Combined Effects Of Percussion With Diaphragmatic Breathing Exercises On Airway Clearance In Elderly Pneumonia Patients

June 12, 2024 updated by: Riphah International University

Combined Effects of Percussion With Diaphragmatic Breathing Exercises on Airway Clearance in Elderly Pneumonia Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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
Experimental: 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
Other: , 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BCSS
Time Frame: 4 weeks
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
HRQOL for quality of life
Time Frame: 4 weeks
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
Rated Perceived Exertion (RPE) Scale
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sidra Faisal, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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