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

Primary Purpose

COPD Exacerbation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Chest Physiotherapy
Conventional Chest Physiotherapy+Incentive Spirometry
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD, incentive spirometry, length of stay, hemodynamic responses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meltem Kaya
  • Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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.

In addition to conventional chest physiotherapy program, patients in this group will also be taught to use Triflo ® and apply at two-hour intervals.

Outcomes

Primary Outcome Measures

Oxygen saturation
The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter.
Heart rate
The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter.
Systolic and diastolic blood pressure
Blood pressure will be measured before and after physiotherapy program with monometer from the arm
Respiratory rate
Blood pressure will be measured before and after physiotherapy program with observation
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
November 18, 2019
Last Updated
April 14, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04170361
Brief Title
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
Official Title
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD, incentive spirometry, length of stay, hemodynamic responses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
In addition to conventional chest physiotherapy program, patients in this group will also be taught to use Triflo ® and apply at two-hour intervals.
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy+Incentive Spirometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter.
Time Frame
30 minutes
Title
Heart rate
Description
The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter.
Time Frame
30 minutes
Title
Systolic and diastolic blood pressure
Description
Blood pressure will be measured before and after physiotherapy program with monometer from the arm
Time Frame
30 minutes
Title
Respiratory rate
Description
Blood pressure will be measured before and after physiotherapy program with observation
Time Frame
30 minutes
Title
Forced Vital Capacity (FVC)
Description
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)
Time Frame
30 minutes
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
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)
Time Frame
30 minutes
Title
Peak Expiratory Flow (PEF)
Description
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)
Time Frame
30 minutes
Title
Forced Expiratory Volume 25-75%
Description
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)
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Kaya, PT, PhD(c)
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meltem Kaya
City
İstanbul
ZIP/Postal Code
34050
Country
Turkey
Facility Name
Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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