- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06463288
Comparison of Jacobson Relaxation Technique and Pranayama Technique in Patients With COPD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus production and wheezing. Its typically caused by long term exposure to irritating gasses or particulate matter, most often from cigarette smoker. in this study we compare the effect of Jacobson relaxation technique and Pranayama technique on the SOB, Cough, sputum and quality of life in COPD patients.
Data were collected from Gulab Devi Chest Hospital, General Hospital, Jinnah Hospital and Mayo Hospital Lahore. Data were collected by the lottery method. Borg dyspnea scale, Spirometry, CASA-Q and Quality of life questionnaire were used before and after the intervention. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Gulab Devi Chest Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients of Age between 40 and 70.
- Both Genders (Male, Female) were included.
- Stage 2 patient with COPD with Dyspnea FEV1 <70% and Maximal Expiratory Pressure = 50% (Gold Criteria) were included.
- Cognitive Stable patients were included.
- Those Patients were included who were clinically stable without exacerbations in the past 01 month.
Exclusion Criteria:
• Common Cough
- Upper respiratory tract inflammation
- Patients who have other co-morbid diseases which prevents them from exercise training, for example, disability due to neurological, orthopedic and acute cardiac causes
- Patients who were mentally and physically and sick to join at the hospital or research site for training
- Patients who were already participated or completed or in a P.R program in the past one year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Jacobson's Technique
Participant in the group A were instructed to perform the Jacobson relaxation technique.
|
Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.
|
|
Active Comparator: Pranayama Technique
Participant in group B were instructed to perform the pranayama relaxation technique.
Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment. |
Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Severity (Borg Scale)
Time Frame: 4 weeks
|
The Borg scale measures the severity of dyspnea (shortness of breath). Scale Details: Full Title: Borg Rating of Perceived Exertion (RPE) ScaleFull Title: Borg Rating of Perceived Exertion (RPE) Scale Minimum Value: 0 (No breathlessness at all) Maximum Value: 10 (Maximal breathlessness) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of dyspnea. |
4 weeks
|
|
Cough and Sputum Analysis (CASA-Q)
Time Frame: 4 Weeks
|
The CASA-Q (Cough and Sputum Assessment Questionnaire) evaluates the severity and impact of cough and sputum production. Scale Details: Full Title: Cough and Sputum Assessment Questionnaire (CASA-Q) Minimum Value: 0 (No symptoms) Maximum Value: 100 (Severe symptoms) Interpretation: Higher scores indicate worse outcomes, meaning more severe symptoms of cough and sputum. |
4 Weeks
|
|
Spirometry (FEV1 and FVC)
Time Frame: 4 Weeks
|
Spirometry will be used to measure lung function, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC). Scale Details: Full Title: Spirometry (FEV1 and FVC) Minimum Value: Variable (dependent on patient's lung function) Maximum Value: Variable (dependent on patient's lung function) Interpretation: Higher values typically indicate better lung function. |
4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (SF-36 Questionnaire)
Time Frame: 4 Weeks
|
The SF-36 (Short Form Health Survey) questionnaire assesses the overall quality of life. Scale Details: Full Title: SF-36 Health Survey Minimum Value: 0 (Worst possible health state) Maximum Value: 100 (Best possible health state) Interpretation: Higher scores indicate better quality of life. |
4 Weeks
|
|
Patient Satisfaction (Patient Satisfaction Questionnaire)
Time Frame: 4 Weeks
|
The Patient Satisfaction Questionnaire measures the satisfaction of patients with the treatment they received. Full Title: Patient Satisfaction Questionnaire (PSQ) Minimum Value: 1 (Very dissatisfied) Maximum Value: 5 (Very satisfied) Interpretation: Higher scores indicate greater satisfaction. |
4 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sumera Hameed, MS, Riphah International University
Publications and helpful links
General Publications
- Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
- Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. No abstract available.
- Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
- Ozgundondu B, Gok Metin Z. Effects of progressive muscle relaxation combined with music on stress, fatigue, and coping styles among intensive care nurses. Intensive Crit Care Nurs. 2019 Oct;54:54-63. doi: 10.1016/j.iccn.2019.07.007. Epub 2019 Jul 29.
- Ranjita R, Hankey A, Nagendra HR, Mohanty S. Yoga-based pulmonary rehabilitation for the management of dyspnea in coal miners with chronic obstructive pulmonary disease: A randomized controlled trial. J Ayurveda Integr Med. 2016 Jul-Sep;7(3):158-166. doi: 10.1016/j.jaim.2015.12.001. Epub 2016 Aug 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/ 31831 Iqra
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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