| CTRI Number |
CTRI/2025/02/081147 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Sleep Quality and Depression Affect Endurance in Football Players: A Cross-Sectional Study |
|
Scientific Title of Study
|
IMPACT OF QUALITY OF SLEEP AND DEPRESSION ON ENDURANCE PERFORMANCE AMONG FOOTBALL PLAYERS:AN OBSERVATIONAL CROSS-SECTIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saptarshi Mondal |
| Designation |
MPT student |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Kancheepuram TAMIL NADU 603203 India |
| Phone |
7980015808 |
| Fax |
|
| Email |
SAPTARSHI831@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
T S Veeragoudhaman |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Kancheepuram TAMIL NADU 603203 India |
| Phone |
9500375408 |
| Fax |
|
| Email |
veera5vikashini@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
T S Veeragoudhaman |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 Kancheepuram TAMIL NADU 603203 India |
| Phone |
9500375408 |
| Fax |
|
| Email |
SAPTARSHI831@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saptarshi Mondal |
| Address |
Room no: PT05, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, potheri,Kancheepuram pin -603203 |
| Type of Sponsor |
Other [SELF ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saptarshi Mondal |
SRMIST College of Physiotherapy |
Directorate of sports, SRM COLLEGE OF PHYSIOTHERAPY, SRM sports lab, SRM Nagar,Kattankulathur, Potheri,Kancheepuram pin -603203 Kancheepuram TAMIL NADU |
7980015808
sm2446@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital And Research Centre Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fully fit and healthy football players.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Male |
| Details |
1. Football players
2. Individuals following commands
3. Informed consent from player
4. Obeys command
5. Only male |
|
| ExclusionCriteria |
| Details |
1. Under medications like Anti-depressants
2. Any current injury that might disturb sleep or performance
3. Any recent surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression anxiety stress scale(DASS-21) |
1-Month duration, once per player. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburg sleep quality index |
1 month duration, once for each player |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
20/03/2025 |
| 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="0" Months="1" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [SAPTARSHI831@GMAIL.COM].
- For how long will this data be available start date provided 25-02-2025 and end date provided 10-02-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In the dynamic realm of sports science, the intricate interplay between various physiological and psychological factors significantly influences athletic performance. Among these factors, sleep quality and mental health, particularly depression, have garnered increasing attention due to their potential impact on athletic performance. In the context of football, a sport that demands both physical endurance and mental resilience, understanding the nexus between sleep, depression, and endurance performance becomes paramount. • Sleep plays a crucial role in the recovery and regeneration of the body, affecting various physiological and cognitive functions. Adequate sleep is not only essential for optimal physical performance but is also closely linked to mental health. On the other hand, depression, a prevalent mental health concern, can have profound effects on an athlete’s overall well-being, including sleep patterns and cognitive function. • Insufficient sleep and poor sleep quality are prevalent among athletes, potentially due to time demands, physical demands, and developmental needs. Sleep disturbances among athletes have adverse impacts on physical performance, mental performance, injury risk and recovery, medical health, and mental health. [1] • Despite all the efforts expended, by any definition, numerous athletes still experience inadequate sleep. Compared with nonathletes, athletes tend to sleep less on average[2] • This research focuses on unravelling the intricate relationship between endurance performance and two critical factors: the quality of sleep and the presence of depression among football players. The endurance demands of football require players to operate at peak physical and mental capacities, making the exploration of these interconnected variables imperative for a comprehensive understanding of athletic performance |