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Completed

NCT Number: NCT06332417

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social Security Teaching Hospital

Lahore, Punhab, 42000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ba-Duan-Jin Based Deep Breathing Exercises

Other

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)

Other

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.

Primary outcomes

  1. 36-Item Short Form Survey (SF-36)

    Time frame: 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:

    • 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

  2. FEV1/FVC ratio

    Time frame: 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.

  3. Exercise Tolerance : 6 minute walk test

    Time frame: 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).

  4. Forced vital capacity (FVC)

    Time frame: 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.

  5. Forced expiratory volume (FEV1)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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