| CTRI Number |
CTRI/2026/03/106880 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| 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
|
Impact of Modified Respiratory Rehabilitation on Breathing Performance in Long-Distance Runners with Exercise-Induced Bronchospasm: Findings from a Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of a Modified Respiratory Rehabilitation Program on Exercise-Induced Forced Expiratory Volume for 1 second Decline in Long-Distance Runners with Exercise-Induced Bronchospasm: A Randomized Controlled Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vishagh kumar v nair |
| Designation |
PhD Student |
| Affiliation |
Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli |
| Address |
Department of Cardiovascular and respiratory rehabilitation room no 5, 3rd floor, Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli Miraj Road, Wanleswadi, Sangli - 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
7483835035 |
| Fax |
|
| Email |
vishaghnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manal Anthikat |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli |
| Address |
Bharati Vidyapeeth (DU) School of Physiotherapy,3rd floor Sangli Miraj Road, Wanleswadi, Sangli - 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
7483835035 |
| Fax |
|
| Email |
manaal.anthikat@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
vishagh kumar v nair |
| Designation |
PhD Student |
| Affiliation |
Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli |
| Address |
Department of Cardiovascular and respiratory rehabilitation room no 5, 3rd floor Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli Miraj Road, Wanleswadi, Sangli - 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
7483835035 |
| Fax |
|
| Email |
vishaghnair@gmail.com |
|
|
Source of Monetary or Material Support
|
| This study was conducted at the Department of Cardiovascular and Respiratory Physiotherapy, Bharati Vidyapeeth (Deemed to be University) School of Physiotherapy, Sangli, which provided the necessary infrastructural support for the research. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIl] |
|
|
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 Vishagh Kumar V Nair |
bharatividyapeeth deemed tobe university sangli |
Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli Miraj Road, Wanleswadi, Sangli - 416416
Sangli
MAHARASHTRA |
07483835035
vishaghnair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharatividyapeeth Deemed to be University sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
bronchospasam |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Respiratory Rehabilitation Program |
A 5-week modified respiratory rehabilitation program comprising:
10-minute warm-up
3 minutes of diaphragmatic breathing (4s inhale, 6s exhale)
15 minutes of High-Intensity Interval Respiratory Training (HIIRT) with inspiratory load progression from 30 percent MIP to maximum tolerated load
10 minutes of advanced breathing coordination techniques (3:2 inhale–exhale ratio)
15 minutes of structured running at 75–85 percent HRmax with controlled breathing
5-minute cool-down and relaxation
Sessions will be conducted 3–5 times per week under physiotherapist supervision. |
| Comparator Agent |
Standard Aerobic Exercise Training |
A 5-week standard aerobic training program including:
10-minute warm-up
15-minute low-intensity aerobic activity (brisk walking or cycling at 40 to 70 percent HRmax)
20-minute stretching and mobility exercises
10-minute cool-down with relaxation and breathing recovery exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age 18–45 years.
On screening, confirmed EIB FEV 1 decline of more than 10 percent
Actively training long-distance runners more than 40 km per week
No chronic respiratory conditions
Willing to complete 5 week intervention and assessments
|
|
| ExclusionCriteria |
| Details |
Recent respiratory infection (more than 4 weeks).
Significant comorbidities (e.g., cardiovascular disease, diabetes mellitus asthma ).
Participation in conflicting clinical trials.
Pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decline percentage of forced expiratory volume for 1 second |
decline percentage of forced expiratory volume for 1 second |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IMP
EMP
FVC
Exercise tolerance test
health-related quality of life questionnaire
|
baseline, 3 weeks, 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
09/11/2026 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
This randomized controlled trial evaluates the effectiveness of a 5-week Modified Respiratory Rehabilitation Program compared to standard aerobic exercise in improving lung function and exercise tolerance in long-distance runners with Exercise-Induced Bronchospasm. The study targets 146 participants aged 18-45 years who are actively training long-distance runners experiencing at least 10 percent decline in Forced Expiratory Volume in 1 second after exercise challenge. Participants will be randomly assigned to either the intervention group receiving Modified Respiratory Rehabilitation, including High-Intensity Interval Respiratory Training, breathing pattern optimization, and sport-specific running protocols, or the control group receiving standard aerobic exercise training. Both groups will undergo supervised 5-week programs conducted by qualified physiotherapists. The primary outcome is the post-exercise FEV1 decline percentage. Secondary outcomes include inspiratory and expiratory muscle strength, exercise tolerance measured by VO2 Max, and health-related quality of life using the SF-36 questionnaire. Assessments will be conducted at baseline and after 5 weeks of intervention. The study aims to provide evidence for non-pharmacological management of Exercise-Induced Bronchospasm in competitive athletes, offering an alternative approach that aligns with anti-doping regulations and holistic training preferences. This research addresses a significant gap in respiratory rehabilitation applications for athletes with exercise-induced airway narrowing and may inform clinical guidelines for this population. |