| CTRI Number |
CTRI/2025/08/093534 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Male volunteers will be given sports training, then training adaptations will be measured.] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of Training Load and Nutrition on Training Associated Adaptations in Male Football Players. |
|
Scientific Title of Study
|
Study the Effects of Training on Body Composition, Physical Fitness, Physiological and Biochemical Variables of Football Players: Importance of Nutrition and Training Load |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAYAN JYOTI BERA |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
Midnapore College (Autonomous) |
| Address |
Department of Physiology, Midnapore College (Autonomous), Raja Bazar Main Road, Midnapore, West Bengal, India, 721101.
Medinipur
WEST BENGAL
721101
India |
| Phone |
7001938241 |
| Fax |
|
| Email |
sayanjyotibera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indranil Manna |
| Designation |
Associate Professor |
| Affiliation |
Midnapore College (Autonomous) |
| Address |
Department of Physiology, Midnapore College (Autonomous), Raja Bazar Main Road, Midnapore, West Bengal, India, 721101.
Medinipur
WEST BENGAL
7221101
India |
| Phone |
7908839517 |
| Fax |
|
| Email |
indranil.manna@midnaporecollege.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indranil Manna |
| Designation |
Associate Professor |
| Affiliation |
Midnapore College (Autonomous) |
| Address |
Department of Physiology, Midnapore College (Autonomous), Raja Bazar Main Road, Midnapore, West Bengal, India, 721101.
Medinipur
WEST BENGAL
7221101
India |
| Phone |
7908839517 |
| Fax |
|
| Email |
indranil.manna@midnaporecollege.ac.in |
|
|
Source of Monetary or Material Support
|
| Midnapore College (Autonomous), Raja Bazar Main Road, Midnapore, West Midnapore, West Bengal, India, Pin-721101. |
|
|
Primary Sponsor
|
| Name |
Midnapore College (Autonomous) |
| Address |
Department of Physiology, Midnapore College (Autonomous), Raja Bazar Main Road, Midnapore, West Bengal, India, 721101 |
| Type of Sponsor |
Other [Government Affiliated Autonomous College.] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SAYAN JYOTI BERA |
Midnapore College (Autonomous) |
Department of Physiology, Midnapore College (Autonomous), Raja Bazar Main Rd, Midnapore, West Bengal, India, Pin- 721101.
Medinipur
WEST BENGAL |
7001938241
sayanjyotibera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES), MIDNAPORE COLLEGE (AUTONOMOUS) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male Football players within the age of 12-18 years who are free from history of recent disease or illness will be considered eligible in this study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Impact of Training on Male Football Players |
Impact of Training on Morphological, Physical fitness, Physiological and Biochemical Variables of Male Football Players. For first phase of study (Existing Training Schedule): Baseline at 0 week, Mid Intervention at 8 weeks and Post Intervention at 12 weeks. For second phase of study (Modified Training Schedule): Baseline at 0 week, Mid Intervention at 8 weeks and Post Intervention at 12 weeks. Total duration of intervention is 24 weeks. |
| Comparator Agent |
Structured Sports Training, Training Load. |
Only the male soccer players of experimental group will undergo training. No training will be given to control group. Then the performance change in experimental group will be compared with control group. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion Criteria for Experimental Group: Football players from the age of 12-18 years who are playing football for at least two years and participates in different competitions will be considered eligible for this study. Football players free from history of recent disease or illness will be included in the study. The decision will be based on the medical examination performed by physicians.
Inclusion Criteria for Control Group: Sedentary participants from the age of 12-18 years will be considered eligible for this study. Volunteers does not participate in any sports activities, free from history of recent disease and illness, able to perform prescribed tests will be included in the study. The decision will be based on the medical examination performed by Physicians.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for Experimental Group: Participants will be excluded if they are unwilling to take part in the study, had a history of disease and illness for at least 03 months prior to the commencement of the study. Other exclusion criteria include any medical or surgical conditions which may hinder physical performance e.g. evidence of inflammatory joint disease and lower limb pathology, recent fracture of the spine, past history of operative intervention for lower back problems, metastatic diseases, anxiety neurosis and depression.
Exclusion Criteria for Control Group: Participants will be excluded if they are unwilling to take part in the study, had a history of disease and illness for at least 03 months prior to the commencement of the study. Other exclusion criteria include any medical or surgical conditions which may hinder physical performance e.g. evidence of inflammatory joint disease and lower limb pathology, recent fracture of the spine, past history of operative intervention for lower back problems, metastatic diseases, anxiety neurosis and depression.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvements in body composition variables such as reduction in body mass and increase in lean body mass. Enhanced Physical (Strength, Power, Speed) and Physiological (lung functions, heart rate, heart rate variability, maximum aerobic capacity) variables. |
Baseline at 0 week, Mid Intervention at 8 week, Post Intervention at 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Standardization of training load depending on Heart Rate Variability, Rating of Perceived Exertion for improvement of performance in football players. |
Baseline at 0 week, Mid Intervention at 8 weeks, Post Intervention at 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For the present study two hundred forty (n= 240) male participants (age: 12-18 years) will be randomly included. The participants will be equally divided into - (i) Control Group (CG, n = 120), and (ii) Experimental Group (EG, n = 120). Both the groups will be further subdivided into three age groups: (A) 12 to 13.99 years (n = 40), (B) 14 to 15.99 years (n = 40), and (C) 16 to 18 years (n = 40). The participants of the experimental group will receive football specific training given by qualified coaches, whereas no training will be given to the participants of the control group. The study will be divided in two phases- (i) First Phase: training will be given following schedule 1 (existing training schedule: 2 hours/ day, 5 days/week, for 12 weeks), (ii) Second Phase: training will be given following schedule 2 (modified training schedule: 2 hours/ day, 5 days/week, for 12 weeks), however, the volume and intensity of different training modalities will differ in first and second phases of study. The nutritional status, body composition, physical fitness, physiological, and biochemical variables will be measured at 0 week (baseline), 8 weeks (mid intervention) and 12 weeks (post intervention) for both the phases of study. Training load will be assessed by heart rate variability and rating of perceived exertion for both the phases of the study. The data will be statistically analysed and interpret. The training load and training associated adaptations will be compared between the two phases of study for standardisation of training load. |