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CTRI Number  CTRI/2024/05/067035 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Aerobic Exercise Benefits for Volleyball Players: Enhancing Cardiopulmonary, Physical, and Psychological Health 
Scientific Title of Study   Effect Of Aerobic Exercise On Cardiopulmonary, Physical and Psychological Health In Volleyball Players 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shabnam Kumari 
Designation  Research student 
Affiliation  Galgotias University 
Address  B-319,Galgotias university Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7480082521  
Fax    
Email  skfeb570@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chhavi Kumar Sharma 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  E Block room no 003 Galgotias university E Block room no 003 Galgotias university Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9410062830  
Fax    
Email  chhavisharma701@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Km ranjana jadon 
Designation  student 
Affiliation  galgotias university 
Address  Galgotias university Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8433209824  
Fax    
Email  Ranjanajadonsirsaganj@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201  
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shabnam Kumari  Galgotias University  B319 Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 2032 Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 
7480082521

skfeb570@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volleyball Players 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrating Aerobic exercise   Intervention: Participant Selection: Select 34 collegiate or competitive-level volleyball players aged 18-30 who meet inclusion criteria. Randomization: Randomly assign participants into two groups: Group A (experimental) and Group B (control). Baseline Assessment: Collect baseline data on cardiovascular and respiratory parameters, physical fitness, and psychological well-being for all participants. Group A Intervention: Description: Implement a structured aerobic exercise intervention based on established guidelines for cardiovascular health. Components: Include a combination of cardiovascular exercises such as running, cycling, or swimming, targeting a specific intensity and duration. Frequency: Prescribe exercise sessions to be conducted [number] times per week for [duration] minutes per session. Duration: Conduct the intervention over 4 weeks, with sessions adjusted based on individual fitness levels. Adherence Monitoring: Monitor adherence to the exercise protocol throughout the study period. Post-Intervention Assessment: After 4 weeks, collect post-intervention data using the same assessment tools as baseline. Data Analysis: Analyze collected data to compare changes in cardiovascular parameters, physical fitness, and psychological well-being between Group A and Group B.  
Comparator Agent  Traditional training regime  Comparator: Participant Selection: Select 34 collegiate or competitive-level volleyball players aged 18-30 who meet inclusion criteria. Randomization: Randomly assign participants into two groups: Group A (experimental) and Group B (control), with 17 participants in each. Baseline Assessment: Collect baseline data on cardiovascular and respiratory parameters, physical fitness, and psychological well-being for all participants. Group B (Control): Description: Participants in Group B will maintain their regular volleyball training routine without additional aerobic exercise. Routine Details: Specify the frequency, duration, and intensity of the regular volleyball training sessions. Adherence Monitoring: Monitor adherence to the regular volleyball training routine throughout the study period. Study Duration: Conduct the study over 4 weeks, maintaining the same timeframe as the intervention group. Post-Intervention Assessment: After 4 weeks, collect post-intervention data using the same assessment tools as baseline for Group B. Data Analysis: Analyze collected data to compare changes in cardiovascular parameters, physical fitness, and psychological well-being between Group A (experimental) and Group B (control). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)Collegiate or competitive-level volleyball players.
2)Age range between 18 and 30 years.
3)Regular engagement in volleyball training and competitions.
4)Willingness to comply with the study. protocol 
 
ExclusionCriteria 
Details  1)Any pre-existing cardiovascular or respiratory conditions that may limit aerobic exercise participation.
2)Recent injuries that restrict physical activity.
3)Individuals on medication that could affect exercise performance.
4)Those unwilling or unable to commit to the study requirement.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cardiopulmonary, Physical and Psychological Health  4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   19/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
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   In the world of teenage physical development, playing sports and taking physical education classes are really important. Especially for students who are into competitive activities like volleyball, these organized exercises are a crucial part of staying healthy. Volleyball requires both tough physical training and mental strength, so it’s essential for overall well-being. During adolescence, when the body is changing a lot and the mind is working hard, it’s important to have a specific plan to stay fit and avoid feeling tired. Building a strong foundation of physical health during this time sets the stage for being healthy throughout life. Physical education is a key part of this process. It’s designed to help people grow individually and socially by doing activities that work out major muscle groups while keeping physical, mental, and social harmony in mind. The goal is not just to learn basic physical skills but also to use free time in a positive and purposeful way. At the same time, it aims to improve learning, support social and emotional development, and boost fitness levels. However, there’s an ongoing debate about what physical education should include. In many places, schools are focusing less on physical activity, maybe because of issues like not having enough facilities. This shift raises important questions about how it might affect the well-being of people involved in intense sports like volleyball. This study wants to understand how regular aerobic exercise affects the heart, lungs, and mental well-being of dedicated volleyball players. By looking into this specific group, we hope to find insights that can help create better training plans, making sure these athletes are physically and mentally healthy. Our exploration aims to add to the conversation about teenage health, especially for those in competitive sports. Understanding the connection between exercise, heart and lung health, and mental well-being in this context is crucial for the overall development of young athletes. It doesn’t just deal with their performance on the volleyball court but also affects their health long after their sports careers are over. As the demands of competitive sports change, taking care of young athletes becomes important not only for their success but also for the growth of sports as a whole. This study wants to fill gaps in current knowledge, offering a detailed view of the benefits of aerobic exercise for dedicated volleyball players. Our goal is to help coaches, trainers, and sports scientists create specific training plans that improve both the physical and mental well-being of these athletes. Ultimately, we hope this research encourages a culture. 
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