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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06461884
Other study ID # REC/RCR & AHS/23/0379
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2024
Est. completion date July 15, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Iqbal Tariq, PHD
Phone O3338236752
Email iqbal.tariq@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients.


Description:

It will be a randomized clinical trial. And the data will be conducted from Mayo Hospital Lahore. Convenient sampling technique will be applied on patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A and group B to collect data. For this purpose, I will divide my sample size into two groups. The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients. Before and after each session, the primary and secondary outcomes will be measured for both groups. After collecting the data, the data will be analyzed by using SPSS version 25.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Patients aged 40-60, - Both males and females - Those patients who will be vitally stable (oxygen saturation, respiratory rate) - Pneumonia diagnosed patients (Community Acquired Pneumonia) Exclusion Criteria: - Patients with heart disease - Patients with neurological disorders such as: Alzheimer, epilepsy, Parkinson disease - Patients with orthopedic conditions - Other pulmonary complications (atelectasis, diaphragmatic injury, ARDS)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Percussions
Group A: Percussions and diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks
, Diaphragmatic breathing exercise
Group B: Diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks

Locations

Country Name City State
Pakistan Mayo Hospital Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Brar NK, Niederman MS. Management of community-acquired pneumonia: a review and update. Ther Adv Respir Dis. 2011 Feb;5(1):61-78. doi: 10.1177/1753465810381518. Epub 2010 Oct 8. — View Citation

Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. doi: 10.1086/425615. Epub 2004 Nov 8. — View Citation

Marchello CS, Ebell MH, Dale AP, Harvill ET, Shen Y, Whalen CC. Signs and Symptoms That Rule out Community-Acquired Pneumonia in Outpatient Adults: A Systematic Review and Meta-Analysis. J Am Board Fam Med. 2019 Mar-Apr;32(2):234-247. doi: 10.3122/jabfm.2019.02.180219. — View Citation

Miyashita N, Yamauchi Y. Bacterial Pneumonia in Elderly Japanese Populations. Jpn Clin Med. 2018 Jan 3;9:1179670717751433. doi: 10.1177/1179670717751433. eCollection 2018. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary BCSS BCSS: BCSS is a patient-reported three-item questionnaire for cough, breathlessness and sputum rating on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). 4 weeks
Primary HRQOL for quality of life One of the many factors frequently investigated in the realm of medical research and treatment is HRQOL. It covers a broad spectrum of man experience, contains how we operate and how we perceive illness. The World Health Organization defines health as a condition of whole physical, intellectual, and interpersonal well-being and not just the absence of disease, which is the foundation for modern interpretations of HRQOL. 4 weeks
Primary Rated Perceived Exertion (RPE) Scale Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes. The RPE scale can help you manage exercise intensity and improve cardio training and endurance 4 weeks
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