Clinical trial NCT05922254: Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease
Official title: Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive
Drainage
Postural
Pulmonary Disease
Respiratory Therapy.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Borg Dyspnea (RPE) scale
timeFrame: fourth week
measure: Dyspnea Index Questionnaire
timeFrame: fourth week
measure: Breathlessness, Cough and Sputum Scale (BCSS)
timeFrame: fourth week
measure: Fatigue Severity Scale
timeFrame: fourth week
measure: Peak Flow meter
timeFrame: baseline and fourth week
measure: Oximeter
timeFrame: fourth week
Secondary outcomes:
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Sheikh Zayed Hospital,
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Afzal, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.