NCT05922267

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

June 6, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

COPD(chronic obstructive pulmonary disease),ACBT(active cycle of breathing techniques)ELTGOL

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Active cycle of breathing technique

EXPERIMENTAL

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

Other: ACTIVE CYCLE OF BREATHING TECHNIQUES

SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION

EXPERIMENTAL

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

Other: SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION

Interventions

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

Active cycle of breathing technique

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

SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders (Male and Female)
  • years
  • Diagnosed COPD according to GOLD classification
  • Hemodynamically stable patient

You may not qualify if:

  • Patient with other disorders like cardiac and respiratory disorders
  • Carcinoma
  • Lung surgery
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 34821191BACKGROUND
  • 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.

    PMID: 33682534BACKGROUND
  • 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.

    PMID: 35235877BACKGROUND
  • 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.

    PMID: 29326318BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 28, 2023

Study Start

June 15, 2023

Primary Completion

September 15, 2023

Study Completion

December 5, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations