Incentive Spirometry in Routine Management of COPD Patients

NCT ID: NCT05679609

Last Updated: 2023-01-11

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-07-01

Brief Summary

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The incentive spirometer is a device that encourages patients, with visual and other positive feedback, to maximally inflate their lungs and sustain that inflation. However, its efficacy in patients with COPD has been little documented especially in diaphragmatic function. This study tried to assess the role of incentive spirometry on Spirometric functions, Sonographic diaphragmatic function, and the scale of dyspnea in COPD patients with exacerbation and with follow-up of these parameters after 2 months.

Detailed Description

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Forty COPD patients were admitted with an acute exacerbation and the patients were divided randomly into 2 equal groups: the first used the incentive spirometer together with medical treatment (according to GOLD guidelines) for 2 months and the second received only medical treatment for 2 months. All participants, on admission, underwent assessment of mMRC dyspnea scale, spirometry, arterial blood gases, and diaphragmatic ultrasound. Then, a follow-up of the participants was done after 2 months with the same parameters and a comparison between both groups was done.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

participants would use incentive spirometry for 2 months together with ordinary medical treatment

Group Type EXPERIMENTAL

incentive spirometry

Intervention Type DEVICE

It is flow-oriented that has 3 chambers, (600, 900, and 1200 cc/s) and it has a mouthpiece and a ball in each chamber. After a quiet exhalation, each participant was instructed to take slow full inspirations and to keep as long as he can for at least 5 seconds, then he slowly expires. The device is used every hour at least 5 to 10 times in the session during wake time.

group 2

participants would receive only ordinary medical treatment for 2 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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incentive spirometry

It is flow-oriented that has 3 chambers, (600, 900, and 1200 cc/s) and it has a mouthpiece and a ball in each chamber. After a quiet exhalation, each participant was instructed to take slow full inspirations and to keep as long as he can for at least 5 seconds, then he slowly expires. The device is used every hour at least 5 to 10 times in the session during wake time.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* confirmed cases of COPD according to the criteria GOLD
* age more than 40 years

Exclusion Criteria

* bad acoustic window by ultrasound
* other chronic respiratory diseases
* lung malignancy
* recent major surgery
* inability to complete or perform the study
* patient refusal
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Amal A. El-Koa

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amal A. El-Koa

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.

Reference Type BACKGROUND
PMID: 32526187 (View on PubMed)

Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.

Reference Type BACKGROUND
PMID: 11069801 (View on PubMed)

Petrovic M, Reiter M, Zipko H, Pohl W, Wanke T. Effects of inspiratory muscle training on dynamic hyperinflation in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:797-805. doi: 10.2147/COPD.S23784. Epub 2012 Nov 30.

Reference Type BACKGROUND
PMID: 23233798 (View on PubMed)

Barakat S, Michele G, George P, Nicole V, Guy A. Outpatient pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2008;3(1):155-62. doi: 10.2147/copd.s2126.

Reference Type BACKGROUND
PMID: 18488439 (View on PubMed)

Cortopassi F, Castro AA, Porto EF, Colucci M, Fonseca G, Torre-Bouscoulet L, Iamonti V, Jardim JR. Comprehensive exercise training improves ventilatory muscle function and reduces dyspnea perception in patients with COPD. Monaldi Arch Chest Dis. 2009 Sep;71(3):106-12. doi: 10.4081/monaldi.2009.355.

Reference Type BACKGROUND
PMID: 19999956 (View on PubMed)

Stock MC, Downs JB, Gauer PK, Alster JM, Imrey PB. Prevention of postoperative pulmonary complications with CPAP, incentive spirometry, and conservative therapy. Chest. 1985 Feb;87(2):151-7. doi: 10.1378/chest.87.2.151.

Reference Type BACKGROUND
PMID: 3881226 (View on PubMed)

AARC (American Association for Respiratory Care) clinical practice guideline. Incentive spirometry. Respir Care. 1991 Dec;36(12):1402-5. No abstract available.

Reference Type BACKGROUND
PMID: 10145589 (View on PubMed)

Casaburi R, Porszasz J, Burns MR, Carithers ER, Chang RS, Cooper CB. Physiologic benefits of exercise training in rehabilitation of patients with severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1541-51. doi: 10.1164/ajrccm.155.5.9154855.

Reference Type BACKGROUND
PMID: 9154855 (View on PubMed)

Darnley GM, Gray AC, McClure SJ, Neary P, Petrie M, McMurray JJ, MacFarlane NG. Effects of resistive breathing on exercise capacity and diaphragm function in patients with ischaemic heart disease. Eur J Heart Fail. 1999 Aug;1(3):297-300. doi: 10.1016/s1388-9842(99)00027-6.

Reference Type BACKGROUND
PMID: 10935679 (View on PubMed)

Cheng YY, Lin SY, Hsu CY, Fu PK. Respiratory Muscle Training Can Improve Cognition, Lung Function, and Diaphragmatic Thickness Fraction in Male and Non-Obese Patients with Chronic Obstructive Pulmonary Disease: A Prospective Study. J Pers Med. 2022 Mar 16;12(3):475. doi: 10.3390/jpm12030475.

Reference Type BACKGROUND
PMID: 35330474 (View on PubMed)

Other Identifiers

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6/2022CHES4-1

Identifier Type: -

Identifier Source: org_study_id

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