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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04170361
Other study ID # bvumkaya02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2021
Est. completion date March 22, 2022

Study information

Verified date April 2022
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date March 22, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation Istanbul
Turkey Meltem Kaya Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygen saturation The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter. 30 minutes
Primary Heart rate The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter. 30 minutes
Primary Systolic and diastolic blood pressure Blood pressure will be measured before and after physiotherapy program with monometer from the arm 30 minutes
Primary Respiratory rate Blood pressure will be measured before and after physiotherapy program with observation 30 minutes
Primary 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
Primary 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
Primary 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
Primary 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
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