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

NCT ID: NCT06308302

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-02-15

Brief Summary

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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).

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Group A (Inspiratory Muscles Training +Aerobic Interval Training)

Group Type EXPERIMENTAL

Group A (Inspiratory Muscles Training + Aerobic Interval Training)

Intervention Type 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

Group B (Expiratory Muscles Training +Aerobic Interval Training)

Group Type EXPERIMENTAL

Group B (Expiratory Muscles Training +Aerobic Interval Training)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Muriam Ghani, MSCPPT

Role: PRINCIPAL_INVESTIGATOR

Ripha International University-LHR

Locations

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Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 35279265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31987882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34403023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37474226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37474208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30846341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32198215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35688435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31861418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36510485 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/0355

Identifier Type: -

Identifier Source: org_study_id

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