Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
Verified date | December 2023 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Sheikh Zayed Hospital, | Rahim Yar Khan | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
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
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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