The Influence of Football Training as a medicine_FIM_UTH

NCT ID: NCT05273203

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-12-31

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)

Conditions

Soccer Training; Body Composition; Physical Activity; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: EXPERIMENTAL

Control

Intervention Type: BEHAVIORAL

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

FIM-1

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

Group Type: EXPERIMENTAL

FIM-1

Intervention Type: 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.

FIM-2

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

Group Type: EXPERIMENTAL

FIM-2

Intervention Type: 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.

FIM-3

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

Group Type: EXPERIMENTAL

FIM-3

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Football training; Football training; Football training

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Ioannis G. Fatouros

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioannis G Fatouros, Prof

Role: STUDY_DIRECTOR

University of Thessaly

Locations

University o Thessaly, School of Physical Education and Sports Science

Trikala, , Greece

Countries

Greece

Other Identifiers

FIM_UTH

Identifier Type: -

Identifier Source: org_study_id