- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240936
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
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
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
Investigators
- 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
- Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
- Anto JM, Vermeire P, Vestbo J, Sunyer J. Epidemiology of chronic obstructive pulmonary disease. Eur Respir J. 2001 May;17(5):982-94. doi: 10.1183/09031936.01.17509820.
- Lange P, Ahmed E, Lahmar ZM, Martinez FJ, Bourdin A. Natural history and mechanisms of COPD. Respirology. 2021 Apr;26(4):298-321. doi: 10.1111/resp.14007. Epub 2021 Jan 28.
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)
February 15, 2024
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
January 28, 2024
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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