The Influence of Football Training as a medicine_FIM_UTH

Healthy Clinical Trial

— FIM  

Official title:

A Proposed Design for a Dose-Response Clinical Trial in High Risk Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273203
• Other study ID #: FIM_UTH
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of Thessaly
• Contact: Ioannis G Fatouros, Prof
• Phone: +30 24310 47047
• Email: ifatouros[@].pe.uth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. The participants Vo2max <30ml/kg/min

2. age of 40-60 years

3. medical clearance for strenuous physical training

4. Free of chronic diseases

5. Free of musculoskeletal injury

6. waist circumference 80= cm for female and 94= cm for Male participants

7. no weight loss greater >10% of body mass before (=6 months) the study

8. 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

Exclusion Criteria:

Participants will be excluded from the study if they:

1. will not participate in =80% of total exercise sessions

2. will adhere to a nutritional intervention during the study

3. will modify the habitual physical activity levels during the study

4. Musculoskeletal injury

5. Chronic disease

Related Conditions & MeSH terms

• Body Composition
• Healthy
• Physical Activity
• Soccer Training

Intervention

Behavioral:
• FIM-1
A football group (12 participants/session) will participate in 60 minutes football training that will contain warm-up, football technical drills and exercises, fitness exercises and football game.
• FIM-2
A football group (12 participants/session) will participate in 60 minutes football training that will contain warm-up, football technical drills and exercises, fitness exercises and football game.
• FIM-3
A football group (12 participants/session) will participate in 60 minutes football training that will contain warm-up, football technical drills and exercises, fitness exercises and football game.
• Control
No football training will be performed during 6 months period. Participation only in measurements at baseline and at 6 months.

Locations

Country	Name	City	State
Greece	University o Thessaly, School of Physical Education and Sports Science	Tríkala

