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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332417
• Other study ID #: REC/RCR&AHS/23/0364
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: +923324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 15, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Ba-Duan-Jin Based Deep Breathing Exercises
Pressing Up to the Heavens: Deep inhales while raising arms, promoting lung expansion. Drawing the Bow to Shoot the Eagle: Stretching exercises to improve flexibility and posture.
• FET (Forced Expiratory Technique)
The forced expiratory technique sometimes referred to as a 'huff', is used to help force secretions (phlegm) up the throat so it can be removed via the mouth without the pain of coughing.

Locations

Country	Name	City	State
Pakistan	Social Security Teaching Hospital	Lahore	Punhab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	36-Item Short Form Survey (SF-36)	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: Limitations in physical activities because of health problems.; Limitations in social activities because of physical or emotional problems; Limitations in usual role activities because of physical health problems; Bodily pain; General mental health (psychological distress and well-being); Limitations in usual role activities because of emotional problems; Vitality (energy and fatigue); 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	8 Weeks
Primary	FEV1/FVC ratio	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.	8 Weeks
Primary	Exercise Tolerance : 6 minute walk test	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).	8 Weeks
Primary	Forced vital capacity (FVC)	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.	8 Weeks
Primary	Forced expiratory volume (FEV1)	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.	8 Weeks