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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05922293
Other study ID # REC/RCR&AHS/23/0320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date December 5, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 5, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blow bottle
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.
percussion
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

Locations

Country Name City State
Pakistan DHQ Teaching Hospital Gujranwala. Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Raherison C, Girodet PO. Epidemiology of COPD. Eur Respir Rev. 2009 Dec;18(114):213-21. doi: 10.1183/09059180.00003609. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 fourth week
Primary 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 fourth week
Primary 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 fourth week
Primary 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 fourth week
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