Clinical trial NCT05273203: The Influence of Football Training as a medicine_FIM_UTH
Official title: A Proposed Design for a Dose-Response Clinical Trial in High Risk Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soccer Training
Body Composition
Physical Activity
Healthy
Keywords: Football
Health
Performance
Somatometric
Quality of life
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass
timeFrame: At baseline and at 6 months
measure: Change in Body mass index
timeFrame: At baseline and at 6 months
measure: Change in Waist circumference
timeFrame: At baseline and at 6 months
measure: Change in Hip circumference
timeFrame: At baseline and at 6 months
measure: Change in Waist-to-hip ratio
timeFrame: At baseline and at 6 months
measure: Change in Body fat
timeFrame: At baseline and at 6 months
measure: Change in fat mass
timeFrame: At baseline and at 6 months
measure: Change in fat-free mass
timeFrame: At baseline and at 6 months
measure: Change in resting metabolic rate (RMR)
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in maximal strength (1RM)
timeFrame: At baseline and at 6 months
measure: Change in maximal oxygen consumption (VO2max)
timeFrame: At baseline and at 6 months
measure: Change in dietary intake
timeFrame: At baseline and at 6 months
measure: Change in daily physical activity
timeFrame: At baseline and at 6 months
measure: Change in body mass content (BMC)
timeFrame: At baseline and at 6 months
measure: Change in body mass density (BMD)
timeFrame: At baseline and at 6 months
measure: Change in hip structural analysis
timeFrame: At baseline and at 6 months
measure: Change in resting systolic (SBP) and diastolic (DBP) blood pressures
timeFrame: At baseline and at 6 months
measure: Change in mean arterial pressure (MAP)
timeFrame: At baseline and at 6 months
measure: Change in resting heart rate (RHR)
timeFrame: At baseline and at 6 months
measure: Change in maximal heart rate (MaxHR)
timeFrame: At baseline and at 6 months
measure: Change in functional capacity
timeFrame: At baseline and at 6 months
measure: Change in static balance
timeFrame: At baseline and at 6 months
measure: Change in knee, hip and ankle range of motion
timeFrame: At baseline and at 6 months
measure: Change in functional mobility
timeFrame: At baseline and at 6 months
measure: Change in blood lipids
timeFrame: At baseline and at 6 months
measure: Change in muscle endurance
timeFrame: At baseline and at 6 months
measure: Change in flexibility
timeFrame: At baseline and at 6 months
measure: Change inTotal antioxidant capacity (TAC)
timeFrame: At baseline and at 6 months
measure: Change in Cortisol
timeFrame: At baseline and at 6 months
measure: Change in insulin
timeFrame: At baseline and at 6 months
measure: Change in homeostatic model assessemnet for insulin resistance (HOMA-IR)
timeFrame: At baseline and at 6 months
measure: Change in Interleukin 1 beta (IL-1b)
timeFrame: At baseline and at 6 months
measure: Change in Interleukin 6 (IL-6)
timeFrame: At baseline and at 6 months
measure: Change in fasting blood glucose (FBG)
timeFrame: At baseline and at 6 months
measure: Change in Protein Carbonyls (PC) concentration
timeFrame: At baseline and at 6 months
measure: Change in glutathione (GSH)
timeFrame: At baseline and at 6 months
measure: Change in oxidized glutathione (GSSG)
timeFrame: At baseline and at 6 months
measure: Change in Catalase (CAT) activity
timeFrame: At baseline and at 6 months
measure: Change in C - reactive protein (CRP)
timeFrame: At baseline and at 6 months
measure: Change in Uric acid (UA)
timeFrame: At baseline and at 6 months
measure: Change in White blood cells (WBC)
timeFrame: At baseline and at 6 months
measure: Change in Granulocyte (GRA)
timeFrame: At baseline and at 6 months
measure: Change in Hematocrit (HCT)
timeFrame: At baseline and at 6 months
measure: Change in Hemoglobin (HGB)
timeFrame: At baseline and at 6 months
measure: Change in red blood cells (RBC)
timeFrame: At baseline and at 6 months
measure: Change in Lymphocytes (LYM)
timeFrame: At baseline and at 6 months
measure: Change in Platelet (PLT)
timeFrame: At baseline and at 6 months
measure: Change in monocytes (MON)
timeFrame: At baseline and at 6 months
measure: Change in Cratine Kinase (CK) concentration
