Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients
NCT ID: NCT06308302
Last Updated: 2024-03-13
Study Results
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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COMPLETED
NA
53 participants
INTERVENTIONAL
2023-05-23
2024-02-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A
Group A (Inspiratory Muscles Training +Aerobic Interval Training)
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
Group B (Expiratory Muscles Training +Aerobic Interval Training)
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
55 Years
ALL
Yes
Sponsors
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Riphah International University
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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REC/RCR&AHS/23/0355
Identifier Type: -
Identifier Source: org_study_id
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