| CTRI Number |
CTRI/2024/12/078134 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of Inspiratory Muscle Training on Breathing and Endurance in Recreational Basketball Players: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Pulmonary Function and Aerobic Capacity among Recreational Basketball players: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPA SHARMA |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi
Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8240014511 |
| Fax |
|
| Email |
deepasawarn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep Kumar Jangra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitatio |
| Address |
B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi
Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep Kumar Jangra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitatio |
| Address |
B-31/6, Cardiopulmonary Physiotherapy Research Lab Maharishi
Markandeshwar(Deemed to be University), Mullana-Ambala,
Haryana, India Pin 133207
Ambala
HARYANA
133207
India
HARYANA
133207
India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deepa Sharma |
| Address |
Maharishi Markandeshwar institute of physiotherapy and
rehabilitation Maharishi Markandeshwar deemed to be university |
| 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 Mandeep Kumar Jangra |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room No. B-31/6,
Cardiopulmonary
Research Lab,
Department of
Physiotherapy
Ambala
HARYANA |
9416797708
mandeep.jangra@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Recreational Basketball Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inspiratory muscle training |
Inspiratory muscle training will be performed twice a day, 6 days a week for 4 weeks. Inspiratory muscle training will be started with 30 inspiratory efforts with 50% MIP and load will be increased incrementally once 30 breaths became easy to complete. Inspiratory muscle training will be given by instructing the athletes on the uses of inspiratory pressure device (POWER BREATHE) |
| Comparator Agent |
Placebo IMT |
Control group will be provided Sham-inspiratory muscle training with same device but the resistance will be 15% MIP. Sham Inspiratory muscle training will be performed twice a day, 6 days a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Recreational basketball players
Both male and female
Age-18-35 years
Voluntary consent to participate
|
|
| ExclusionCriteria |
| Details |
3.7.2 Exclusion Criteria
• Smoker athletes1
Respiratory pathology1
Cardiac pathology1
Neurological pathology1
Being over-weight (BMI over 30 kg/m2)
Inability to reproduce IMT protocol1
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary functions Aerobic capacity |
After 4 weeks of inspiratory muscle training
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/12/2024 |
| 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="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
|
This study investigates the impact of inspiratory muscle training (IMT) on pulmonary function and aerobic capacity in recreational basketball players through a randomized controlled trial. Participants were divided into two groups: one undergoing IMT and the other undergoing placebo IMT. The findings suggest that IMT significantly improves pulmonary function (e.g., lung volumes and capacities) and enhances aerobic capacity (measured through VO2 max), compared to the control group. These results imply that adding IMT to regular training could benefit athletes by boosting respiratory efficiency and endurance performance .Participants will be randomly assigned to either IMT group or placebo IMT for 4 weeks. Outcome measures include pulmonary function, Aerobic capacity. Patients will be recruited after getting CTRI registration no. |