| CTRI Number |
CTRI/2024/02/062908 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Inspiratory Muscle Training] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of respiratory muscle training in football players. |
|
Scientific Title of Study
|
Effect of respiratory muscle training on pulmonary function, lung ventilation and aerobic capacity in young football players: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-1853 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khan Waquar Basharatullah |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Aurangabad |
| Address |
Room no.48 Mard Hostel Government Medical College Aurangabad, Near panchakki road , Aurangabad
Government Medical College Aurangabad, Near panchakki road , Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7020844261 |
| Fax |
|
| Email |
dr.waquar010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSayed Ashfak AH |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Aurangabad |
| Address |
Department of Physiology, Government Medical College Aurangabad, Near panchakki road , Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9423352574 |
| Fax |
|
| Email |
sayedashfak123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSayed Ashfak AH |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Aurangabad |
| Address |
Department of Physiology, Government Medical College Aurangabad, Near panchakki road , Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9423352574 |
| Fax |
|
| Email |
sayedashfak123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Aurangabad Maharashtra |
|
|
Primary Sponsor
|
| Name |
Khan Waquar Basharatullah |
| Address |
Room no.48, Mard Hostel, Government Medical College Aurangabad Near Panchakki road Aurangabad Aurangabad |
| 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 |
| Dr Khan Waquar Basharatullah |
Government medical college and Hospital, Aurangabad near panchakki road Aurangabad |
Research Lab Room, Department of Physiology
Aurangabad
MAHARASHTRA |
7020844261
dr.waquar010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Football Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inspiratory muscle training |
Inspiratory muscle training using Respironics Philips machine, prior to to regular soccer training of 4 days a week for 12 weeks |
| Comparator Agent |
Regular Soccer Training |
Regular Soccer Training for 4 days a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Male Football Players aged 18 to 30 years playing more than 5 years of club level football
No history of pulmonary disease
acknowledged their good health condition. |
|
| ExclusionCriteria |
| Details |
Not willing to participate
not available for
training sessions
any contraindication to respiratory muscle training
Smokers
evidence of respiratory restriction or obstruction on spirometry
known case of diabetes mellitus hypertention or any cardiac disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pulmonary function i.e vital capacity (VC), forced vital capacity (FVC), forced expiratory volume in first second (FEV1) and peak expiratory flow (PEF) and lung ventilation i.e using static measurements (PImax and PEmax) or dynamic manoeuvres (maximal voluntary ventilation, MVV). |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aerobic capacity i.e by
determining the maximum oxygen consumption (VO2max).
|
3 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="6"
Days="0" |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.waquar010@gmail.com].
- For how long will this data be available start date provided 06-01-2025 and end date provided 06-01-2030?
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
|
Male Football Players aged 18 to 30 years playing more than 5 years of club level Football will be selected by counseling after visits to football grounds and academies. Information sheet will be given and Informed consent taken from each participant. Detailed history and clinical examination will be done & Baseline parameters like age, weight, height, BMI will be recorded. Participants will be assigned to two groups by computer generated randomization process; experimental (n=10) and control (n=10).During the 12-week experimental period, both group continued their regular preseason soccer training including endurance workouts. Regular soccer training sessions will be performed four times per week under the supervision of a coach. The experimental group will perform additional IMT with a commercially available respiratory muscle trainer (Threshold IMT; Philips Respironics, Inc., Murrysville, PA, USA). The players will be instructed not to participate in any other vigorous physical activities during the study period other than those stated. Pre and post-intervention tests of pulmonary function, Lung ventilation and endurance performance will be implemented. The participants will be instructed to adhere to their usual diet and to not engage in strenuous activity the day before testing. On the test day, the participants were asked to not eat for at least 2h before testing. For each participant, testing will be scheduled at a similar time of day (±0.5h) to minimize the effects of diurnal fluctuation. Test of Pulmonary function, lung ventilation and Aerobic capacity will be assessed before and after intervention in both groups as per standard protocol. |