Soccer TrainingFIMNCT05273203
The Influence of Football Training as a medicine_FIM_UTH
A study testing FIM-1, FIM-2 and FIM-3 in people with Soccer Training and Body Composition, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Soccer Training, Body Composition, Physical Activity
- What is being tested?
- FIM-1, FIM-2 and FIM-3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 31 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
University o Thessaly, School of Physical Education and Sports Science
Trikala, 42100
About this study
Official title: A Proposed Design for a Dose-Response Clinical Trial in High Risk Adults
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.
Read the 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:
- 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)
- Conditions
- Soccer Training, Body Composition, Physical Activity, Healthy
- Being tested
- FIM-1, FIM-2, FIM-3, Control
- Keywords
- Football, Health, Performance, Somatometric, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIM-1Behavioural
Also called Football training
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-2Behavioural
Also called Football training
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-3Behavioural
Also called Football training
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.
ControlBehavioural
No football training will be performed during 6 months period. Participation only in measurements at baseline and at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | No intervention. Participated only in measurements at baseline and at 6 months. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: FIM-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass
Body mass (kg) wil be measured using a beam balance
Measured: At baseline and at 6 months
Change in Body mass index
Body mass index wil be calculated using the Quetelet's equation
Measured: At baseline and at 6 months
Change in Waist circumference
Waist circumference (cm) will be measured using a Gullick II tape
Measured: At baseline and at 6 months
Change in Hip circumference
Hip circumference (cm) will be measured using a Gullick II tape
Measured: 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
Measured: At baseline and at 6 months
Change in Body fat
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and at 6 months
Change in dietary intake
Dietary intake (kcal) will be assessed using 7-day recalls
Measured: At baseline and at 6 months
Change in daily physical activity
Daily physical activity will be assessed accelerometry device
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and at 6 months
Change in resting heart rate (RHR)
RHR will be measured by pulse palpation for 60 seconds
Measured: At baseline and at 6 months
Change in maximal heart rate (MaxHR)
MaxHR will be estimated using a low-risk submaximal treadmill walking test
Measured: 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).
Measured: At baseline and at 6 months
Change in static balance
Static balance will be assessed using the Sharened Romberg test
Measured: 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
Measured: At baseline and at 6 months
Change in functional mobility
Functional mobility (sec) will be assessed using Gait speed test
Measured: 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.
Measured: 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.
Measured: At baseline and at 6 months
Change in flexibility
Flexibility (cm) will be assessed using the modified sit-and-reach test
Measured: At baseline and at 6 months
Change inTotal antioxidant capacity (TAC)
TAC will be will be measured with commercially available kits
Measured: At baseline and at 6 months
Change in Cortisol
Cortisol (nmol/L) will be measured with commercially available kits
Measured: At baseline and at 6 months
Change in insulin
Insulin (mlU/L) will be measured with commercially available kits
Measured: 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)
Measured: At baseline and at 6 months
Change in Interleukin 1 beta (IL-1b)
IL-1b (pg/ml) will be measured with commercially available kits
Measured: At baseline and at 6 months
Change in Interleukin 6 (IL-6)
IL-6 (pg/ml) will be measured with commercially available kits
Measured: At baseline and at 6 months
Change in fasting blood glucose (FBG)
FBG (mg/dL) will be measured with commercially available kits
Measured: 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
Measured: At baseline and at 6 months
Change in glutathione (GSH)
GSH (nmol/L) will be measured in red blood cells with commercially available kits
Measured: 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
Measured: 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
Measured: At baseline and at 6 months
Change in C - reactive protein (CRP)
CRP (mg/L) will be measured with commercially available kits
Measured: At baseline and at 6 months
Change in Uric acid (UA)
UA concentration will be measured in plasma with commercially available kits
Measured: At baseline and at 6 months
Change in White blood cells (WBC)
White blood cells will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Granulocyte (GRA)
GRA concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Hematocrit (HCT)
HCT concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Hemoglobin (HGB)
HGB concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in red blood cells (RBC)
RBC concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Lymphocytes (LYM)
LYM concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Platelet (PLT)
PLT concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in monocytes (MON)
PLT concentration will be measured using an automatic blood analyzer
Measured: At baseline and at 6 months
Change in Cratine Kinase (CK) concentration
CK concentration will be measured with commercially available kits
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and at 6 months
Change in left ventricular end-systolic volume (LVESV)
LVESV (ml) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular stroke volume (LVSV)
LVSV (ml) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in interventicular septum and systole (IVSs)
IVSs will be measured using echocardiography
Measured: At baseline and at 6 months
Change in interventicular septum and diastole (IVSd)
IVSd will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular ejection fraction (LVEF)
LVEF (%) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular internal diameter and diastole (LVIDd)
