Incentive Spirometry in Routine Management of COPD Patients

NCT05679609 | Completed

• 1 other identifier: 6/2022CHES4-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

COPD; incentive spirometry; diaphragmatic ultrasound

Outcome Measures

Primary Outcomes (7)

• assessing the change in baseline diaphragmatic excursion in cm

  assessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months

  2 months

• assessing the change in baseline percentage of diaphragmatic thickness fraction

  assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months

  2 months

• assessing the change in baseline forced vital capacity percentage of predicted

  assessing the change from baseline forced vital capacity percentage of predicted (%) using spirometry to 2 months

  2 months

• assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%)

  assessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months

  2 months

• assessing the change in baseline peak expiratory flow rate percentage

  assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months

  2 months

• change in arterial blood gases

  assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months

  2 months

• assessing the change in mMRC dysnea scale

  assessing the change in the severity of dyspnea by mMRC dysnea scale from baseline to 2 months. It is 5 statements giving grades from 0 to 4 with the higher the degree, the more severe the shortness of breath in patients with COPD

  2 months

Study Arms (2)

group 1

EXPERIMENTAL

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

Device: incentive spirometry

group 2

NO INTERVENTION

participants would receive only ordinary medical treatment for 2 months

Interventions

incentive spirometry 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 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Amal A. El-Koa

Cairo, Egypt

Location

Related Publications (10)

• 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.

  PMID: 32526187 BACKGROUND

• 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.

  PMID: 11069801 BACKGROUND

• 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.

  PMID: 23233798 BACKGROUND

• 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.

  PMID: 18488439 BACKGROUND

• 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.

  PMID: 19999956 BACKGROUND

• 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.

  PMID: 3881226 BACKGROUND

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

  PMID: 10145589 BACKGROUND

• 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.

  PMID: 9154855 BACKGROUND

• 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.

  PMID: 10935679 BACKGROUND

• 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.

  PMID: 35330474 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 11, 2023
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 11, 2023

Record last verified: 2022-12

Locations

EG (1)