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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06260215
Other study ID # FFH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date March 9, 2024

Study information

Verified date February 2024
Source University of Thessaly
Contact Ioannis G Fatouros, Prof
Phone +30 24310 47047
Email ifatouros@.pe.uth.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session [A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training.


Description:

Eleven male middle-aged participants will be included in this study. Participants will be initially informed about the main goals of study as well as the associated risks and benefits and then will provide their signed consent form. At baseline, they will undergo assessment of their anthropometrics (body mass, height, BMI, WHR), body compotition (using DXA), physical contition level (peak oxygen consumption, VO2peak), haemodynamic profile (diastolic and diastolic blood pressure) and daily dietary intake.Thereafter, they will participate in two experimental trials (Control trial and Soccer trial) in a randomized, crossover, repeated measure design: 1) ST (Soccer Trial): Participants in this trial will perform a soccer training session (60 min) consisted of warm-up, technical exercises and small-sided game, CT (Control Trial): Participants in this trial will only execute the evaluations daily in the dependent variables (they will not receive any intervention). Before each trial, the participants will provide a resting blood sample (for the determination of white blood cells, granulocyte cells, monocyte cells, lymphocyte cells, Hemeatocrit, Hemoglobin, red blood cells and platelets, total antioxidant capacity, glutathione and creatine kinase activity) and undergo assessments of their delay onset muscle soreness (DOMS), maximal voluntary isometric contraction (MVIC) of knee extensors and flexors (by isokinetic dynamometer), height and power of countermovement jump (CMJ-using force platform), 10m and 30m sprint time (will be evaluated using light cells). A 7-day wash-out period will apllied between ST and CT. The blood sample will be collected before and 24, 48 and 72 hours post-taining. Also, the evaluation of DOMS, MVIC, sprinting performance, power and jump height (by CMJ) will be evaluated before and 24, 48, 72 and 96 hours post training.


Recruitment information / eligibility

Status Recruiting
Enrollment 11
Est. completion date March 9, 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Free of musculoskeletal injuries - No use of ergogenic supplements or medication - Free of chronic diseases - age of 40-60 years Exclusion Criteria: - Musculoskeletal injury - Use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ST
Participants will perform a soccer training (ST) session for 60 minutes. The training will include the warm-up, soccer technical exercises and a small-side game

Locations

Country Name City State
Greece University o Thessaly, School of Physical Education and Sports Science Tríkala

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in White blood cell count White blood cell count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Granulocyte cell count Change in White blood cell count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Platelets cell count Platelets cell count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Monocyte cell count Monocytes cell count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Lymphocyte cell count Lymphocyte cell count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in percentage of Hematocrit level The percentage of Hematocrit level will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change Red blood cells count Red blood cells count will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Hemoglobin level Hemoglobin level will be measured using an automatic blood analyzer At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Creatine kinase activity Creatine kinase activity will be measured in plasma At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Total antioxidant capacity Total antioxidant capacity will be measured in plasma At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in Glutathione concentration in blood Glutathione concentration will be measured in red blood cells At baseline, at 24, 48 and 72 hours after soccer training
Primary Change in countermovement jump height countermovement jump height will be measured using a force platform At baseline, at 24, 48, 72 and 96 hours after soccer training
Primary Change in Peak power during coutermovement jump test The peak power will be measured using a force platform At baseline, at 24, 48, 72 and 96 hours after soccer training
Primary Change in isometric peak torque of knee extensors and flexors Isometric peak torque will be assessed on an isokinetic dynamometer At baseline, at 24, 48, 72 and 96 hours after soccer training
Primary Change in sprint time of 10 m 10m sprint time will be assessed using light cells At baseline, at 24, 48, 72 and 96 hours after soccer training
Primary Change in sprint time of 30 m 30m sprint time will be assessed using light cells At baseline, at 24, 48, 72 and 96 hours after soccer training
Primary Change in delayed onset of muscle soreness Muscle soreness will be assessed by palpation of muscle belly and the distal region At baseline, at 24, 48, 72 and 96 hours after soccer training
Secondary Dietary intake Dietary intake will be assesed over a 7-day period using diet recalls At baseline
Secondary Peak Maximal oxygen consumption (Peak VO2) Peak VO2 will be estimated by open circuit spirometry via breath by breath method At baseline
Secondary Body Mass Body Mass will be measured on a beam balance with stadiometer At baseline
Secondary Body Height Body Height will be measured on a beam balance with stadiometer At baseline
Secondary Body Fat Body Fat will be measured by using Dual-emission X-ray absorptiometry At baseline
Secondary Lean body mass Lean body mass will be measured by using Dual-emission X-ray absorptiometry At baseline
Secondary Bone mass density Bone mass density will be measured by using Dual-emission X-ray absorptiometry At baseline
Secondary Bone mass content Bone mass content will be measured by using Dual-emission X-ray absorptiometry At baseline
Secondary Field activity during the soccer training The field activity will be continuously monitored during the soccer training using global positioning system (GPS) During the 60 minutes soccer training (ST) session (72 hours after baseline measurements)
Secondary Heart rate during the soccer training Heart rate will be continuously monitored during the soccer training using heart rate monitors During the 60 minutes soccer training (ST) session (72 hours after baseline measurements)
Secondary Systolic Blood Pressure Systolic Blood Pressure will be examined using sphygmomanometer At baseline
Secondary Dystolic Blood Pressure Dystolic Blood Pressure will be examined using sphygmomanometer At baseline
Secondary Rest Heart Rate The rest heart rate will be estimated using a heart rate monitor At baseline
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