Chronic Obstructive Pulmonary DiseaseNCT06308289
Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD
A study testing Global Posture Re-education and Active Cycle of Breathing Technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Global Posture Re-education and Active Cycle of Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2024to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-75 years diagnosed with stable COPD (according to GOLD guidelines).
- Patients of both genders
- FEV1: FVC ranging from 68 - 69%.
- Predicted FEV1 of less than 70%.
- Willingness to participate
Who cannot join
- Acute Exacerbation of COPD
- Participants with severe comorbidities, such as unstable cardiovascular diseases (e.g., recent myocardial infarction, uncontrolled hypertension)
- Participants diagnosed with respiratory conditions other than COPD (such as asthma, interstitial lung disease)
- Individuals who have undergone major thoracic or abdominal surgery within the past three months
- Individuals with severe mental health conditions (such as uncontrolled psychosis or severe depression)
- Pregnant or lactating individuals.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Global Posture Re-education, Active Cycle of Breathing Technique
- Keywords
- chronic obstructive Pulmonary disease, Posture, Work of breathing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Posture Re-educationOther
Focusing on postural correction and movement patterns
Active Cycle of Breathing TechniqueOther
Emphasizing breathing control, thoracic expansion, and mucus clearance techniques
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | GPRM and ACBT Receives: Other: Global Posture Re-education; Other: Active Cycle of Breathing Technique |
| Group B | Active comparator | Standard Care for COPD (ACBT) Receives: Other: Active Cycle of Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start3 Mar 2024
- Primary completion5 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Faizan Hamid, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308289
- Sponsor's protocol ID
- REC/RCR&AHS/23/0361
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06308289
- Acronym / sponsor ID
- REC/RCR&AHS/23/0361
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive Pulmonary disease, Posture, Work of breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Global Posture Re-education, Other: Active Cycle of Breathing TechniqueGPRM and ACBT |
| Group B | Active comparator | Other: Active Cycle of Breathing TechniqueStandard Care for COPD (ACBT) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40-75 years diagnosed with stable COPD (according to GOLD guidelines).
- Patients of both genders
- FEV1: FVC ranging from 68 - 69%.
- Predicted FEV1 of less than 70%.
- Willingness to participate
Key exclusion criteria (6 listed)
- Acute Exacerbation of COPD
- Participants with severe comorbidities, such as unstable cardiovascular diseases (e.g., recent myocardial infarction, uncontrolled hypertension)
- Participants diagnosed with respiratory conditions other than COPD (such as asthma, interstitial lung disease)
- Individuals who have undergone major thoracic or abdominal surgery within the past three months
- Individuals with severe mental health conditions (such as uncontrolled psychosis or severe depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Posture Re-educationFocusing on postural correction and movement patterns | Other | Group A |
| Active Cycle of Breathing TechniqueEmphasizing breathing control, thoracic expansion, and mucus clearance techniques | Other | Group A, Group B |
Primary outcome
SF- 36 Questionnaire
Time frame: 12 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: 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
FEV1/FVC ratio
Time frame: 12 Weeks
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.
6-minute walk test
Time frame: 12 Weeks
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.
Photogrammetry
Time frame: 12 Weeks
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.
Forced expiratory volume (FEV1)
Time frame: 12 Weeks
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.
Forced vital capacity (FVC)
Time frame: 12 Weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Faizan Hamid, MS-CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Posture Re-education and Active Cycle of Breathing Technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF- 36 Questionnaire (time frame: 12 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.