LVIDd (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular internal diameter and systole (LVIDs)
LVIDs (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular posterior wall end diastole (LVPWd)
LVPWd (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular mass (LV mass)
LV mass (g) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left atrial (LA) diameter
LA diameter (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in aortic root
Aortic root (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in aortic valve velocity (AoV Vel)
AoV Vel (cm/s) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in aortic valve pressure gradient (AoV PG)
AoV PG (mmHg) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in right ventricular end diastole (RVD)
RVD (mm) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in right ventricular end diastole 1 (RVD1)
RVD1 (mm) will be measured using echocardiography
Measured: 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
Measured: 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
Measured: At baseline and at 6 months
Change in pulmonary artery systolic pressure (PASP)
PASP (mmHg) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular fractional shortenning (FS)
Fractional shortenning (%) will be measured using echocardiography
Measured: At baseline and at 6 months
Change in left ventricular Global Longitudinal strain (GLS)
GLS (%) will be measured using echocardiography
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: At baseline and at 6 months
Secondary outcomes (7)
Change in exercise - induced caloric expenditure
Measure using portable indirect calorimetry system. Οxygen consumption will be collected during exercise session
Measured: At 6 months
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
Measured: At 6 months
Change in Delay onset muscle soreness (DOMS)
DOMS will be assessed using a scale consisiting of 9 multiple choices scored from 1 to 10
Measured: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Change in training external load monitoring
Training external load monitoring will be assessed using GPS devise
Measured: At 6 months
Change in training internal load monitoring
Training internal load monitoring will be assessed using a pulse devises
Measured: At 6 months
Body Height
Height (cm) will be measured using stadiometer
Measured: At baseline
Electrocardiogram (ECG)
ECG will be recorded using the electrical heart signals by electrocardiogram device in order to examined the resting heart rate
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start31 Jan 2022
- Primary completion25 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soccer TrainingStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- Ioannis G Fatouros, Prof, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273203
- Sponsor's protocol ID
- FIM_UTH
- Acronym
- FIM
- Status last verified
- Jun 2024
- First submitted
- 16 Feb 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Design for a Dose-Response Clinical Trial in High Risk Adults
- ClinicalTrials.gov ID
- NCT05273203
- Acronym / sponsor ID
- FIM / FIM_UTH
- Conditions
- Soccer Training, Body Composition, Physical Activity, Healthy
- Keywords
- Football, Health, Performance, Somatometric, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlNo intervention. Participated only in measurements at baseline and at 6 months. |
| FIM-1 | Experimental | Behavioral: FIM-1Participated in a supervised 6 months football training program once per week and in measurements at baseline and at 6 months. |
| FIM-2 | Experimental | Behavioral: FIM-2Participated in a supervised 6 months football training program twice per week and in measurements at baseline and at 6 months. |
| FIM-3 | Experimental | Behavioral: FIM-3Participated in a supervised 6 months football training program thrice per week and in measurements at baseline and at 6 months. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIM-1Also: Football trainingA 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. | Behavioural | FIM-1 |
| FIM-2Also: Football trainingA 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. | Behavioural | FIM-2 |
| FIM-3Also: Football trainingA 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. | Behavioural | FIM-3 |
| ControlNo football training will be performed during 6 months period. Participation only in measurements at baseline and at 6 months. | Behavioural | Control |
Primary outcome
Change in body mass
Time frame: At baseline and at 6 months
Body mass (kg) wil be measured using a beam balance
Change in Body mass index
Time frame: At baseline and at 6 months
Body mass index wil be calculated using the Quetelet's equation
Change in Waist circumference
Time frame: At baseline and at 6 months
Waist circumference (cm) will be measured using a Gullick II tape
Change in Hip circumference
Time frame: At baseline and at 6 months
Hip circumference (cm) will be measured using a Gullick II tape
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
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)
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)
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)
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
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
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
Change in dietary intake
Time frame: At baseline and at 6 months
Dietary intake (kcal) will be assessed using 7-day recalls
Change in daily physical activity
Time frame: At baseline and at 6 months
Daily physical activity will be assessed accelerometry device
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
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
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
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
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
Change in resting heart rate (RHR)
Time frame: At baseline and at 6 months
RHR will be measured by pulse palpation for 60 seconds
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
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).
Change in static balance
Time frame: At baseline and at 6 months
Static balance will be assessed using the Sharened Romberg test
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
Change in functional mobility
Time frame: At baseline and at 6 months
Functional mobility (sec) will be assessed using Gait speed test
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.
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.
