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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06332417
Other study ID # REC/RCR&AHS/23/0364
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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