Clinical trial NCT06308302: Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients
Official title: Comparative Effects of Inspiratory Muscle Training vs Expiratory Muscle Training Along With Aerobic Interval Training on Functional Performance and Fatigue Level in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Chronic Obstructive pulmonary disease
Dyspnea
Breathing Exercises
Pulmonary Disease
Fatigue
Functional Performance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.

This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.

Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosed case of COPD.
* Participants must be between the ages of 30 and 55 years old.
* Participants must have GOLD II and III stage COPD.
* Both men and women are eligible for the study.

Exclusion Criteria:

* Participants with a history of cardiovascular disease.
* Participants with a history of neurological disease.
* Participants with a history of orthopaedic disease.
* Participants with a history of neuromuscular disease.
* Participants who had experienced a recent COPD exacerbation within the past 3 months.

Primary outcomes:
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: 4 Weeks
measure: 6 Minute Walk Test
timeFrame: 4 Weeks
measure: Karnofsky Performance Scale (KPS)
timeFrame: 4 Weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 4 week
measure: FEV1
timeFrame: 4 Weeks
measure: FVC
timeFrame: 4 weeks
measure: FEV1/FVC
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital
state: Punjab
Study officials:
affiliation: Ripha International University-LHR
name: Hafiza Muriam Ghani, MSCPPT
role: PRINCIPAL_INVESTIGATOR
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