Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: FET (Forced Expiratory Technique); Other: Ba-Duan-Jin Based Deep Breathing Exercises

• Registration Number: NCT06332417
• Lead Sponsor: Riphah International University

Brief Summary

This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment.

Detailed Description

This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines). Participants should be between 40 and 55 years old. Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. All participants will continue with their prescribed medication. During this study time participants will be given instructions on how to perform the prescribed pulmonary exercises. After each exercise session the FEV1 and exercise capacity of the patients will be checked.

Study Timeline

• Study Start: 2024-02-29
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-27
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Both Genders
• Diagnosis of COPD: Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines)
• Participants should be between 40 and 55 years old
• Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment.
• Participants must be physically able to participate in Ba-Duan-Jin based deep breathing exercises.

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Exclusion Criteria

• Individuals with significant comorbidities such as asthma, pulmonary fibrosis, bronchiectasis, or lung cancer
• Participants with severe cardiovascular conditions, such as recent myocardial infarction, unstable angina, or uncontrolled hypertension, which could limit exercise participation
• Individuals with severe cognitive impairment or psychiatric conditions preventing them from understanding and following the exercise program
• Individuals with severe physical impairments unrelated to COPD, hindering their ability to perform exercises or assessments.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	FET (Forced Expiratory Technique)	FET (Forced Expiratory Technique) only
Intervention group	Ba-Duan-Jin Based Deep Breathing Exercises	Ba-Duan-Jin Exercise + FET (Forced Expiratory Technique)

Primary Outcome Measures

Name	Time	Method
36-Item Short Form Survey (SF-36)	8 Weeks	The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.; It comprises 36 questions that cover eight domains of health: 1. Limitations in physical activities because of health problems.; 2. Limitations in social activities because of physical or emotional problems; 3. Limitations in usual role activities because of physical health problems; 4. Bodily pain; 5. General mental health (psychological distress and well-being); 6. Limitations in usual role activities because of emotional problems; 7. Vitality (energy and fatigue); 8. General health perceptions Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL
Forced expiratory volume (FEV1)	8 Weeks	Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry , which is a common breathing test to check lung function.
Exercise Tolerance : 6 minute walk test	8 Weeks	a patient can quickly walk back and forth in a 30-m (100-foot) corridor in a period of 6 min, referred to as the 6-min walk distance (6MWD).
Forced vital capacity (FVC)	8 Weeks	Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry , which is a common breathing test to check lung function.
FEV1/FVC ratio	8 Weeks	The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age dependent.

Trial Locations

Locations (1)

Social Security Teaching Hospital; 🇵🇰 Lahore, Punhab, Pakistan