A Proposed Design for a Dose-Response Clinical Trial in High Risk Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in White blood cells (WBC)
研究概览
简要总结
The purpose of this randomized controlled study will be to inestigate the relationship between recreational football training at various training volumes and the health responses of middle-aged participants at high risk for metabolic and / or cardiovascular disease.
详细描述
A controlled, randomized, four-group, repeated-measures clinical trial will be apllied. Males and females middle-aged volunteers (age 40-60 years) will participate in the present study. The participants will not suffer from any musculoskeletal injuries that will limit their ability to perform the exercise protocols.
The study will be consisted of the following stages:
- In the first phase all participants will sign an informed consent form after they will be informed about all benefits and risks of this study and they will sign a recent historical of musculoskeletal injury or illness form.
- Initial testing: body weight (BW) and height, BMI, electrocardiogram (ECG), RMR, daily physical activity (PA) and daily nutritional intake (participants will be instructed by a dietitian how to record a 7 days diet recalls).
- 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 and during study. 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. Fasting blood samples will be collected by venipuncture using a disposable needle (20-gauge) in order to etsimate the lipid profile (TCHO, LDL, HDH, TG), fasting glucose and insulin, Hemoglobin (HbA1c) test in order to measure the amount of blood sugar (glucose) attached to hemoglobin and HOMA-IR, muscle damage markers (CK), inflammation markers (WBC and GRA), oxidative stress markers (PC, GSH, GSSG, ΤΑC and CAT), cortisol, blood test (HGB, HCT, LYM, MON, PLT and RBC) and cytokines indicators (IL-1b, IL-6 and CRP). The following will be included in the assessment procedures: Body weight (BW) and Height, body mass index (BMI), Body composition (DXA method), the circumferences of waist and hip in order to estimate the waist hip ratio (WHR). Also, the volunteers will participate in health-related measurements as: Bone mineral density, Bone mineral content, Hip structural analysis, Arterial blood pressure- Mean arterial blood pressure, resting heart rate, ultrasonography for heart and blood vessels and functional movement screen (FMS). The performance measurements in baseline testing are included the following procedures: maximal oxygen consumption and heart rate maximum (Vo2max-HRmax prediction using the Balke test), strength (1- repetition maximum in leg press and chest press), the knee-hip and ankle range of motion will be determined using a goniometer, the balance and gait speed indicator will be determine using Romberg's test and short physical performance battery tool respectively. Also, muscle endurance tests will be used and flexibility will be measured using sit and reach test. 10m and 30m sprint test will be measured in the same period using photocells device and the conter movement jump will be measured using a force platform. Measurements of well-being (vitality, quality of life, flow, depression, behavioral regulations in exercise and pgycological well being) will be performed using modified questionnaires.
- After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The footbal training that will be used throughout the 6 months intervention will be consisted of wurm up (7-10 minutes), Tecnhical drills (5-8 minutes), fitness exercises (5-10 minutes), football games (30 minutes) and recovery period (5 minutes). During the sessions will be assessed the change in Heart rate using a heart rate monitor and the field activity will be recorded using a global positiong system (GPS). At the end of every session will be used Borg scale in monitoring progress and mode of exercise. Also, following a single training session both at pre and post training will be measured the delayed onset muscle soreness scale (DOMS), the Creatine Kinase activity, the isometric force of knee extensors and knee flexors, the eccentric and concentric peak torque using isokinetic dynamometer, the counter movement jumb ability and blood samples will be collected in order to estimate biochemical indicators (Oxidative stress and inflammatory response). Fianlly, the energy expenditure during training will be measured via blood lactate and oxygen consumption.
