The Influence of Football Training as a medicine_FIM_UTH

NCT05273203 | Completed

• 1 other identifier: FIM_UTH
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Soccer Training; Body Composition; Physical Activity; Healthy

Keywords

Football; Health; Performance; Somatometric; Quality of life

Outcome Measures

Primary Outcomes (88)

• Change in body mass

  Body mass (kg) wil be measured using a beam balance

  At baseline and at 6 months

• Change in Body mass index

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

  At baseline and at 6 months

• Change in Waist circumference

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

  At baseline and at 6 months

• Change in Hip circumference

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

  At baseline and at 6 months

• 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

• Change in Body fat

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

  At baseline and at 6 months

• 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

• 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

• 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

• 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

• 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

• Change in dietary intake

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

  At baseline and at 6 months

• Change in daily physical activity

  Daily physical activity will be assessed accelerometry device

  At baseline and at 6 months

• 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

• 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

• 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

• 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

• 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

• Change in resting heart rate (RHR)

  RHR will be measured by pulse palpation for 60 seconds

  At baseline and at 6 months

• Change in maximal heart rate (MaxHR)

  MaxHR will be estimated using a low-risk submaximal treadmill walking test

  At baseline and at 6 months

• 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

• Change in static balance

  Static balance will be assessed using the Sharened Romberg test

  At baseline and at 6 months

• 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

• Change in functional mobility

  Functional mobility (sec) will be assessed using Gait speed test

  At baseline and at 6 months

• 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

• 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

• Change in flexibility

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

  At baseline and at 6 months

• Change inTotal antioxidant capacity (TAC)

  TAC will be will be measured with commercially available kits

  At baseline and at 6 months

• Change in Cortisol

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

  At baseline and at 6 months

• Change in insulin

  Insulin (mlU/L) will be measured with commercially available kits

  At baseline and at 6 months

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

  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)

  At baseline and at 6 months

• Change in Interleukin 1 beta (IL-1b)

  IL-1b (pg/ml) will be measured with commercially available kits

  At baseline and at 6 months

• Change in Interleukin 6 (IL-6)

  IL-6 (pg/ml) will be measured with commercially available kits

  At baseline and at 6 months

• Change in fasting blood glucose (FBG)

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

  At baseline and at 6 months

• 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

• Change in glutathione (GSH)

  GSH (nmol/L) will be measured in red blood cells with commercially available kits

  At baseline and at 6 months

• 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

• 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

• Change in C - reactive protein (CRP)

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

  At baseline and at 6 months

• Change in Uric acid (UA)

  UA concentration will be measured in plasma with commercially available kits

  At baseline and at 6 months

• Change in White blood cells (WBC)

  White blood cells will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in Granulocyte (GRA)

  GRA concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in Hematocrit (HCT)

  HCT concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in Hemoglobin (HGB)

  HGB concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in red blood cells (RBC)

  RBC concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in Lymphocytes (LYM)

  LYM concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in Platelet (PLT)

  PLT concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• Change in monocytes (MON)

  PLT concentration will be measured using an automatic blood analyzer

  At baseline and at 6 months

• 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

• Change in Hemoglobin A1c (HbA1c)

  HbA1c concentration will be measured with commercially available kits

  At baseline and at 6 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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

  LVEDV (ml) will be measured using echocardiography

  At baseline and at 6 months

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

  LVESV (ml) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular stroke volume (LVSV)

  LVSV (ml) will be measured using echocardiography

  At baseline and at 6 months

• Change in interventicular septum and systole (IVSs)

  IVSs will be measured using echocardiography

  At baseline and at 6 months

• Change in interventicular septum and diastole (IVSd)

  IVSd will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular ejection fraction (LVEF)

  LVEF (%) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular internal diameter and diastole (LVIDd)

  LVIDd (mm) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular internal diameter and systole (LVIDs)

  LVIDs (mm) will be measured using echocardiography

  At baseline and at 6 months

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

  LVPWd (mm) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular mass (LV mass)

  LV mass (g) will be measured using echocardiography

  At baseline and at 6 months

• Change in left atrial (LA) diameter

  LA diameter (mm) will be measured using echocardiography

  At baseline and at 6 months

• Change in aortic root

  Aortic root (mm) will be measured using echocardiography

  At baseline and at 6 months

• Change in aortic valve velocity (AoV Vel)

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

  At baseline and at 6 months

• Change in aortic valve pressure gradient (AoV PG)

  AoV PG (mmHg) will be measured using echocardiography

  At baseline and at 6 months

• Change in right ventricular end diastole (RVD)

  RVD (mm) will be measured using echocardiography

  At baseline and at 6 months

• Change in right ventricular end diastole 1 (RVD1)

  RVD1 (mm) will be measured using echocardiography

  At baseline and at 6 months

• 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

• 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

• Change in pulmonary artery systolic pressure (PASP)

  PASP (mmHg) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular fractional shortenning (FS)

  Fractional shortenning (%) will be measured using echocardiography

  At baseline and at 6 months

• Change in left ventricular Global Longitudinal strain (GLS)

  GLS (%) will be measured using echocardiography

  At baseline and at 6 months

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Change in exercise - induced caloric expenditure

  At 6 months

• 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

• Change in training external load monitoring

  At 6 months

• Change in training internal load monitoring

  At 6 months

Study Arms (4)

Control

EXPERIMENTAL

No intervention. Participated only in measurements at baseline and at 6 months.

Behavioral: Control

FIM-1

EXPERIMENTAL

Participated in a supervised 6 months football training program once per week and in measurements at baseline and at 6 months.

Behavioral: FIM-1

FIM-2

EXPERIMENTAL

Participated in a supervised 6 months football training program twice per week and in measurements at baseline and at 6 months.

Behavioral: FIM-2

FIM-3

EXPERIMENTAL

Participated in a supervised 6 months football training program thrice per week and in measurements at baseline and at 6 months.

Behavioral: FIM-3

Interventions

FIM-1 BEHAVIORAL

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.

Also known as: Football training

FIM-1

FIM-2 BEHAVIORAL

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.

Also known as: Football training

FIM-2

FIM-3 BEHAVIORAL

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.

Also known as: Football training

FIM-3

Control BEHAVIORAL

No football training will be performed during 6 months period. Participation only in measurements at baseline and at 6 months.

Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University o Thessaly, School of Physical Education and Sports Science

Trikala, 42100, Greece

Location

MeSH Terms

Conditions

Motor Activity

Interventions

fim 1; fim 2

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ioannis G Fatouros, Prof

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 10, 2022
• Study Start: January 31, 2022
• Primary Completion: August 25, 2023
• Study Completion: December 31, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

GR (1)