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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05922254
Other study ID # REC/RCR&AHS/23/0318
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

A randomised controlled trial will be conducted with COPD patients as its target population. There will be 40 individuals for both the control group and the intervention group. Group A is a control group while Group B is an experimental group (20 participants on Group A and 20 on group B). The baseline treatment for both groups were pursed lip breathing and ACBT. On the other hand, group B experimental group will also undergo (pursued lip breathing and ACBT) with autogenic drainage. Group A session lasts for 30 minutes and Group B session lasts for 45 minutes. There is only one session per day. There is a three session in a week for 4 weeks. Measurements are made of dyspnea, oxygen saturation, peak expiratory flow rate, pulse rate and fatigue both before and after the treatment, data were recorded. Participants in the trial must have mild to moderate COPD (GOLD Criteria) and be between the ages of 40 to 60 years. Data from Sheikh Zayed Hospital, Rahim Yar Khan will be collected. Follow-up for both completed tasks and changes in pulmonary status will be evaluated after 4 weeks. Modified Borg Dyspnea (RPE) Scale, Breathlessness, Cough and Sputum Scale (BCSS), Fatigue Severity Scale or Visual Analogue Scale, Peak flow meter, Oximeter will be used to measure the outcomes. Data will be analysed using the SPSS 21.0 Statistical Software


Description:

The term "COPD" refers to a range of illnesses that impair breathing and obstruct airflow. Smoking or having smoked in the past increases the risk of developing COPD because tobacco smoke is the primary cause of the disease. The risk is further increased by family history, occupational or home, air pollution exposure and respiratory illnesses including pneumonia. The signs and symptoms include wheezing, coughing up mucus (sputum) and difficulty in breathing. It is frequently brought on by prolonged exposure to irritant gases or particulates most frequently from cigarette smoke. Heart disease, lung cancer and a number of other diseases are more likely to occur in people with COPD. A randomised controlled trial will be conducted with COPD patients as its target population. There will be 40 individuals for both the control group and the intervention group. Group A is a control group while Group B is an experimental group (20 participants on Group A and 20 on group B). The baseline treatment for both groups were pursed lip breathing and ACBT. On the other hand, group B experimental group will also undergo (pursued lip breathing and ACBT) with autogenic drainage. Group A session lasts for 30 minutes and Group B session lasts for 45 minutes. There is only one session per day. There is a three session in a week for 4 weeks. Measurements are made of dyspnea, oxygen saturation, peak expiratory flow rate, pulse rate and fatigue both before and after the treatment, data were recorded. Participants in the trial must have mild to moderate COPD (GOLD Criteria) and be between the ages of 40 to 60 years. Data from Sheikh Zayed Hospital, Rahim Yar Khan will be collected. Follow-up for both completed tasks and changes in pulmonary status will be evaluated after 4 weeks. Modified Borg Dyspnea (RPE) Scale, Breathlessness, Cough and Sputum Scale (BCSS), Fatigue Severity Scale or Visual Analogue Scale, Peak flow meter, Oximeter will be used to measure the outcomes. Data will be analysed using the SPSS 21.0 Statistical Software.


Recruitment information / eligibility

Status Completed
Enrollment 40
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 60 Years
Eligibility Inclusion Criteria: - Both genders (Male and Female) - Age 40 to 60 years - Mild to moderate COPD (According to GOLD Criteria) - Patient is bilingual. Exclusion Criteria: - Patients having progressive respiratory muscle weakness (Mysthenia Gravis) - Cardiovascular impairment - Any recent surgery - Systemic illness - Angina - Uncontrolled diabetes and hypertension - TB - Non-cooperative Patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active cycle of breathing technique
The ACBT technique consists of three different breathing techniques: breathing control, thoracic expansion exercises and forced expiration technique. 1. Breathing Control 2. Thoracic Expansion Exercises: 3. Forced Expiration Technique:
Autogenic drainage
Huffing or blowing the nose helped to get rid of any secretions in the upper airways. The therapist was placed close enough to hear the subject's breathing while sitting to the side and slightly behind the patient. Both the physiotherapist's hand and the subject's hands were put on the subject's abdomen to feel the activity of the abdominal muscles. The patient inhaled slowly through the nose while using their diaphragm and holding their breath for two to three seconds to allow collateral ventilation to bring air behind their secretions. Exhalation was done through the mouth. The palm of the therapist placed on the upper chest felt the vibration of the mucous. Their positions were disclosed by the vibrations' frequency.

Locations

Country Name City State
Pakistan Sheikh Zayed Hospital, Rahim Yar Khan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31. — View Citation

Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28. — View Citation

Yadav UN, Lloyd J, Hosseinzadeh H, Baral KP, Harris MF. Do Chronic Obstructive Pulmonary Diseases (COPD) Self-Management Interventions Consider Health Literacy and Patient Activation? A Systematic Review. J Clin Med. 2020 Feb 28;9(3):646. doi: 10.3390/jcm9030646. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Borg Dyspnea (RPE) scale 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
Primary Dyspnea Index Questionnaire The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients. It includes 10-item surveys fourth week
Primary Breathlessness, Cough and Sputum Scale (BCSS) 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). The Breathlessness, Cough and Sputum Scale (BCSS), which assesses common symptoms found in the COPD population, is used to predict patient exacerbations fourth week
Primary Fatigue Severity Scale You can assess the impact of fatigue on you using the Fatigue Severity Scale (FSS). The FSS is a brief questionnaire that asks you to rate how tired you are. Nine statements in the FSS questionnaire allow you to express how severe your tiredness symptoms are fourth week
Primary Peak Flow meter 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 baseline and fourth week
Primary Oximeter 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. It looks like a little clip and is called a pulse oximeter. It attaches to a body component, usually a finger fourth week
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