timeFrame: At 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: At baseline and at 6 months
measure: Change in isometric knee extensors peak torque
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in isometric knee flexors peak torque
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in eccentric knee extensors peak torque
timeFrame: At baseline and at 6 months
measure: Change in eccentric knee flexors peak torque
timeFrame: At baseline and at 6 months
measure: Change in concentric knee extensors peak torque
timeFrame: At baseline and at 6 months
measure: Change in concentric knee flexors peak torque
timeFrame: At baseline and at 6 months
measure: Change in counter movement jump height (CMJh)
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in counter movement jump flight time (CMJf)
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in counter movement jump power (CMJp)
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in sprint time of 10m
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in sprint time of 30m
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in left ventricular end-diastolic volume (LVEDV)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular end-systolic volume (LVESV)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular stroke volume (LVSV)
timeFrame: At baseline and at 6 months
measure: Change in interventicular septum and systole (IVSs)
timeFrame: At baseline and at 6 months
measure: Change in interventicular septum and diastole (IVSd)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular internal diameter and diastole (LVIDd)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular internal diameter and systole (LVIDs)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular posterior wall end diastole (LVPWd)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular mass (LV mass)
timeFrame: At baseline and at 6 months
measure: Change in left atrial (LA) diameter
timeFrame: At baseline and at 6 months
measure: Change in aortic root
timeFrame: At baseline and at 6 months
measure: Change in aortic valve velocity (AoV Vel)
timeFrame: At baseline and at 6 months
measure: Change in aortic valve pressure gradient (AoV PG)
timeFrame: At baseline and at 6 months
measure: Change in right ventricular end diastole (RVD)
timeFrame: At baseline and at 6 months
measure: Change in right ventricular end diastole 1 (RVD1)
timeFrame: At baseline and at 6 months
measure: Change in Tricuspid Annular Plane Systolic Excursion of right ventricular functionality (TAPSE)
timeFrame: At baseline and at 6 months
measure: Change in tricuspid annular systolic velocity (TV S') of Right ventricular functionality
timeFrame: At baseline and at 6 months
measure: Change in pulmonary artery systolic pressure (PASP)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular fractional shortenning (FS)
timeFrame: At baseline and at 6 months
measure: Change in left ventricular Global Longitudinal strain (GLS)
timeFrame: At baseline and at 6 months
measure: Change in pshycological well - being
timeFrame: At baseline and at 6 months
measure: Change vitality
timeFrame: At baseline and at 6 months
measure: Change in motivation
timeFrame: At baseline and at 6 months
measure: Change in quality of life
timeFrame: At baseline and at 6 months
measure: Change in flow
timeFrame: At baseline and at 6 months
measure: Change in depression
timeFrame: At baseline and at 6 months
Secondary outcomes:
measure: Change in exercise - induced caloric expenditure
timeFrame: At 6 months
measure: Change in blood lactate concentration (BLa)
timeFrame: At 6 months
measure: Change in Delay onset muscle soreness (DOMS)
timeFrame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
measure: Change in training external load monitoring
timeFrame: At 6 months
measure: Change in training internal load monitoring
timeFrame: At 6 months
measure: Body Height
timeFrame: At baseline
measure: Electrocardiogram (ECG)
timeFrame: At baseline
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: University o Thessaly, School of Physical Education and Sports Science
Study officials:
affiliation: University of Thessaly
name: Ioannis G Fatouros, Prof
role: STUDY_DIRECTOR
References: