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

NCT04170361 | Completed

• 1 other identifier: bvumkaya02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD Exacerbation

Keywords

COPD; incentive spirometry; length of stay; hemodynamic responses

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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; Other: Conventional Chest Physiotherapy+Incentive Spirometry

Interventions

Conventional Chest Physiotherapy OTHER

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.

Control Group; Training Group

Conventional Chest Physiotherapy+Incentive Spirometry OTHER

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.

Training Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Meltem Kaya

Istanbul, 34050, Turkey (Türkiye)

Location

Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

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 Officials

• Meltem Kaya, PT, PhD(c)

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: September 21, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 22, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

TU (2)