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Combined Effects of Blow Bottle Technique and Percussion Technique in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
blow bottle
percussion
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Airway Obstruction, COPD, Dyspnea, Expiratory flow rate, Percussion.

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Mild-to-Moderate COPD (according to GOLD criteria) Both gender (male and female) Aged between 35 and 80 years Exclusion Criteria: Clinically unstable cardiovascular impairment, musculoskeletal dysfunction neurological disease

Sites / Locations

  • DHQ Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Blow Bottle technique

percussion

Arm Description

Blowing with a straw into a water bottle is a good exercise to improve breathing capacity. The user, who has poor pulmonary function, always has his "blow bottle" handy

Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises

Outcomes

Primary Outcome Measures

Dyspnea (Modified Medical Research council)
The mMRC grade is a five-point scale based on the degree of dyspnea a patient. The use of this scale to evaluate symptoms is encouraged by current standards
Breathlessness, cough and sputum scale (BCSS)
In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness
Expiratory flow rate (peak flow meter)
A peak flow rate should be used to capture the highest flow rates. The patient must record the highest reading out of a possible three. The best at the moment is this. A typical chart has dates with AM and PM times, a left margin, and a scale that ranges from 0 litres per minute at the bottom to 600 litres per minute at the top
O2 n pulse rate by Oximeter
A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05922293
Brief Title
Combined Effects of Blow Bottle Technique and Percussion Technique in COPD Patients
Official Title
Combined Effects of Blow Bottle Technique and Percussion Technique in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life (QoL) is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, a lung function exercise bottle is designed, which is capable of adjusting the pressure according to the patient's needs. The exercise bottle is composed of three components, including bottle body, threaded round cap and air blow pipe. Furthermore, manual chest percussion is the rhythmic clapping on the chest wall with relaxed wrist and cupped hand, creating an energy wave that is transmitted to the airways. It is applied with a frequency of approximately 3-6 Hz. To reduce any adverse consequences, the technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises. It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Airway Obstruction, COPD, Dyspnea, Expiratory flow rate, Percussion.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blow Bottle technique
Arm Type
Active Comparator
Arm Description
Blowing with a straw into a water bottle is a good exercise to improve breathing capacity. The user, who has poor pulmonary function, always has his "blow bottle" handy
Arm Title
percussion
Arm Type
Experimental
Arm Description
Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises
Intervention Type
Other
Intervention Name(s)
blow bottle
Intervention Description
When you blow through a tube into water in a bottle, the pressure in the airways increases. This opens up the passageways between bronchioles, allowing air to flow behind the mucus and push it into the larger airways. This way, it will be easy to remove the mucus by coughing or huffing.
Intervention Type
Other
Intervention Name(s)
percussion
Intervention Description
Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises. Do this for a total of 10 breaths, Perform two huffs, and Cough. Close their mouth around the tube and exhale slightly forcefully for 3 seconds to produce bubbles. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized
Primary Outcome Measure Information:
Title
Dyspnea (Modified Medical Research council)
Description
The mMRC grade is a five-point scale based on the degree of dyspnea a patient. The use of this scale to evaluate symptoms is encouraged by current standards
Time Frame
fourth week
Title
Breathlessness, cough and sputum scale (BCSS)
Description
In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness
Time Frame
fourth week
Title
Expiratory flow rate (peak flow meter)
Description
A peak flow rate should be used to capture the highest flow rates. The patient must record the highest reading out of a possible three. The best at the moment is this. A typical chart has dates with AM and PM times, a left margin, and a scale that ranges from 0 litres per minute at the bottom to 600 litres per minute at the top
Time Frame
fourth week
Title
O2 n pulse rate by Oximeter
Description
A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen
Time Frame
fourth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mild-to-Moderate COPD (according to GOLD criteria) Both gender (male and female) Aged between 35 and 80 years Exclusion Criteria: Clinically unstable cardiovascular impairment, musculoskeletal dysfunction neurological disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Tariq, PhD*
Phone
03458236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ Teaching Hospital
City
Gujranwala.
State/Province
Punjab
ZIP/Postal Code
54560
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Phone
03124378540
Email
sidra.afzal@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26937186
Citation
Jones PW, Watz H, Wouters EF, Cazzola M. COPD: the patient perspective. Int J Chron Obstruct Pulmon Dis. 2016 Feb 19;11 Spec Iss(Spec Iss):13-20. doi: 10.2147/COPD.S85977. eCollection 2016.
Results Reference
background
PubMed Identifier
20956146
Citation
Raherison C, Girodet PO. Epidemiology of COPD. Eur Respir Rev. 2009 Dec;18(114):213-21. doi: 10.1183/09059180.00003609.
Results Reference
background
PubMed Identifier
30827317
Citation
Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.
Results Reference
background
PubMed Identifier
18574288
Citation
Celli BR. Update on the management of COPD. Chest. 2008 Jun;133(6):1451-1462. doi: 10.1378/chest.07-2061. Erratum In: Chest. 2008 Oct;134(4):892.
Results Reference
background

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Combined Effects of Blow Bottle Technique and Percussion Technique in COPD Patients

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