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Clinical Trials/CTRI/2025/09/094149
CTRI/2025/09/094149
Not yet recruiting
Phase 1

THRESHOLD TRAINING VERSUS BIOFEEDBACK TRAINING ON MORPHOLOGICAL CHANGES IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE

S. SATHYA1 site in 1 country126 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Phase 1
Status
Not yet recruiting
Sponsor
S. SATHYA
Enrollment
126
Locations
1
Primary Endpoint
Pulmonary functions using Spirometer and morphological changes in lungs using CT scan

Overview

Brief Summary

This experimental study aims to evaluate the effects of threshold training, biofeedback training and conventional training on improving the  morphological changes in subjects with stable moderate COPD aged 45-65 years. The study will be conducted at the out patient department of Faculty of physiotherapy, department of pulmonology, ACS medical college and hospital, which involves 126 both male and female subjects divided into three groups with 42 participants in each group, undergoing 45 minute sessions four times weeekly over a period of 12 weeks. The primary aim is to investigate the effectiveness of these interventions in improving the morphological changes and pulmonary functions among the copd subjects. The primary objective being a comparitive analysis of  threshold training versus biofeedback training on morphological changes in copd. Secondary objectives includes assesing the individual effects of each intervention like threshold trainin, biofeedback training and conventional training on these parameters. Outcome measures encompass lung functions, inspiratory muscle strength, morphological changes in lungs and quality of life. The results will be revealed after the intervention period and its intended to identify the most effective physiotherapy approach for improving the lung condition and functional capacity in subjects with copd.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
45.00 Day(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Stable moderate COPD subjects both male and female under the age group of 45-65 years, FEV1/FVC RATIO 60-59%.

Exclusion Criteria

  • Subjects with severe COPD and chest infections, severe or unstable cardiac diseases, recent thoracic surgeries and severe exacerbation.

Outcomes

Primary Outcomes

Pulmonary functions using Spirometer and morphological changes in lungs using CT scan

Time Frame: Pulmonary functions and morphological changes in lungs

Secondary Outcomes

  • Inspiratory muscle strength and quality of life(Inspiratory muscle strength and quality of life)

Investigators

Sponsor
S. SATHYA
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

S Sathya

MMM college of health sciences

Study Sites (1)

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