Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique on Cardiorespiratory Fitness, Posture and Quality of Life in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308289
• Other study ID #: REC/RCR&AHS/23/0361
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms.

Description:

The focus of this study will be on addressing the critical challenge of treating chronic obstructive pulmonary disease (COPD), a globally prevalent and heterogeneous lung condition associated with substantial morbidity and mortality. With COPD anticipated to become the leading global cause of death, this research will investigate a novel intervention that combines global postural retraining (GPRM) and physical fitness, utilizing respiratory cycle technology (ACBT). This study assumes to enhance heart rate, posture, and overall quality of life in individuals with COPD. The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only. The study, utilizing nonprobability purposive sampling, will span six months to comprehensively evaluate cardiovascular, respiratory, and quality-of-life outcomes. Exclusion criteria ensure a representative sample, excluding individuals with severe diseases or recent surgeries. The significance of this investigation lies in its potential to revolutionize COPD treatment, offering a cost-effective approach that simultaneously enhances patient health. By targeting both biomechanical and respiratory aspects, the study aims to provide valuable insights into improving COPD treatment strategies globally, with a focus on the combined effects of global postural retraining and active breathing techniques. Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms.

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 75 Years

Eligibility

Inclusion Criteria:

1. Adults aged 40-75 years diagnosed with stable COPD (according to GOLD guidelines).

2. Patients of both genders

3. FEV1: FVC ranging from 68 - 69%.

4. Predicted FEV1 of less than 70%.

5. Willingness to participate

Exclusion Criteria:

1. Acute Exacerbation of COPD

2. Participants with severe comorbidities, such as unstable cardiovascular diseases (e.g., recent myocardial infarction, uncontrolled hypertension)

3. Participants diagnosed with respiratory conditions other than COPD (such as asthma, interstitial lung disease)

4. Individuals who have undergone major thoracic or abdominal surgery within the past three months

5. Individuals with severe mental health conditions (such as uncontrolled psychosis or severe depression)

6. Pregnant or lactating individuals.

Related Conditions & MeSH terms

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

Intervention

Other:
• Global Posture Re-education
Focusing on postural correction and movement patterns
• Active Cycle of Breathing Technique
Emphasizing breathing control, thoracic expansion, and mucus clearance techniques

Locations

Country	Name	City	State
Pakistan	Social Security Hospital	Gujranwala	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF- 36 Questionnaire	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	12 Weeks
Primary	FEV1/FVC ratio	The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.	12 Weeks
Primary	6-minute walk test	The Six-Minute Walk Test (6MWT) assesses exercise capacity. Participants are briefed and baseline vital signs are recorded.; The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	12 Weeks
Primary	Photogrammetry	Photogrammetry is a research tool used in COPD studies to assess physical changes. It involves capturing and analyzing images of patients to measure anatomical features and body movement.	12 Weeks
Primary	Forced expiratory volume (FEV1)	The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.	12 Weeks
Primary	Forced vital capacity (FVC)	The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.	12 Weeks