- After 6 months of football 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)
- FIM-1 (1 session/week)
- FIM-2 (2 sessions/week)
- FIM-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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants Vo2max <30ml/kg/min
- •age of 40-60 years
- •medical clearance for strenuous physical training
- •Free of chronic diseases
- •Free of musculoskeletal injury
- •waist circumference 80≥ cm for female and 94≥ cm for Male participants
- •no weight loss greater >10% of body mass before (≤6 months) the study
- •no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
- •Additionaly the participants will have at least two of the following risk factors
- •overweight/obese (BMI 25.0-35.0)
- •Fasting Glucose≥100 mg/dl
- •Blood Pressure≥120/80 mmHg
- •Total Cholesterol≥190 mg/dl
- •High Desnity lipoprotein< 35 mg/dl for male and < 39 mg/dl for female participants
- •Low Density Lipoprotein≥100 mg/dl
- •Triglycerides≥150 mg/dl
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
- •Musculoskeletal injury
- •Chronic disease
结局指标
主要结局
Change in White blood cells (WBC)
时间窗: At baseline and at 6 months
White blood cells will be measured using an automatic blood analyzer
Change in Body mass index
时间窗: At baseline and at 6 months
Body mass index wil be calculated using the Quetelet's equation
Change in Body fat
时间窗: At baseline and at 6 months
Body fat (%) 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 24 hours, 48 hours and 72 hours after
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
Change in body mass content (BMC)
时间窗: At baseline and at 6 months
BMC (g) will be assessed by dual energy X-ray absorptiometry (DXA) of the total body, hip of non-dominant and dominant limb, spine and wrist
Change in Waist circumference
时间窗: At baseline and at 6 months
Waist circumference (cm) will be measured using a Gullick II tape
Change in maximal strength (1RM)
时间窗: At baseline and at 6 months
1RM (kg) for the lower body will be measured bilaterally on a horizontal leg press, while 1RM (kg) for the upper body will be measured on a horizontal chest press
Change in dietary intake
时间窗: At baseline and at 6 months
Dietary intake (kcal) will be assessed using 7-day recalls
Change in maximal heart rate (MaxHR)
时间窗: At baseline and at 6 months
MaxHR will be estimated using a low-risk submaximal treadmill walking test
Change in Interleukin 6 (IL-6)
时间窗: At baseline and at 6 months
IL-6 (pg/ml) will be measured with commercially available kits
Change in oxidized glutathione (GSSG)
时间窗: At baseline and at 6 months
GSSG (nmol/L) will be measured in red blood cells with commercially available kits
Change in red blood cells (RBC)
时间窗: At baseline and at 6 months
RBC concentration will be measured using an automatic blood analyzer
Change in Lymphocytes (LYM)
时间窗: At baseline and at 6 months
LYM concentration will be measured using an automatic blood analyzer
Change in Hemoglobin A1c (HbA1c)
时间窗: At baseline and at 6 months
HbA1c concentration will be measured with commercially available kits
Change in Hip circumference
时间窗: At baseline and at 6 months
Hip circumference (cm) will be measured using a Gullick II tape
Change in maximal oxygen consumption (VO2max)
时间窗: At baseline and at 6 months
VO2max (ml/kg/min) will be estimated using a low-risk submaximal treadmill walking test
Change in daily physical activity
时间窗: At baseline and at 6 months
Daily physical activity will be assessed accelerometry device
Change in body mass density (BMD)
时间窗: At baseline and at 6 months
BMD (g) will be assessed by dual energy X-ray absorptiometry (DXA) of the total body, hip of non-dominant and dominant limb, spine and wrist
Change in knee, hip and ankle range of motion
时间窗: At baseline and at 6 months
Knee, hip and ankle range of motion will be assessed using manual goniometer
Change in flexibility
时间窗: At baseline and at 6 months
Flexibility (cm) will be assessed using the modified sit-and-reach test
Change in Interleukin 1 beta (IL-1b)
时间窗: At baseline and at 6 months
IL-1b (pg/ml) will be measured with commercially available kits
Change in fasting blood glucose (FBG)
时间窗: At baseline and at 6 months
FBG (mg/dL) will be measured with commercially available kits
Change in Uric acid (UA)
时间窗: At baseline and at 6 months
UA concentration will be measured in plasma with commercially available kits
Change in isometric knee flexors peak torque
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
isometric knee flexors peak torque will be assessed on an isokinetic dynamometer
Change in eccentric knee extensors peak torque
时间窗: At baseline and at 6 months
eccentric knee extensors peak torque will be assessed on an isokinetic dynamometer
Change in counter movement jump flight time (CMJf)
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
CMJf (ms) will be assessed using a force platform with each foot parallel on platform
Change in monocytes (MON)
时间窗: At baseline and at 6 months
PLT concentration will be measured using an automatic blood analyzer
Change in fat mass
时间窗: At baseline and at 6 months
Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Change in fat-free mass
时间窗: At baseline and at 6 months
Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Change in functional mobility
时间窗: At baseline and at 6 months
Functional mobility (sec) will be assessed using Gait speed test
Change in homeostatic model assessemnet for insulin resistance (HOMA-IR)
时间窗: At baseline and at 6 months
HOMA-IR will be measured with commercially available 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 Protein Carbonyls (PC) concentration
时间窗: At baseline and at 6 months
PC (mg) will be measured in red blood cells with commercially available kits
Change in C - reactive protein (CRP)
时间窗: At baseline and at 6 months
CRP (mg/L) will be measured with commercially available kits
Change in Granulocyte (GRA)
时间窗: At baseline and at 6 months
GRA concentration will be measured using an automatic blood analyzer
Change in Platelet (PLT)
时间窗: At baseline and at 6 months
PLT concentration will be measured using an automatic blood analyzer
Change in body mass
时间窗: At baseline and at 6 months
Body mass (kg) wil be measured using a beam balance
Change in Waist-to-hip ratio
时间窗: At baseline and at 6 months
Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement
Change in hip structural analysis
时间窗: At baseline and at 6 months
hip structural analysis will be assessed by dual energy X-ray absorptiometry (DXA) of the total body, hip of non-dominant and dominant limb, spine and wrist
Change in blood lipids
时间窗: At baseline and at 6 months
Total serum cholesterol (mmol/L), triglycerides (mmol/L), low density lipoprotein (mmol/L) will be measured with commercially availlable kits.
