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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308302
• Other study ID #: REC/RCR&AHS/23/0355
• Status: Completed
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 15, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Group A (Inspiratory Muscles Training + Aerobic Interval Training)
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)
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.

Locations

Country	Name	City	State
Pakistan	Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10. — View Citation

Agarwal D. COPD generates substantial cost for health systems. Lancet Glob Health. 2023 Aug;11(8):e1138-e1139. doi: 10.1016/S2214-109X(23)00304-2. No abstract available. — View Citation

Carter P, Lagan J, Fortune C, Bhatt DL, Vestbo J, Niven R, Chaudhuri N, Schelbert EB, Potluri R, Miller CA. Association of Cardiovascular Disease With Respiratory Disease. J Am Coll Cardiol. 2019 May 7;73(17):2166-2177. doi: 10.1016/j.jacc.2018.11.063. Epub 2019 Mar 4. — View Citation

Chen S, Kuhn M, Prettner K, Yu F, Yang T, Barnighausen T, Bloom DE, Wang C. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023 Aug;11(8):e1183-e1193. doi: 10.1016/S2214-109X(23)00217-6. — View Citation

Gutierrez Villegas C, Paz-Zulueta M, Herrero-Montes M, Paras-Bravo P, Madrazo Perez M. Cost analysis of chronic obstructive pulmonary disease (COPD): a systematic review. Health Econ Rev. 2021 Aug 17;11(1):31. doi: 10.1186/s13561-021-00329-9. — View Citation

Hughes MJ, McGettrick HM, Sapey E. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target. Eur Respir Rev. 2020 Mar 20;29(155):190102. doi: 10.1183/16000617.0102-2019. Print 2020 Mar 31. — View Citation

Landt E, Colak Y, Lange P, Laursen LC, Nordestgaard BG, Dahl M. Chronic Cough in Individuals With COPD: A Population-Based Cohort Study. Chest. 2020 Jun;157(6):1446-1454. doi: 10.1016/j.chest.2019.12.038. Epub 2020 Jan 25. — View Citation

Li Y, Gao H, Zhao L, Wang J. Osteoporosis in COPD patients: Risk factors and pulmonary rehabilitation. Clin Respir J. 2022 Jul;16(7):487-496. doi: 10.1111/crj.13514. Epub 2022 Jun 10. — View Citation

Li Z, Liu S, Wang L, Smith L. Mind-Body Exercise for Anxiety and Depression in COPD Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Dec 18;17(1):22. doi: 10.3390/ijerph17010022. — View Citation

Zou M, Zhang W, Xu Y, Zhu Y. Relationship Between COPD and GERD: A Bibliometrics Analysis. Int J Chron Obstruct Pulmon Dis. 2022 Dec 6;17:3045-3059. doi: 10.2147/COPD.S391878. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Medical Research Council (mMRC) Dyspnea Scale	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).	4 Weeks
Primary	6 Minute Walk Test	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.	4 Weeks
Primary	Karnofsky Performance Scale (KPS)	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 Weeks
Primary	Fatigue Severity Scale (FSS)	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.	4 week
Primary	FEV1	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.	4 Weeks
Primary	FVC	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.	4 weeks
Primary	FEV1/FVC	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.	4 weeks