Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique in COPD Patients

December 26, 2023 updated by: Riphah International University

Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique on Sputum Diary, Oxygen Saturation, Expiratory Flow Rate, and Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. In Costophrenic assist, the therapist gives a quick stretch to the diaphragm and intercostals with repetitions. The patientt holds air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist. In Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion. A total 34 patients will be taken. 2 groups will be created to apply intervention. After signing consent form, 17 patients in group A will be given costophrenic assist technique and 17 patients in group B will be given anterior chest compression technique. Baseline treatment given to both groups will include percussion and tapping. The data collected will then be analyzed using IBM SPSS version 25

Study Overview

Status

Status

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

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.

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 (Actual)

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.
34

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 Locations

  • Pakistan
    • Punjab
      • Rahim yar khan, Punjab, Pakistan, 64200
        • Sheikh Zayed Hospital,

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

Yes

Description

Inclusion Criteria:

  • Stable Patients
  • Mild to Moderate Patients of COPD according to gold criteria
  • Decreased O2 Saturation Levels
  • Immobilized Mucus

Exclusion Criteria:

  • Tachycardia
  • Tachypnea
  • Non Covid
  • Cardiovascular Pathology
  • Myopathy
  • Neurogenic Disease

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: Treatment
  • 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: Costophrenic assisted cough
While doing Costophrenic assist: at the end of expiration, the therapist gives a quick stretch to the diaphragm and intercostals to facilitate more complete inhalation by compressing the chest at the costophrenic angle toward the central tendon of the diaphragm. This is done several times to fill the lungs. The patient is then instructed to hold the air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist by applying a strong pressure up and in toward the central tendon
Other: Costophrenic assisted cough
Therapist places the hands on the costophrenic angles of the patient's rib cage. During the patient's inspiration, the therapist applies a series of three repeated quick-stretch contractions down and in to encourage maximal inspiration. At the end of expiration, the therapist applies a quick stretch down and in on the patient's lower chest to facilitate a stronger diaphragmatic and intercostal muscle contraction. While instructing the patient to cough, the therapist applies strong pressure through the hands in toward the central tendon of the patient's diaphragm
Experimental: Anterior chest compression
Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it on the lower abdomen. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion
Other: Anterior chest compression
The therapist puts one arm across the patient's pectoral region to stabilize or compress the upper chest while the other arm is placed either parallel on the lower chest or abdomen below the xiphoid process

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
Modified Borg Dyspnea (RPE) scale
Time Frame: fourth week
The most popular tool for evaluating symptoms of breathlessness is the Modified Borg Dyspnoea Scale. RPE scales, despite being a subjective gauge of exercise intensity, are useful when utilised properly. The RPE scale has a 0 to10 scale with 0 being no exertion and 10 being maximum effort
fourth week
Breathlessness, Cough and Sputum Scale (BCSS)
Time Frame: fourth week
The breathlessness, cough and sputum scale (BCSS) are a three-item scale that rates symptoms of dyspnea, cough and sputum on a Likert scale from 0 (no symptoms) to 4 (severe symptoms)
fourth week
Peak Flow Meter
Time Frame: fourth week
A peak flow meter must be used by blowing forcefully into it. In liters per minute, the meter measures the forced air flow. When you exhale, the indicator on the device moves and gives you a reading on a scale of 1 to 10. When a person's airway function changes, it may be a sign that their asthma or COPD symptoms are getting worse. This is where a peak flow meter is useful
fourth week
Pulse Oximeter:
Time Frame: fourth week
The oxygen saturation level of your blood can be measured with a non-invasive procedure called pulse oximetry. It can quickly identify even minute variations in oxygen levels. These levels demonstrate how well blood transports oxygen to your arms and legs, which are the extremities that are farthest from your heart
fourth week

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 Afzal, 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.
June 15, 2023

Primary Completion (Actual)

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.
September 15, 2023

Study Completion (Actual)

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.
December 5, 2023

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 6, 2023

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 26, 2023

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 28, 2023

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.
December 27, 2023

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.
December 26, 2023

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.
December 1, 2023

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/23/0317

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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