The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation

COPD; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. The definition of exacerbation is defined as an acute onset with a change in where daily differences in the main symptoms occur and which may occur with the presence of drugs. The number of exacerbations in the course of the disease is between 1-3 years on average. Routine physiotherapy treatment in COPD exacerbation is expected to increase lung volume and effective removal of airway secretions. The concept of physiotherapy programs is vibration, thoracic expression exercise, positive expiratory pressure therapy and gait programs.

An incentive spirometer is a simple, inexpensive device to adjust lung tissue re-expansion by increasing lung volumes and diaphragmatic mobility, providing maximal inspiration with termination control without a resistive loading. In COPD patients, the use of incentive spirometry is to increase alveolar ventilation and oxygenation in lifestyle.

There are a limited number of studies in the literature regarding the results of the use of incentive spirometry in COPD patients. The results of postoperative results of incentive spirometry in COPD patients were tried and established on pulmonary complications, diseases, postoperative dyspnea perception and lifestyle. The importance of the investigator's research; this is the first study to evaluate hemodynamic responses and hospitalization plans of incentive spirometer and routine physiotherapy program in COPD exacerbations.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: Conventional Chest Physiotherapy; Other: Conventional Chest Physiotherapy+Incentive Spirometry

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
  • İstanbul, Turkey, 34050
    • Meltem Kaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being diagnosed with COPD exacerbation
• Hemodynamically stable
• To be conscious and voluntarily agree to participate in the study

Exclusion Criteria:

• Existence of neurological, cardiovascular and musculoskeletal problems to prevent exercise
• Having chronic respiratory disease other than COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Patients will be admitted to chest physiotherapy program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization.	Other: Conventional Chest Physiotherapy; All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.
Experimental: Training Group; In addition to conventional chest physiotherapy program, patients in this group will also be taught to use Triflo ® and apply at two-hour intervals.	Other: Conventional Chest Physiotherapy; All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.; Other: Conventional Chest Physiotherapy+Incentive Spirometry; All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter.	30 minutes
Heart rate	The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter.	30 minutes
Systolic and diastolic blood pressure	Blood pressure will be measured before and after physiotherapy program with monometer from the arm	30 minutes
Respiratory rate	Blood pressure will be measured before and after physiotherapy program with observation	30 minutes
Forced Vital Capacity (FVC)	FVC will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)	30 minutes
Forced Expiratory Volume in 1 second (FEV1)	FEV1 will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)	30 minutes
Peak Expiratory Flow (PEF)	PEF will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)	30 minutes
Forced Expiratory Volume 25-75%	FEF 25-75% will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)	30 minutes

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Meltem Kaya, PT, PhD(c), Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: COPD; length of stay; incentive spirometry; hemodynamic responses
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: bvumkaya02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No