured using echocardiography.

Change in depression II.

时间窗: At baseline, at 6 months and at 12 months

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

Change in interventricular septum end diastole (IVSs).

时间窗: At baseline and at 12 months

IVSs (mm) will be measured using echocardiography.

Change in left ventricular ejection fraction (LVEF).

时间窗: At baseline and at 12 months

LVEF (%) will be measured using echocardiography.

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

时间窗: At baseline and at 12 months

LVPWd (mm) will be measured using echocardiography.

Change in pulmonary artery systolic pressure (PASP).

时间窗: At baseline and at 12 months

PASP (mmHg) will be measured using echocardiography.

Change in depression I.

时间窗: At baseline, at 6 months and at 12 months

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

Change in depression and anxiety.

时间窗: At baseline, at 6 months and at 12 months

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

Change in mood.

时间窗: At baseline, at 6 months and at 12 months

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

Change in right ventricular end diastole (RVD).

时间窗: At baseline and at 12 months

RVD (mm) will be measured using echocardiography.

Change in anxiety.

时间窗: 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.

次要结局

  • Change in exercise-induced caloric expenditure(At baseline, at 6 months and at 12 months)
  • Change in blood lactate concentration (BLa)(At baseline, at 6 months and at 12 months)
  • Change in the ratio of FEV1/FVC.(At baseline and at 12 months)
  • Change in peak expiratory flow (PEF)(At baseline and at 12 months)
  • Change in forced expiratory flow between 25 and 75% of vital capacity (FEF25-75).(At baseline and at 12 months)
  • Change in forced expiratory volume at 1 s (FEV1).(At baseline and at 12 months)
  • Change in forced vital capacity (FVC).(At baseline and at 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ioannis G. Fatouros

Professor

University of Thessaly

研究点 (2)

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