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

NCT06332417 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0364
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary disease; Breathing Exercises; Ba-Duan Jin

Outcome Measures

Primary Outcomes (5)

• 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: 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

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

Ba-Duan-Jin Exercise + FET (Forced Expiratory Technique)

Other: Ba-Duan-Jin Based Deep Breathing Exercises

Control Group

ACTIVE COMPARATOR

FET (Forced Expiratory Technique) only

Other: FET (Forced Expiratory Technique)

Interventions

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.

Intervention group

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.

Control Group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Social Security Teaching Hospital

Lahore, Punhab, 42000, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Faizan Hamid, MS-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 27, 2024
• Study Start: February 29, 2024
• Primary Completion: June 5, 2024
• Study Completion: June 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)