| CTRI Number |
CTRI/2025/10/095520 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| 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
|
A study on improving fitness and recovery in injured athletes using breathing exercises along with regular rehabilitation |
|
Scientific Title of Study
|
Respiratory muscle training as an adjunct to conventional rehabilitation: a pilot study on enhancing endurance and performance in injured athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thiagarajan Subramanian |
| Designation |
Professor |
| Affiliation |
Lovely professional university |
| Address |
Department of physiotherapy, School of allied medical science, Lovely professional university, Phagwara, Punjab-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
9789247047 |
| Fax |
|
| Email |
strajanpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshaya Momula |
| Designation |
Student- MPT |
| Affiliation |
Lovely professional university |
| Address |
block 3-105, Department of physiotherapy, School of allied medical sciences, Lovely professional university, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
8367301964 |
| Fax |
|
| Email |
momulaakshayammr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshaya Momula |
| Designation |
MPT student |
| Affiliation |
Lovely professional university |
| Address |
Department of physiotherapy, School of allied medical science, Lovely professional university, Phagwara, Punjab-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8367301964 |
| Fax |
|
| Email |
momulaakshayammr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Akshaya Momula |
| Address |
Department of physiotherapy, School of allied medical science, Lovely professional university |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Thiagarajan Subramanian |
Lovely professional university |
Department of physiotherapy, School 0f allied health medical science, Lovely professional university, Phagwara, Punjab-144411
Kapurthala
PUNJAB |
9789247047
strajanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) , LOVELY PROFESSIONAL UNIVERSITY. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Injured athletes. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional training with breathing exercises. |
the participants will receive the conventional rehabilitation and breathing exercise for endurance. |
| Intervention |
Respiratory muscle training. |
Inspiratory Muscle Training (IMT) using a respiratory muscle device, 5 sessions per week for 4 weeks, in addition to conventional rehabilitation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Athletes with lower limb injuries
2.Both genders
3.Endurance and breathing loss
4.Sports participation with in 6months required
5.Willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Any lung diseases
2.Any Cardiovascular conditions
3.Recent abdominal surgeries
4.Smoker
5.Recent respiratory infections
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function test -FEV1, FVC, FEV/FVC [ Forced expiratory volume in first second , forced vital capacity, FEV/FVC-ratio]
Maximal expiratory pressure[MEP]
Maximal inspiratory pressure[ MIP]
|
It will assessed pre-intervention and post-intervention(0 week-4th week)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in endurance and performance capacity of athletes (post-rehabilitation).
Reduction in fatigue perception during physical activity.
Faster return to sports participation compared to control. |
pre-intervention and post-intervention(0week-4th week) |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/10/2025 |
| 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
|
Athletic events results in sports injuries that have the effect of interfering with respiratory efficiency and endurance; thus resulting in longer healing and poorer athletic performance. Traditional treatment methods target the injured location mostly disregarding the respiratory system in recovery of the functional capacity. Respiratory Muscle Training (RMT), notably the Inspiratory Muscle Training (IMT) has proven to build breathing muscles, increasing oxygen uptake, and minimizing fatigue, which leads to faster and more efficient recovery. This pilot randomized control trial proposes to answer the question concerning the effect of RMT as an adjunct to conventional rehabilitation to lower limb-injured athletes aged between 18 and 25 years. Twelve participants will also be placed into an intervention and a control group and perform RMT and standard rehabilitation respectively within a course of four weeks. Pre and post-interventional measures will comprise Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This study will obtain preliminary evidence regarding whether RMT improved respiratory function, endurance, and performance outcomes and, thus, may be a cost-effective, non-invasive way to optimize rehabilitation and possibly an expedited return to sport. |