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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05922267
Other study ID # REC/RCR&AHS/23/0321
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date December 5, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life .Therefore, Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable for every patient to reduce condition . The effect of ELTGOL on mucus clearance of right and left lungs, especially of peripheral lung areas, in stable patients with COPD . A couple of relaxed breaths and when you are ready go on to your huff. Repeat the huff two or three times until you have the urge to cough. Once you have cleared your chest have a few normal relaxed breaths and start the cycle over again with deep breaths and huffs. A Randomized clinical trial, subjects with age group between 4O-70 years. In Group -A subjects (n=15) were treated with Active Cycle of Breathing Technique where Group-B subjects (n=15) received ELTGOL training . This study is to compare the effectiveness of ACBT and ELTGOL on improving the Quality Of Life and increasing Functional Capacity in subjects with COPD . Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 5, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Both genders (Male and Female) - 40-70 years - Diagnosed COPD according to GOLD classification - Hemodynamically stable patient Exclusion Criteria: - Patient with other disorders like cardiac and respiratory disorders - Carcinoma - Lung surgery - Neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ACTIVE CYCLE OF BREATHING TECHNIQUES
The participants in group A will be given ACBT with conventional chest physiotherapy . Instruction for patient Try to keep your chest Take a long, slow and deep breath in, through your nose if you can. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing Breathe out gently and relaxed, like a sigh. Don't force the air out. Repeat 3 - 5 times. If the patient feels light-headed then it is important that they revert back to the breathing control phase of the cycle Huffing
SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
The participants in group B will be given slow expiration with open glottis in lateral posture and conventional chest physiotherapy .In this technique, a patient adopts a lateral posture or a lateral decubitus posture. The affected lung is in the dependent position. A patient commences breathing normally, at tidal volumes. They are then instructed to perform a series of slow expirations with an open glottis. Expiration from functional residual capacity to the end of the expiratory reserve volume are encouraged to achieve maximum inflation . To assist in maintaining an open glottis, a mouthpiece may be used, to decrease the degree of airway compression A series of three ELTGOL may be performed, with each series composed of approximately 10 slow and deep expirations. In between each series of maneuvers, a rest period (around 1-2 minutes) is provided, with the patient staying in the same position. A typical treatment lasts for around 20 minutes

Locations

Country Name City State
Pakistan Mayo Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Fei F, Koffman J, Zhang X, Gao W. Chronic Obstructive Pulmonary Disease Symptom Cluster Composition, Associated Factors, and Methodologies: A Systematic Review. West J Nurs Res. 2022 Apr;44(4):395-415. doi: 10.1177/0193945921995773. Epub 2021 Mar 6. — View Citation

Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan. — View Citation

Papaporfyriou A, Bakakos P, Hillas G, Papaioannou AI, Loukides S. Blood eosinophils in COPD: friend or foe? Expert Rev Respir Med. 2022 Jan;16(1):35-41. doi: 10.1080/17476348.2021.2011219. Epub 2021 Dec 3. — View Citation

Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dyspnea scale to assess change in pre and post Medical Research Council (MRC) chronic dyspnea scale, used for the estimation of disability due to dyspnea, may serve as a simple index of disease severity and extent in patients with lung disease. This scale consists of six questions about perceived breathlessness: category 0, no dyspnea; category 1, slight degree of dyspnea (troubled by shortness of breath when hurrying on the level or walking up a slight hill); category 2, moderate degree of dyspnea (walks slower than people of the same age on the level because of breathlessness); category 3, moderately severe degree of dyspnea (has to stop because of breathlessness when walking at own pace on the level); category 4, severe degree of dyspnea (stops for breath after walking about 100 yards or after a few minutes on the level); category 5, very severe degree of dyspnea (too breathless to leave the house or breathless when dressing or undressing base line and fourth week
Primary Peak Flow Meter to assess change in pre and post Peak flow meter is mini spirometer which measures the PEFR .The Peak Expiratory Flow Rate (PEFR) is the maximum or peak flow rate that is attained during a forceful expiratory effort after taking a deep inspiration .Its normal range is 250 to 400 . The Peak Expiratory Flow Rate (PEFR) is the maximum or peak flow rate that is attained during a forceful expiratory effort after taking a deep inspiration baseline and fourth week
Primary BCSS to assess change In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness baseline and fourth week
Primary Oximeter to assess change A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen baseline and fourth week
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