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Clinical Trials/CTRI/2026/03/106880
CTRI/2026/03/106880
Not yet recruiting
Not Applicable

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

Not provided1 site in 1 country62 target enrollmentStarted: November 9, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
62
Locations
1
Primary Endpoint
decline percentage of forced expiratory volume for 1 second

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Recent respiratory infection (more than 4 weeks).
  • Significant comorbidities (e.g., cardiovascular disease, diabetes mellitus asthma ).
  • Participation in conflicting clinical trials.
  • Pregnancy or lactation.

Outcomes

Primary Outcomes

decline percentage of forced expiratory volume for 1 second

Time Frame: decline percentage of forced expiratory volume for 1 second

Secondary Outcomes

  • IMP(EMP)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

vishagh kumar v nair

Bharati Vidyapeeth (DU) School of Physiotherapy, Sangli

Study Sites (1)

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