Change in muscle endurance
时间窗: At baseline and at 6 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) respectively.
Change in glutathione (GSH)
时间窗: At baseline and at 6 months
GSH (nmol/L) will be measured in red blood cells with commercially available kits
Change in resting systolic (SBP) and diastolic (DBP) blood pressures
时间窗: At baseline and at 6 months
Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer
Change in mean arterial pressure (MAP)
时间窗: At baseline and at 6 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 and at 6 months
RHR will be measured by pulse palpation for 60 seconds
Change in functional capacity
时间窗: At baseline and at 6 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 static balance
时间窗: At baseline and at 6 months
Static balance will be assessed using the Sharened Romberg test
Change inTotal antioxidant capacity (TAC)
时间窗: At baseline and at 6 months
TAC will be will be measured with commercially available kits
Change in Cortisol
时间窗: At baseline and at 6 months
Cortisol (nmol/L) will be measured with commercially available kits
Change in insulin
时间窗: At baseline and at 6 months
Insulin (mlU/L) will be measured with commercially available kits
Change in Catalase (CAT) activity
时间窗: At baseline and at 6 months
CAT activity (units) will be measured in red blood cells with commercially available kits
Change in eccentric knee flexors peak torque
时间窗: At baseline and at 6 months
eccentric knee flexors peak torque will be assessed on an isokinetic dynamometer
Change in concentric knee flexors peak torque
时间窗: At baseline and at 6 months
concentric knee flexors peak torque will be assessed on an isokinetic dynamometer
Change in counter movement jump height (CMJh)
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
CMJh (cm) will be assessed using a force platform with each foot parallel on platform
Change in sprint time of 10m
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Sprint time (sec) will be assessed over a 10 m distance ising light cells
Change in Cratine Kinase (CK) concentration
时间窗: At 6 months and 24 hours, 48 hours and 72 hours after
CK concentration will be measured with commercially available kits
Change in Hematocrit (HCT)
时间窗: At baseline and at 6 months
HCT concentration will be measured using an automatic blood analyzer
Change in Hemoglobin (HGB)
时间窗: At baseline and at 6 months
HGB concentration will be measured using an automatic blood analyzer
Change in concentric knee extensors peak torque
时间窗: At baseline and at 6 months
concentric knee extensors peak torque will be assessed on an isokinetic dynamometer
Change in left ventricular end-diastolic volume (LVEDV)
时间窗: At baseline and at 6 months
LVEDV (ml) will be measured using echocardiography
Change in interventicular septum and diastole (IVSd)
时间窗: At baseline and at 6 months
IVSd will be measured using echocardiography
Change in isometric knee extensors peak torque
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
isometric knee extensors peak torque will be assessed on an isokinetic dynamometer
Change in counter movement jump power (CMJp)
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
CMJp (w/kg) will be assessed using a force platform with each foot parallel on platform
Change in left ventricular stroke volume (LVSV)
时间窗: At baseline and at 6 months
LVSV (ml) will be measured using echocardiography
Change in left ventricular internal diameter and diastole (LVIDd)
时间窗: At baseline and at 6 months
LVIDd (mm) will be measured using echocardiography
Change in pulmonary artery systolic pressure (PASP)
时间窗: At baseline and at 6 months
PASP (mmHg) will be measured using echocardiography
Change vitality
时间窗: At baseline and at 6 months
Vitality will be assessed using Subjective Vitality Scales (SVS) via 6 items. Each item is rated on a 6-point scale (1 = not at all true, 2 = not true, 3 = almost not true, 4 = almost true, 5 = true, 6 = very true). The total score ranges from 6 to 36 with a higher score indicating a better condition.
