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NCT Number: NCT06308302

Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients

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).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Fatigue Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital

Lahore, Punjab Province, 42000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A (Inspiratory Muscles Training + Aerobic Interval Training)

Other

Performed Inspiratory muscle training on a breather device (20), (10 inhales with maximum 3-sec hold), 3 sets with a 1-minute interval between each set, for 6 days a week along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40 minutes in 3rd week, 45-60 minutes in 4th week each session). (120)

Baseline treatment given is Aerobic interval training and COPD medications.

Group B (Expiratory Muscles Training +Aerobic Interval Training)

Other

Performed Expiratory muscle training along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40-45 minutes in 3rd week, 45-60 minutes in 4th week per session). (120)

Baseline treatment given is Aerobic interval training and COPD medications.

Primary outcomes

  1. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: 4 Weeks

    A widely recognized tool for evaluating the level of breathlessness experienced by patients with COPD. It provides a simple and efficient method of assessing the baseline functional disability due to dyspnea. experiencing breathlessness with strenuous exercise.

    The scale ranges from 0 to 4, with each grade representing a different level of breathlessness, from only experiencing breathlessness with strenuous exercise (Grade 0) to being too breathless to leave the house or experiencing breathlessness when dressing or undressing (Grade 4).

  2. 6 Minute Walk Test

    Time frame: 4 Weeks

    The 6-Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance, particularly in patients with COPD. The score of the 6MWT is the distance a patient walks in 6 minutes. The patient may take as many standing rests as they like, but the timer should keep going. The 6MWT measures exercise tolerance in people with various health conditions.

  3. Karnofsky Performance Scale (KPS)

    Time frame: 4 Weeks

    The Karnofsky Performance Scale (KPS) is an assessment tool used to predict the length of survival in terminally ill patients.It's an 11-point rating scale ranging from normal functioning (100) to dead (0) in ten-point increments. The higher the score, the more independent the person is.

  4. Fatigue Severity Scale (FSS)

    Time frame: 4 week

    A tool used to measure the severity of fatigue in patients with Chronic Obstructive Pulmonary Disease (COPD). It's a 9-item questionnaire where each item is scored on a 7-point scale, with 1 indicating strong disagreement and 7 indicating strong agreement. The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.

  5. FEV1

    Time frame: 4 Weeks

    A Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. It is often used to diagnose and monitor conditions like COPD. The spirometer measures the Forced Expiratory Volume in 1 second (FEV1), which is how much air you can exhale in the first second after a full inhalation. The FEV1 and FVC values are used to diagnose conditions like COPD.

  6. FVC

    Time frame: 4 weeks

    Digital Spirometer will be used to measure the volume and speed of air a person can inhale and exhale. The spirometer measures the Forced Vital Capacity (FVC), which is the largest amount of air that you can forcefully exhale after breathing in as deeply as you can. Pre-post reading will be taken. it is measures in liters.

  7. FEV1/FVC

    Time frame: 4 weeks

    Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. The FEV1 and FVC values are used to diagnose conditions like COPD. The ratio of FEV1 to FVC (FEV1/FVC) is calculated and expressed as a percentage. Pre-Post readings will be taken.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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