Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients

April 18, 2024 updated by: Riphah International University

Effects of Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients

Chronic Obstructive Pulmonary Disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. The symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. Due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. Patient will also feel breathless just sitting or relaxing. Active Cycle of breathing technique can be used to mobilize and clear secretions. It will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. Acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. A randomized control trial will be conducted at Gosha e Shifa hospital and General hospital Lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with active cycle of breathing exercises/techniques and Group B will be treated with Acapella device with active cycle of breathing exercise .Outcome measure will be conducted through Modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform Pulmonary function test .Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of COPD.

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.
42

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
        • 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

No

Description

Inclusion Criteria:

  • Both men and women age between 35-50 years.
  • Having smoking history .(1)
  • Dyspnea MRC scale grade 2 and grade 3.(20)
  • Gold standard COPD grade 2

Exclusion Criteria:

  • Any kind of infective pulmonary condition .
  • Restrictive lung disease.(20)
  • Pregnancy.
  • Any severe heart 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.
Active Comparator: Active cycle of breathing technique
ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique.
Other: Active Cycle of breathing
Active Cycle of Breathing Techniques will be given to group A. In Active cycle of breathing exercises, breathing control, thoracic expansion and forced expiration technique will be applied. 3-4 sets of exercise ,10-15 mint, 4 times per week for 4 weeks.
Experimental: Active Cycle of breathing with Acapela
ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. The Acapella device is a handheld device used to help loosen mucus in the lungs. Sit up straight and hold the device in the upright position. Take a deep breath in and seal lips around the mouthpiece. Exhaleforcefully through the mouthpiece, using your stomach muscles to push the air out. Repeat this process several times, taking breaks. After using Acapella cough to clear any mucus that has been loosened. Clean the device after each use.
Other: Active Cycle of breathing
Active Cycle of Breathing Techniques will be given to group A. In Active cycle of breathing exercises, breathing control, thoracic expansion and forced expiration technique will be applied. 3-4 sets of exercise ,10-15 mint, 4 times per week for 4 weeks.
Other: Active Cycle of breathing with Acapella

Acapella device will be used along active cycle of breathing techniques to group B. 3-4 sets ,10 mints foe acapella training ,15 -20 munts ,4 times per week for 4 weeks.

This technique is active form of therapy in which patient uses its own energy on request to aid in treatment.

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 Dyspnea scale.
Time Frame: baseline and fourth week
Data collection tool for shortness of breath is modified dyspnea scale there will be 10 readings. It also accesses breathing discomfort, sensory qualities and emotional distress.
baseline and fourth week
PFTs
Time Frame: baseline and fourth week
The test will measure the lung volume, and ABGs. It is important tool for the investigation and monitoring of patients with respiratory pathology
baseline and fourth week
Sputum diary BCSS
Time Frame: baseline and fourth week
In this diary we will check breathlessness, cough and sputum. It also includes the score of patient wellbeing and documented all minor symptoms
baseline and 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: Madiha Younis, MSPT (CP), 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.
February 15, 2024

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.
March 15, 2024

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.
April 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).
January 28, 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.
January 28, 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.
February 5, 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.
April 19, 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.
April 18, 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.
April 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/23/0339

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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