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Completed

NCT Number: NCT05273203

The Influence of Football Training as a medicine_FIM_UTH

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.

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Key information

Conditions

Soccer Training Behavior Body Composition Healthy Motor Activity Physical Activity

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University o Thessaly, School of Physical Education and Sports Science

Trikala, 42100, Greece

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Football training

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.

Other names: Football training

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.

Other names: Football training

Control

Behavioral

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

Primary outcomes

  1. Change in body mass

    Time frame: At baseline and at 6 months

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

  2. Change in Body mass index

    Time frame: At baseline and at 6 months

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

  3. Change in Waist circumference

    Time frame: At baseline and at 6 months

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

  4. Change in Hip circumference

    Time frame: At baseline and at 6 months

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

  5. Change in Waist-to-hip ratio

    Time frame: At baseline and at 6 months

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

  6. Change in Body fat

    Time frame: At baseline and at 6 months

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

  7. Change in fat mass

    Time frame: At baseline and at 6 months

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

  8. Change in fat-free mass

    Time frame: At baseline and at 6 months

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

  9. Change in resting metabolic rate (RMR)

    Time frame: 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

  10. Change in maximal strength (1RM)

    Time frame: 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

  11. Change in maximal oxygen consumption (VO2max)

    Time frame: At baseline and at 6 months

    VO2max (ml/kg/min) will be estimated using a low-risk submaximal treadmill walking test

  12. Change in dietary intake

    Time frame: At baseline and at 6 months

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

  13. Change in daily physical activity

    Time frame: At baseline and at 6 months

    Daily physical activity will be assessed accelerometry device

  14. Change in body mass content (BMC)

    Time frame: 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

  15. Change in body mass density (BMD)

    Time frame: 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

  16. Change in hip structural analysis

    Time frame: 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

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

    Time frame: At baseline and at 6 months

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

  18. Change in mean arterial pressure (MAP)

    Time frame: At baseline and at 6 months

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

  19. Change in resting heart rate (RHR)

    Time frame: At baseline and at 6 months

    RHR will be measured by pulse palpation for 60 seconds

  20. Change in maximal heart rate (MaxHR)

    Time frame: At baseline and at 6 months

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

  21. Change in functional capacity

    Time frame: 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).

  22. Change in static balance

    Time frame: At baseline and at 6 months

    Static balance will be assessed using the Sharened Romberg test

  23. Change in knee, hip and ankle range of motion

    Time frame: At baseline and at 6 months

    Knee, hip and ankle range of motion will be assessed using manual goniometer

  24. Change in functional mobility

    Time frame: At baseline and at 6 months

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

  25. Change in blood lipids

    Time frame: 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.

  26. Change in muscle endurance

    Time frame: 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.

  27. Change in flexibility

    Time frame: At baseline and at 6 months

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

  28. Change inTotal antioxidant capacity (TAC)

    Time frame: At baseline and at 6 months

    TAC will be will be measured with commercially available kits

  29. Change in Cortisol

    Time frame: At baseline and at 6 months

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

  30. Change in insulin

    Time frame: At baseline and at 6 months

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

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

    Time frame: 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)

  32. Change in Interleukin 1 beta (IL-1b)

    Time frame: At baseline and at 6 months

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

  33. Change in Interleukin 6 (IL-6)

    Time frame: At baseline and at 6 months

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

  34. Change in fasting blood glucose (FBG)

    Time frame: At baseline and at 6 months

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

  35. Change in Protein Carbonyls (PC) concentration

    Time frame: At baseline and at 6 months

    PC (mg) will be measured in red blood cells with commercially available kits

  36. Change in glutathione (GSH)

    Time frame: At baseline and at 6 months

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

  37. Change in oxidized glutathione (GSSG)

    Time frame: At baseline and at 6 months

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

  38. Change in Catalase (CAT) activity

    Time frame: At baseline and at 6 months

    CAT activity (units) will be measured in red blood cells with commercially available kits

  39. Change in C - reactive protein (CRP)

    Time frame: At baseline and at 6 months

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

  40. Change in Uric acid (UA)

    Time frame: At baseline and at 6 months

    UA concentration will be measured in plasma with commercially available kits

  41. Change in White blood cells (WBC)

    Time frame: At baseline and at 6 months

    White blood cells will be measured using an automatic blood analyzer

  42. Change in Granulocyte (GRA)

    Time frame: At baseline and at 6 months

    GRA concentration will be measured using an automatic blood analyzer

  43. Change in Hematocrit (HCT)

    Time frame: At baseline and at 6 months

    HCT concentration will be measured using an automatic blood analyzer

  44. Change in Hemoglobin (HGB)

    Time frame: At baseline and at 6 months

    HGB concentration will be measured using an automatic blood analyzer

  45. Change in red blood cells (RBC)

    Time frame: At baseline and at 6 months

    RBC concentration will be measured using an automatic blood analyzer

  46. Change in Lymphocytes (LYM)

    Time frame: At baseline and at 6 months

    LYM concentration will be measured using an automatic blood analyzer

  47. Change in Platelet (PLT)

    Time frame: At baseline and at 6 months

    PLT concentration will be measured using an automatic blood analyzer

  48. Change in monocytes (MON)

    Time frame: At baseline and at 6 months

    PLT concentration will be measured using an automatic blood analyzer

  49. Change in Cratine Kinase (CK) concentration

    Time frame: At 6 months and 24 hours, 48 hours and 72 hours after

    CK concentration will be measured with commercially available kits

  50. Change in Hemoglobin A1c (HbA1c)

    Time frame: At baseline and at 6 months

    HbA1c concentration will be measured with commercially available kits

  51. Change in isometric knee extensors peak torque

    Time frame: 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

  52. Change in isometric knee flexors peak torque

    Time frame: 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

  53. Change in eccentric knee extensors peak torque

    Time frame: At baseline and at 6 months

    eccentric knee extensors peak torque will be assessed on an isokinetic dynamometer

