The Influence of Football Training as a medicine_FIM_UTH
- Conditions
- Physical ActivityBody CompositionHealthySoccer Training
- Interventions
- Behavioral: FIM-1Behavioral: FIM-2Behavioral: ControlBehavioral: FIM-3
- Registration Number
- NCT05273203
- Lead Sponsor
- University of Thessaly
- Brief Summary
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.
- Detailed Description
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:
1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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:
1. Control group (no training)
2. FIM-1 (1 session/week)
3. FIM-2 (2 sessions/week)
4. FIM-3 (3 sessions/week)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FIM-1 FIM-1 Participated in a supervised 6 months football training program once per week and in measurements at baseline and at 6 months. FIM-2 FIM-2 Participated in a supervised 6 months football training program twice per week and in measurements at baseline and at 6 months. Control Control No intervention. Participated only in measurements at baseline and at 6 months. FIM-3 FIM-3 Participated in a supervised 6 months football training program thrice per week and in measurements at baseline and at 6 months.
- Primary Outcome Measures
Name Time Method Change in White blood cells (WBC) At baseline and at 6 months White blood cells will be measured using an automatic blood analyzer
Change in Body mass index At baseline and at 6 months Body mass index wil be calculated using the Quetelet's equation
Change in Body fat 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) 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) 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 At baseline and at 6 months Waist circumference (cm) will be measured using a Gullick II tape
Change in maximal strength (1RM) 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 At baseline and at 6 months Dietary intake (kcal) will be assessed using 7-day recalls
Change in maximal heart rate (MaxHR) At baseline and at 6 months MaxHR will be estimated using a low-risk submaximal treadmill walking test
Change in Interleukin 6 (IL-6) At baseline and at 6 months IL-6 (pg/ml) will be measured with commercially available kits
Change in oxidized glutathione (GSSG) 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) At baseline and at 6 months RBC concentration will be measured using an automatic blood analyzer
Change in Lymphocytes (LYM) At baseline and at 6 months LYM concentration will be measured using an automatic blood analyzer
Change in Hemoglobin A1c (HbA1c) At baseline and at 6 months HbA1c concentration will be measured with commercially available kits
Change in Hip circumference At baseline and at 6 months Hip circumference (cm) will be measured using a Gullick II tape
Change in maximal oxygen consumption (VO2max) 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 At baseline and at 6 months Daily physical activity will be assessed accelerometry device
Change in body mass density (BMD) 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 At baseline and at 6 months Knee, hip and ankle range of motion will be assessed using manual goniometer
Change in flexibility 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) At baseline and at 6 months IL-1b (pg/ml) will be measured with commercially available kits
Change in fasting blood glucose (FBG) At baseline and at 6 months FBG (mg/dL) will be measured with commercially available kits
Change in Uric acid (UA) At baseline and at 6 months UA concentration will be measured in plasma with commercially available kits
Change in isometric knee flexors peak torque 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 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) 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 fat mass 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 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 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) 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 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) At baseline and at 6 months CRP (mg/L) will be measured with commercially available kits
Change in Granulocyte (GRA) At baseline and at 6 months GRA concentration will be measured using an automatic blood analyzer
Change in Platelet (PLT) At baseline and at 6 months PLT concentration will be measured using an automatic blood analyzer
Change in monocytes (MON) At baseline and at 6 months PLT concentration will be measured using an automatic blood analyzer
Change in body mass At baseline and at 6 months Body mass (kg) wil be measured using a beam balance
Change in Waist-to-hip ratio 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 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 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 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) 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 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) 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) At baseline and at 6 months RHR will be measured by pulse palpation for 60 seconds
Change in functional capacity 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 At baseline and at 6 months Static balance will be assessed using the Sharened Romberg test