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass	Body mass (kg) wil be measured using a beam balance	At baseline and at 6 months
Primary	Change in Body mass index	Body mass index wil be calculated using the Quetelet's equation	At baseline and at 6 months
Primary	Change in Waist circumference	Waist circumference (cm) will be measured using a Gullick II tape	At baseline and at 6 months
Primary	Change in Hip circumference	Hip circumference (cm) will be measured using a Gullick II tape	At baseline and at 6 months
Primary	Change in Waist-to-hip ratio	Waist-to-hip ratio will be calculated by dividing the waist by the hip measurement	At baseline and at 6 months
Primary	Change in Body fat	Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)	At baseline and at 6 months
Primary	Change in fat mass	Body fat (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)	At baseline and at 6 months
Primary	Change in fat-free mass	Fat-free mass (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)	At baseline and at 6 months
Primary	Change in resting metabolic rate (RMR)	RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in maximal strength (1RM)	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	At baseline and at 6 months
Primary	Change in maximal oxygen consumption (VO2max)	VO2max (ml/kg/min) will be estimated using a low-risk submaximal treadmill walking test	At baseline and at 6 months
Primary	Change in dietary intake	Dietary intake (kcal) will be assessed using 7-day recalls	At baseline and at 6 months
Primary	Change in daily physical activity	Daily physical activity will be assessed accelerometry device	At baseline and at 6 months
Primary	Change in body mass content (BMC)	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	At baseline and at 6 months
Primary	Change in body mass density (BMD)	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	At baseline and at 6 months
Primary	Change in hip structural analysis	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	At baseline and at 6 months
Primary	Change in resting systolic (SBP) and diastolic (DBP) blood pressures	Resting SBP (mmHg) and DBP (mmHg) will be assessed by a manual sphygmomanometer	At baseline and at 6 months
Primary	Change in mean arterial pressure (MAP)	MAP (mmHg) will be calculated using the following equation : MAP = SBP + (DBP × DBP) / 3	At baseline and at 6 months
Primary	Change in resting heart rate (RHR)	RHR will be measured by pulse palpation for 60 seconds	At baseline and at 6 months
Primary	Change in maximal heart rate (MaxHR)	MaxHR will be estimated using a low-risk submaximal treadmill walking test	At baseline and at 6 months
Primary	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).	At baseline and at 6 months
Primary	Change in static balance	Static balance will be assessed using the Sharened Romberg test	At baseline and at 6 months
Primary	Change in knee, hip and ankle range of motion	Knee, hip and ankle range of motion will be assessed using manual goniometer	At baseline and at 6 months
Primary	Change in functional mobility	Functional mobility (sec) will be assessed using Gait speed test	At baseline and at 6 months
Primary	Change in blood lipids	Total serum cholesterol (mmol/L), triglycerides (mmol/L), low density lipoprotein (mmol/L) will be measured with commercially availlable kits.	At baseline and at 6 months
Primary	Change in muscle 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) respectively.	At baseline and at 6 months
Primary	Change in flexibility	Flexibility (cm) will be assessed using the modified sit-and-reach test	At baseline and at 6 months
Primary	Change inTotal antioxidant capacity (TAC)	TAC will be will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in Cortisol	Cortisol (nmol/L) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in insulin	Insulin (mlU/L) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in homeostatic model assessemnet for insulin resistance (HOMA-IR)	HOMA-IR will be measured with commercially available kits. ???? 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)	At baseline and at 6 months
Primary	Change in Interleukin 1 beta (IL-1b)	IL-1b (pg/ml) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in Interleukin 6 (IL-6)	IL-6 (pg/ml) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in fasting blood glucose (FBG)	FBG (mg/dL) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in Protein Carbonyls (PC) concentration	PC (mg) will be measured in red blood cells with commercially available kits	At baseline and at 6 months
Primary	Change in glutathione (GSH)	GSH (nmol/L) will be measured in red blood cells with commercially available kits	At baseline and at 6 months
Primary	Change in oxidized glutathione (GSSG)	GSSG (nmol/L) will be measured in red blood cells with commercially available kits	At baseline and at 6 months
Primary	Change in Catalase (CAT) activity	CAT activity (units) will be measured in red blood cells with commercially available kits	At baseline and at 6 months
Primary	Change in C - reactive protein (CRP)	CRP (mg/L) will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in Uric acid (UA)	UA concentration will be measured in plasma with commercially available kits	At baseline and at 6 months
Primary	Change in White blood cells (WBC)	White blood cells will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Granulocyte (GRA)	GRA concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Hematocrit (HCT)	HCT concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Hemoglobin (HGB)	HGB concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in red blood cells (RBC)	RBC concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Lymphocytes (LYM)	LYM concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Platelet (PLT)	PLT concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in monocytes (MON)	PLT concentration will be measured using an automatic blood analyzer	At baseline and at 6 months
Primary	Change in Cratine Kinase (CK) concentration	CK concentration will be measured with commercially available kits	At 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in Hemoglobin A1c (HbA1c)	HbA1c concentration will be measured with commercially available kits	At baseline and at 6 months
Primary	Change in isometric knee extensors peak torque	isometric knee extensors peak torque will be assessed on an isokinetic dynamometer	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in isometric knee flexors peak torque	isometric knee flexors peak torque will be assessed on an isokinetic dynamometer	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in eccentric knee extensors peak torque	eccentric knee extensors peak torque will be assessed on an isokinetic dynamometer	At baseline and at 6 months
Primary	Change in eccentric knee flexors peak torque	eccentric knee flexors peak torque will be assessed on an isokinetic dynamometer	At baseline and at 6 months
Primary	Change in concentric knee extensors peak torque	concentric knee extensors peak torque will be assessed on an isokinetic dynamometer	At baseline and at 6 months
Primary	Change in concentric knee flexors peak torque	concentric knee flexors peak torque will be assessed on an isokinetic dynamometer	At baseline and at 6 months
Primary	Change in counter movement jump height (CMJh)	CMJh (cm) will be assessed using a force platform with each foot parallel on platform	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in counter movement jump flight time (CMJf)	CMJf (ms) will be assessed using a force platform with each foot parallel on platform	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in counter movement jump power (CMJp)	CMJp (w/kg) will be assessed using a force platform with each foot parallel on platform	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in sprint time of 10m	Sprint time (sec) will be assessed over a 10 m distance ising light cells	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in sprint time of 30m	Sprint time (sec) will be assessed over a 30 m distance ising light cells	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Primary	Change in left ventricular end-diastolic volume (LVEDV)	LVEDV (ml) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular end-systolic volume (LVESV)	LVESV (ml) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular stroke volume (LVSV)	LVSV (ml) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in interventicular septum and systole (IVSs)	IVSs will be measured using echocardiography	At baseline and at 6 months
Primary	Change in interventicular septum and diastole (IVSd)	IVSd will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular ejection fraction (LVEF)	LVEF (%) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular internal diameter and diastole (LVIDd)	LVIDd (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular internal diameter and systole (LVIDs)	LVIDs (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular posterior wall end diastole (LVPWd)	LVPWd (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular mass (LV mass)	LV mass (g) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left atrial (LA) diameter	LA diameter (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in aortic root	Aortic root (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in aortic valve velocity (AoV Vel)	AoV Vel (cm/s) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in aortic valve pressure gradient (AoV PG)	AoV PG (mmHg) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in right ventricular end diastole (RVD)	RVD (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in right ventricular end diastole 1 (RVD1)	RVD1 (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in Tricuspid Annular Plane Systolic Excursion of right ventricular functionality (TAPSE)	TAPSE (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in tricuspid annular systolic velocity (TV S') of Right ventricular functionality	TV S' (mm) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in pulmonary artery systolic pressure (PASP)	PASP (mmHg) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular fractional shortenning (FS)	Fractional shortenning (%) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in left ventricular Global Longitudinal strain (GLS)	GLS (%) will be measured using echocardiography	At baseline and at 6 months
Primary	Change in pshycological well - being	Psychological well - being will be assessed using The General Health Questionnaire (GHQ-12) via 12 items	At baseline and at 6 months
Primary	Change vitality	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.	At baseline and at 6 months
Primary	Change in motivation	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.	At baseline and at 6 months
Primary	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 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.	At baseline and at 6 months
Primary	Change in flow	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".	At baseline and at 6 months
Primary	Change in depression	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.	At baseline and at 6 months
Secondary	Change in exercise - induced caloric expenditure	Measure using portable indirect calorimetry system. ?xygen consumption will be collected during exercise session	At 6 months
Secondary	Change in blood lactate concentration (BLa)	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	At 6 months
Secondary	Change in Delay onset muscle soreness (DOMS)	DOMS will be assessed using a scale consisiting of 9 multiple choices scored from 1 to 10	At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Secondary	Change in training external load monitoring	Training external load monitoring will be assessed using GPS devise	At 6 months
Secondary	Change in training internal load monitoring	Training internal load monitoring will be assessed using a pulse devises	At 6 months
Secondary	Body Height	Height (cm) will be measured using stadiometer	At baseline
Secondary	Electrocardiogram (ECG)	ECG will be recorded using the electrical heart signals by electrocardiogram device in order to examined the resting heart rate	At baseline