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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Ba-Duan-Jin Based Deep Breathing Exercises; Other: FET (Forced Expiratory Technique)

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: +923324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punhab
    • Lahore, Punhab, Pakistan, 42000
      • Recruiting
      • Social Security Teaching Hospital
      • Contact: Faisal Rehman, MBBS; Phone Number: +924299230227; Email: info@pessi.punjab.gov.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Ba-Duan-Jin Exercise + FET (Forced Expiratory Technique)	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.
Active Comparator: Control Group; FET (Forced Expiratory Technique) only	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Faizan Hamid, Ms-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): June 5, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Breathing Exercises; Pulmonary disease; Ba-Duan Jin
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REC/RCR&AHS/23/0364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No