- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679609
Incentive Spirometry in Routine Management of COPD Patients
December 23, 2022 updated by: Amal A. El-Koa, Menoufia University
Value of Incentive Spirometry in Routine Management of COPD Patients and Its Effect on Diaphragmatic Function
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Amal A. El-Koa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group 1
participants would use incentive spirometry for 2 months together with ordinary medical treatment
|
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.
|
No Intervention: group 2
participants would receive only ordinary medical treatment for 2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessing the change in baseline diaphragmatic excursion in cm
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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 (%)
Time Frame: 2 months
|
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
Time Frame: 2 months
|
assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months
|
2 months
|
change in arterial blood gases
Time Frame: 2 months
|
assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months
|
2 months
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assessing the change in mMRC dysnea scale
Time Frame: 2 months
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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
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- AARC (American Association for Respiratory Care) clinical practice guideline. Incentive spirometry. Respir Care. 1991 Dec;36(12):1402-5. No abstract available.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
December 23, 2022
First Posted (Estimate)
January 11, 2023
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
December 23, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 6/2022CHES4-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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