Change in sprint time of 30m
时间窗: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Sprint time (sec) will be assessed over a 30 m distance ising light cells
Change in interventicular septum and systole (IVSs)
时间窗: At baseline and at 6 months
IVSs will be measured using echocardiography
Change in left ventricular mass (LV mass)
时间窗: At baseline and at 6 months
LV mass (g) will be measured using echocardiography
Change in aortic valve velocity (AoV Vel)
时间窗: At baseline and at 6 months
AoV Vel (cm/s) will be measured using echocardiography
Change in left ventricular end-systolic volume (LVESV)
时间窗: At baseline and at 6 months
LVESV (ml) will be measured using echocardiography
Change in left ventricular ejection fraction (LVEF)
时间窗: At baseline and at 6 months
LVEF (%) will be measured using echocardiography
Change in left ventricular internal diameter and systole (LVIDs)
时间窗: At baseline and at 6 months
LVIDs (mm) will be measured using echocardiography
Change in aortic root
时间窗: At baseline and at 6 months
Aortic root (mm) will be measured using echocardiography
Change in right ventricular end diastole 1 (RVD1)
时间窗: At baseline and at 6 months
RVD1 (mm) will be measured using echocardiography
Change in tricuspid annular systolic velocity (TV S') of Right ventricular functionality
时间窗: At baseline and at 6 months
TV S' (mm) will be measured using echocardiography
Change in left ventricular fractional shortenning (FS)
时间窗: At baseline and at 6 months
Fractional shortenning (%) will be measured using echocardiography
Change in left ventricular Global Longitudinal strain (GLS)
时间窗: At baseline and at 6 months
GLS (%) will be measured using echocardiography
Change in pshycological well - being
时间窗: At baseline and at 6 months
Psychological well - being will be assessed using The General Health Questionnaire (GHQ-12) via 12 items
Change in motivation
时间窗: At baseline and at 6 months
E xercise behavioral will be assessed using the behavioral regulation in (BREQ-2) via 19 items questionnaire. All the 19 items were positive scored, and it was rated on a five-point for each item from 0 (not true for me) to 4 (very true for me) to identify what the participants felt about exercise.
Change in flow
时间窗: At baseline and at 6 months
Flow will be assessed using the Kurz Skala questionnaire. The Kurzskala consists 16 items which has to be answered on a seven-point rating scale from "does not apply" to "somewhat partially" to "applies".
Change in left atrial (LA) diameter
时间窗: At baseline and at 6 months
LA diameter (mm) will be measured using echocardiography
Change in Tricuspid Annular Plane Systolic Excursion of right ventricular functionality (TAPSE)
时间窗: At baseline and at 6 months
TAPSE (mm) will be measured using echocardiography
Change in depression
时间窗: At baseline and at 6 months
Depression will be assessed 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 left ventricular posterior wall end diastole (LVPWd)
时间窗: At baseline and at 6 months
LVPWd (mm) will be measured using echocardiography
Change in aortic valve pressure gradient (AoV PG)
时间窗: At baseline and at 6 months
AoV PG (mmHg) will be measured using echocardiography
Change in right ventricular end diastole (RVD)
时间窗: At baseline and at 6 months
RVD (mm) will be measured using echocardiography
Change in quality of life
时间窗: At baseline and at 6 months
Quality of life will be assessed using the physical and mental component subscales of the Greek 36-item Short-Form Healthy 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.
次要结局
- Change in blood lactate concentration (BLa)(At 6 months)
- Change in Delay onset muscle soreness (DOMS)(At baseline, at 6 months and 24 hours, 48 hours and 72 hours after)
- Body Height(At baseline)
- Electrocardiogram (ECG)(At baseline)
- Change in training internal load monitoring(At 6 months)
- Change in exercise - induced caloric expenditure(At 6 months)
- Change in training external load monitoring(At 6 months)
研究者
Ioannis G. Fatouros
Professor
University of Thessaly