Change in flexibility
Time frame: At baseline and at 6 months
Flexibility (cm) will be assessed using the modified sit-and-reach test
Change inTotal antioxidant capacity (TAC)
Time frame: At baseline and at 6 months
TAC will be will be measured with commercially available kits
Change in Cortisol
Time frame: At baseline and at 6 months
Cortisol (nmol/L) will be measured with commercially available kits
Change in insulin
Time frame: At baseline and at 6 months
Insulin (mlU/L) will be measured with commercially available kits
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)
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
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
Change in fasting blood glucose (FBG)
Time frame: At baseline and at 6 months
FBG (mg/dL) will be measured with commercially available kits
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
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
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
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
Change in C - reactive protein (CRP)
Time frame: At baseline and at 6 months
CRP (mg/L) will be measured with commercially available kits
Change in Uric acid (UA)
Time frame: At baseline and at 6 months
UA concentration will be measured in plasma with commercially available kits
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
Change in Granulocyte (GRA)
Time frame: At baseline and at 6 months
GRA concentration will be measured using an automatic blood analyzer
Change in Hematocrit (HCT)
Time frame: At baseline and at 6 months
HCT concentration will be measured using an automatic blood analyzer
Change in Hemoglobin (HGB)
Time frame: At baseline and at 6 months
HGB concentration will be measured using an automatic blood analyzer
Change in red blood cells (RBC)
Time frame: At baseline and at 6 months
RBC concentration will be measured using an automatic blood analyzer
Change in Lymphocytes (LYM)
Time frame: At baseline and at 6 months
LYM concentration will be measured using an automatic blood analyzer
Change in Platelet (PLT)
Time frame: At baseline and at 6 months
PLT concentration will be measured using an automatic blood analyzer
Change in monocytes (MON)
Time frame: At baseline and at 6 months
PLT concentration will be measured using an automatic blood analyzer
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
Change in Hemoglobin A1c (HbA1c)
Time frame: At baseline and at 6 months
HbA1c concentration will be measured with commercially available kits
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
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
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
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
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
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
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
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
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
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
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
Change in left ventricular end-diastolic volume (LVEDV)
Time frame: At baseline and at 6 months
LVEDV (ml) will be measured using echocardiography
Change in left ventricular end-systolic volume (LVESV)
Time frame: At baseline and at 6 months
LVESV (ml) will be measured using echocardiography
Change in left ventricular stroke volume (LVSV)
Time frame: At baseline and at 6 months
LVSV (ml) will be measured using echocardiography
Change in interventicular septum and systole (IVSs)
Time frame: At baseline and at 6 months
IVSs will be measured using echocardiography
Change in interventicular septum and diastole (IVSd)
Time frame: At baseline and at 6 months
IVSd will be measured using echocardiography
Change in left ventricular ejection fraction (LVEF)
Time frame: At baseline and at 6 months
LVEF (%) will be measured using echocardiography
Change in left ventricular internal diameter and diastole (LVIDd)
Time frame: At baseline and at 6 months
LVIDd (mm) will be measured using echocardiography
Change in left ventricular internal diameter and systole (LVIDs)
Time frame: At baseline and at 6 months
LVIDs (mm) will be measured using echocardiography
Change in left ventricular posterior wall end diastole (LVPWd)
Time frame: At baseline and at 6 months
LVPWd (mm) will be measured using echocardiography
Change in left ventricular mass (LV mass)
Time frame: At baseline and at 6 months
LV mass (g) will be measured using echocardiography
Change in left atrial (LA) diameter
Time frame: At baseline and at 6 months
LA diameter (mm) will be measured using echocardiography
Change in aortic root
Time frame: At baseline and at 6 months
Aortic root (mm) will be measured using echocardiography
Change in aortic valve velocity (AoV Vel)
Time frame: At baseline and at 6 months
AoV Vel (cm/s) will be measured using echocardiography
Change in aortic valve pressure gradient (AoV PG)
Time frame: At baseline and at 6 months
AoV PG (mmHg) will be measured using echocardiography
Change in right ventricular end diastole (RVD)
Time frame: At baseline and at 6 months
RVD (mm) will be measured using echocardiography
Change in right ventricular end diastole 1 (RVD1)
Time frame: At baseline and at 6 months
RVD1 (mm) will be measured using echocardiography
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
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
Change in pulmonary artery systolic pressure (PASP)
Time frame: At baseline and at 6 months
PASP (mmHg) will be measured using echocardiography
Change in left ventricular fractional shortenning (FS)
Time frame: At baseline and at 6 months
Fractional shortenning (%) will be measured using echocardiography
Change in left ventricular Global Longitudinal strain (GLS)
Time frame: At baseline and at 6 months
GLS (%) will be measured using echocardiography
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
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.
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.
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.
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".
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.
7 secondary outcomes
Change in exercise - induced caloric expenditure
Time frame: At 6 months
Change in blood lactate concentration (BLa)
Time frame: At 6 months
Change in Delay onset muscle soreness (DOMS)
Time frame: At baseline, at 6 months and 24 hours, 48 hours and 72 hours after
Change in training external load monitoring
Time frame: At 6 months
Change in training internal load monitoring
Time frame: At 6 months
Body Height
Time frame: At baseline
Electrocardiogram (ECG)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis G Fatouros, Prof study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIM-1, FIM-2 and FIM-3 in people with Soccer Training and Body Composition, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass (time frame: At baseline and at 6 months). The study lists 88 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.