- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06966063
- Original Trial
Additive Effects of 4-7-8 Breathing Technique With Standard Management on Dyspnea, Pulmonary Function and Quality of Life in Patients With COPD.
A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea and reduced pulmonary function often seen in COPD patients. To handle respiratory complications COPD patients are advised to practice breathing techniques in conjunction with their prescribed medications.
Study Overview
Status
Intervention / Treatment
Detailed Description
COPD is a very common chronic respiratory disease with symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea associated with COPD. In order to manage respiratory conditions COPD patients are encouraged for nasal breathing techniques along with standard management. Hence the objective of the study is to compare the effects of 4-7-8 breathing along with standard management versus standard management alone on dyspnea, pulmonary function, and quality of life in patients with COPD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults: aged (40-64 years)
- Gender: Both males and females
- Grade1- Grade 1-3 on Modified MRC dyspnea scale
- COPD mild and moderate according to GOLD classification
- Mild: FEV1 > 80% predicted
- Moderate: FEV1 >50% predicted
Exclusion Criteria:
- Severe and very severe stage of COPD according to GOLD classification.
- Patients having Acute exacerbation of COPD.
- Patients diagnosed with acute infections.
- Patients unable to follow commands/ instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional group
Patients in interventional group will recieve 4-7-8 breathing along with standard management. For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. A home diary will be provided in order to ensure and follow-up that participants are performing breathing exercise at home along with medications prescribed by pulmonologist. |
For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. Week 01 and 02 Frequenc: 01 session/day Intensity: Start with comfortable duration. Time: 10 minutes Week 03 and 04 Frequecy: 02 sessions/day Intensity: 4 sec inhale, 7 sec hold and 8 sec exhale Time: 15 minutes |
|
Active Comparator: Control group
Patients will receive medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist. |
Patients will recieve medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea
Time Frame: 4 weeks
|
Evaluation will be done using Dyspnea-12 questionnaire for dyspnea
|
4 weeks
|
|
pulmonary function
Time Frame: 4 weeks
|
spirometer to measure volume of air inspired and exhale through lungs.
|
4 weeks
|
|
Quality of Life of COPD patients
Time Frame: 4 weeks
|
COPD assessment test (CAT) will be used to evaluate quality of life of COPD patients
|
4 weeks
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Lung Diseases, Obstructive
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Dyspnea
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- FUI/CTR/2024/69
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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