  54. Change in eccentric knee flexors peak torque

    Time frame: At baseline and at 6 months

    eccentric knee flexors peak torque will be assessed on an isokinetic dynamometer

  55. Change in concentric knee extensors peak torque

    Time frame: At baseline and at 6 months

    concentric knee extensors peak torque will be assessed on an isokinetic dynamometer

  56. Change in concentric knee flexors peak torque

    Time frame: At baseline and at 6 months

    concentric knee flexors peak torque will be assessed on an isokinetic dynamometer

  57. Change in counter movement jump height (CMJh)

    Time frame: 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

  58. Change in counter movement jump flight time (CMJf)

    Time frame: 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

  59. Change in counter movement jump power (CMJp)

    Time frame: 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

  60. Change in sprint time of 10m

    Time frame: 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

  61. Change in sprint time of 30m

    Time frame: 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

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

    Time frame: At baseline and at 6 months

    LVEDV (ml) will be measured using echocardiography

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

    Time frame: At baseline and at 6 months

    LVESV (ml) will be measured using echocardiography

  64. Change in left ventricular stroke volume (LVSV)

    Time frame: At baseline and at 6 months

    LVSV (ml) will be measured using echocardiography

  65. Change in interventicular septum and systole (IVSs)

    Time frame: At baseline and at 6 months

    IVSs will be measured using echocardiography

  66. Change in interventicular septum and diastole (IVSd)

    Time frame: At baseline and at 6 months

    IVSd will be measured using echocardiography

  67. Change in left ventricular ejection fraction (LVEF)

    Time frame: At baseline and at 6 months

    LVEF (%) will be measured using echocardiography

  68. Change in left ventricular internal diameter and diastole (LVIDd)

    Time frame: At baseline and at 6 months

    LVIDd (mm) will be measured using echocardiography

  69. Change in left ventricular internal diameter and systole (LVIDs)

    Time frame: At baseline and at 6 months

    LVIDs (mm) will be measured using echocardiography

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

    Time frame: At baseline and at 6 months

    LVPWd (mm) will be measured using echocardiography

  71. Change in left ventricular mass (LV mass)

    Time frame: At baseline and at 6 months

    LV mass (g) will be measured using echocardiography

  72. Change in left atrial (LA) diameter

    Time frame: At baseline and at 6 months

    LA diameter (mm) will be measured using echocardiography

  73. Change in aortic root

    Time frame: At baseline and at 6 months

    Aortic root (mm) will be measured using echocardiography

  74. Change in aortic valve velocity (AoV Vel)

    Time frame: At baseline and at 6 months

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

  75. Change in aortic valve pressure gradient (AoV PG)

    Time frame: At baseline and at 6 months

    AoV PG (mmHg) will be measured using echocardiography

  76. Change in right ventricular end diastole (RVD)

    Time frame: At baseline and at 6 months

    RVD (mm) will be measured using echocardiography

  77. Change in right ventricular end diastole 1 (RVD1)

    Time frame: At baseline and at 6 months

    RVD1 (mm) will be measured using echocardiography

  78. Change in Tricuspid Annular Plane Systolic Excursion of right ventricular functionality (TAPSE)

    Time frame: At baseline and at 6 months

    TAPSE (mm) will be measured using echocardiography

  79. Change in tricuspid annular systolic velocity (TV S') of Right ventricular functionality

    Time frame: At baseline and at 6 months

    TV S' (mm) will be measured using echocardiography

  80. Change in pulmonary artery systolic pressure (PASP)

    Time frame: At baseline and at 6 months

    PASP (mmHg) will be measured using echocardiography

  81. Change in left ventricular fractional shortenning (FS)

    Time frame: At baseline and at 6 months

    Fractional shortenning (%) will be measured using echocardiography

  82. Change in left ventricular Global Longitudinal strain (GLS)

    Time frame: At baseline and at 6 months

    GLS (%) will be measured using echocardiography

  83. Change in pshycological well - being

    Time frame: At baseline and at 6 months

    Psychological well - being will be assessed using The General Health Questionnaire (GHQ-12) via 12 items

  84. Change vitality

    Time frame: 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.

  85. Change in motivation

    Time frame: 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.

  86. Change in quality of life

    Time frame: 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.

  87. Change in flow

    Time frame: 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".

  88. Change in depression

    Time frame: 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.

Secondary outcomes

  1. Change in exercise - induced caloric expenditure

    Time frame: At 6 months

    Measure using portable indirect calorimetry system. Οxygen consumption will be collected during exercise session

  2. Change in blood lactate concentration (BLa)

    Time frame: 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

  3. Change in Delay onset muscle soreness (DOMS)

    Time frame: 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

  4. Change in training external load monitoring

    Time frame: At 6 months

    Training external load monitoring will be assessed using GPS devise

  5. Change in training internal load monitoring

    Time frame: At 6 months

    Training internal load monitoring will be assessed using a pulse devises

  6. Body Height

    Time frame: At baseline

    Height (cm) will be measured using stadiometer

  7. Electrocardiogram (ECG)

    Time frame: At baseline

    ECG will be recorded using the electrical heart signals by electrocardiogram device in order to examined the resting heart rate

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Acronym: FIM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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