Change inTotal antioxidant capacity (TAC) At baseline and at 6 months TAC will be will be measured with commercially available kits
Change in Cortisol At baseline and at 6 months Cortisol (nmol/L) will be measured with commercially available kits
Change in insulin At baseline and at 6 months Insulin (mlU/L) will be measured with commercially available kits
Change in Catalase (CAT) activity 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 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 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) 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 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 Hematocrit (HCT) At baseline and at 6 months HCT concentration will be measured using an automatic blood analyzer
Change in Hemoglobin (HGB) At baseline and at 6 months HGB concentration will be measured using an automatic blood analyzer
Change in Cratine Kinase (CK) concentration At 6 months and 24 hours, 48 hours and 72 hours after CK concentration will be measured with commercially available kits
Change in concentric knee extensors peak torque 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) At baseline and at 6 months LVEDV (ml) will be measured using echocardiography
Change in interventicular septum and diastole (IVSd) At baseline and at 6 months IVSd will be measured using echocardiography
Change in isometric knee extensors peak torque 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) 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) At baseline and at 6 months LVSV (ml) will be measured using echocardiography
Change in left ventricular internal diameter and diastole (LVIDd) At baseline and at 6 months LVIDd (mm) will be measured using echocardiography
Change in pulmonary artery systolic pressure (PASP) At baseline and at 6 months PASP (mmHg) will be measured using echocardiography
Change vitality 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 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) At baseline and at 6 months IVSs will be measured using echocardiography
Change in left ventricular mass (LV mass) At baseline and at 6 months LV mass (g) will be measured using echocardiography
Change in aortic valve velocity (AoV Vel) At baseline and at 6 months AoV Vel (cm/s) will be measured using echocardiography
Change in left ventricular end-systolic volume (LVESV) At baseline and at 6 months LVESV (ml) will be measured using echocardiography
Change in left ventricular ejection fraction (LVEF) At baseline and at 6 months LVEF (%) will be measured using echocardiography
Change in left ventricular internal diameter and systole (LVIDs) At baseline and at 6 months LVIDs (mm) will be measured using echocardiography
Change in aortic root At baseline and at 6 months Aortic root (mm) will be measured using echocardiography
Change in right ventricular end diastole 1 (RVD1) 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 At baseline and at 6 months TV S' (mm) will be measured using echocardiography
Change in left ventricular fractional shortenning (FS) At baseline and at 6 months Fractional shortenning (%) will be measured using echocardiography
Change in left ventricular Global Longitudinal strain (GLS) At baseline and at 6 months GLS (%) will be measured using echocardiography
Change in pshycological well - being 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 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 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 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) At baseline and at 6 months TAPSE (mm) will be measured using echocardiography
Change in depression 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) At baseline and at 6 months LVPWd (mm) will be measured using echocardiography
Change in aortic valve pressure gradient (AoV PG) At baseline and at 6 months AoV PG (mmHg) will be measured using echocardiography
Change in right ventricular end diastole (RVD) At baseline and at 6 months RVD (mm) will be measured using echocardiography
Change in quality of life 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.
- Secondary Outcome Measures
Name Time Method Change in blood lactate concentration (BLa) At 6 months BLa (mmol/L) concentraton will be measured in a microphotometer with commerdially available kits. Blood samples will be collected pre, mid and post execise session (single bout) at 3 minute post exercise
Change in Delay onset muscle soreness (DOMS) At baseline, at 6 months and 24 hours, 48 hours and 72 hours after DOMS will be assessed using a scale consisiting of 9 multiple choices scored from 1 to 10
Body Height At baseline Height (cm) will be measured using stadiometer
Electrocardiogram (ECG) At baseline ECG will be recorded using the electrical heart signals by electrocardiogram device in order to examined the resting heart rate
Change in training internal load monitoring At 6 months Training internal load monitoring will be assessed using a pulse devises
Change in exercise - induced caloric expenditure At 6 months Measure using portable indirect calorimetry system. Οxygen consumption will be collected during exercise session
Change in training external load monitoring At 6 months Training external load monitoring will be assessed using GPS devise
Trial Locations
- Locations (1)
University o Thessaly, School of Physical Education and Sports Science
🇬🇷Tríkala, Greece