COPDNCT06463288
Comparison of Jacobson Relaxation Technique and Pranayama Technique in Patients With COPD
A study testing Jacobsons Breathing Technique and Pranayama Technique in people with COPD and Shortness of Breath, run by Riphah International University at 1 site in Pakistan.
Trial summary
Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD, Shortness of Breath, Quality of Life
- What is being tested?
- Jacobsons Breathing Technique and Pranayama Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2023to 10 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients of Age between 40 and 70.
- Both Genders (Male, Female) were included.
- Stage 2 patient with COPD with Dyspnea FEV1 <70% and Maximal Expiratory Pressure = 50% (Gold Criteria) were included.
- Cognitive Stable patients were included.
- Those Patients were included who were clinically stable without exacerbations in the past 01 month.
Who cannot join
- • Common Cough
- Upper respiratory tract inflammation
- Patients who have other co-morbid diseases which prevents them from exercise training, for example, disability due to neurological, orthopedic and acute cardiac causes
- Patients who were mentally and physically and sick to join at the hospital or research site for training
- Patients who were already participated or completed or in a P.R program in the past one year.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD
Read the detailed description
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus production and wheezing. Its typically caused by long term exposure to irritating gasses or particulate matter, most often from cigarette smoker. in this study we compare the effect of Jacobson relaxation technique and Pranayama technique on the SOB, Cough, sputum and quality of life in COPD patients.
Data were collected from Gulab Devi Chest Hospital, General Hospital, Jinnah Hospital and Mayo Hospital Lahore. Data were collected by the lottery method. Borg dyspnea scale, Spirometry, CASA-Q and Quality of life questionnaire were used before and after the intervention. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment.
- Conditions
- COPD, Shortness of Breath, Quality of Life, Cough
- Being tested
- Jacobsons Breathing Technique, Pranayama Technique
- Keywords
- COPD, Jacobson Technique, Pranayama Technique, SOB
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jacobsons Breathing TechniqueProcedure or surgery
Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.
Pranayama TechniqueProcedure or surgery
Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.
| Study group | Role | What they receive |
|---|---|---|
| Jacobson's Technique | Experimental | Participant in the group A were instructed to perform the Jacobson relaxation technique.
* Quite place were chosen where there is no disturbance.
* Patients were relax either on the lying position or sitting position with head well-supported.
* Patients were instructed to loosen any tight clothing.
* Patients were educated for muscles of each group emphasis on attention on that muscle group only.
* Repeat this three times, constrict the muscle and then relax, tens the muscle and maintain it for five seconds then relax it lightly and then tense and relax. Constrict the muscle very slightly then relax it. Focus on each muscle group and then decide to relax the target muscle. Receives: Procedure: Jacobsons Breathing Technique |
| Pranayama Technique | Active comparator | Participant in group B were instructed to perform the pranayama relaxation technique.
* Quite place were chosen where there is no disturbance and patient were relaxed in sitting position with spine straight.
* In this technique patients were instructed to perform different type of pranayama techniques.
* Guide the participants to take a steady breath in through your both nostrils. Then inhale until you reach your total lung capacity, maintaining a tall spine.
Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment. Receives: Procedure: Pranayama Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Severity (Borg Scale)
The Borg scale measures the severity of dyspnea (shortness of breath).
Scale Details:
Full Title: Borg Rating of Perceived Exertion (RPE) ScaleFull Title: Borg Rating of Perceived Exertion (RPE) Scale Minimum Value: 0 (No breathlessness at all) Maximum Value: 10 (Maximal breathlessness) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of dyspnea.
Measured: 4 weeks
Cough and Sputum Analysis (CASA-Q)
The CASA-Q (Cough and Sputum Assessment Questionnaire) evaluates the severity and impact of cough and sputum production.
Scale Details:
Full Title: Cough and Sputum Assessment Questionnaire (CASA-Q) Minimum Value: 0 (No symptoms) Maximum Value: 100 (Severe symptoms) Interpretation: Higher scores indicate worse outcomes, meaning more severe symptoms of cough and sputum.
Measured: 4 Weeks
Spirometry (FEV1 and FVC)
Spirometry will be used to measure lung function, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC).
Scale Details:
Full Title: Spirometry (FEV1 and FVC) Minimum Value: Variable (dependent on patient's lung function) Maximum Value: Variable (dependent on patient's lung function) Interpretation: Higher values typically indicate better lung function.
Measured: 4 Weeks
Secondary outcomes (2)
Quality of Life (SF-36 Questionnaire)
The SF-36 (Short Form Health Survey) questionnaire assesses the overall quality of life.
Scale Details:
Full Title: SF-36 Health Survey Minimum Value: 0 (Worst possible health state) Maximum Value: 100 (Best possible health state) Interpretation: Higher scores indicate better quality of life.
Measured: 4 Weeks
Patient Satisfaction (Patient Satisfaction Questionnaire)
The Patient Satisfaction Questionnaire measures the satisfaction of patients with the treatment they received.
Full Title: Patient Satisfaction Questionnaire (PSQ) Minimum Value: 1 (Very dissatisfied) Maximum Value: 5 (Very satisfied) Interpretation: Higher scores indicate greater satisfaction.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start20 Jul 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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 Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Hameed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463288
- Sponsor's protocol ID
- REC/ 31831 Iqra
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. No abstract available.
PubMed 11463370Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
PubMed 18046898Ozgundondu B, Gok Metin Z. Effects of progressive muscle relaxation combined with music on stress, fatigue, and coping styles among intensive care nurses. Intensive Crit Care Nurs. 2019 Oct;54:54-63. doi: 10.1016/j.iccn.2019.07.007. Epub 2019 Jul 29.
PubMed 31371164Ranjita R, Hankey A, Nagendra HR, Mohanty S. Yoga-based pulmonary rehabilitation for the management of dyspnea in coal miners with chronic obstructive pulmonary disease: A randomized controlled trial. J Ayurveda Integr Med. 2016 Jul-Sep;7(3):158-166. doi: 10.1016/j.jaim.2015.12.001. Epub 2016 Aug 18.
PubMed 27545747Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
PubMed 15955148
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Jacobson Relaxation Technique and Pranayama Technique in Patients With COPD
- ClinicalTrials.gov ID
- NCT06463288
- Acronym / sponsor ID
- REC/ 31831 Iqra
- Conditions
- COPD, Shortness of Breath, Quality of Life, Cough
- Keywords
- COPD, Jacobson Technique, Pranayama Technique, SOB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 17 Jun 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.
Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD
Detailed description
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus production and wheezing. Its typically caused by long term exposure to irritating gasses or particulate matter, most often from cigarette smoker. in this study we compare the effect of Jacobson relaxation technique and Pranayama technique on the SOB, Cough, sputum and quality of life in COPD patients.
Data were collected from Gulab Devi Chest Hospital, General Hospital, Jinnah Hospital and Mayo Hospital Lahore. Data were collected by the lottery method. Borg dyspnea scale, Spirometry, CASA-Q and Quality of life questionnaire were used before and after the intervention. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Jacobson's Technique | Experimental | Procedure: Jacobsons Breathing TechniqueParticipant in the group A were instructed to perform the Jacobson relaxation technique. * Quite place were chosen where there is no disturbance. * Patients were relax either on the lying position or sitting position with head well-supported. * Patients were instructed to loosen any tight clothing. * Patients were educated for muscles of each group emphasis on attention on that muscle group only. * Repeat this three times, constrict the muscle and then relax, tens the muscle and maintain it for five seconds then relax it lightly and then tense and relax. Constrict the muscle very slightly then relax it. Focus on each muscle group and then decide to relax the target muscle. |
| Pranayama Technique | Active comparator | Procedure: Pranayama TechniqueParticipant in group B were instructed to perform the pranayama relaxation technique. * Quite place were chosen where there is no disturbance and patient were relaxed in sitting position with spine straight. * In this technique patients were instructed to perform different type of pranayama techniques. * Guide the participants to take a steady breath in through your both nostrils. Then inhale until you reach your total lung capacity, maintaining a tall spine. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients of Age between 40 and 70.
Key exclusion criteria (5 listed)
- • Common Cough
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 |
|---|---|---|
| Jacobsons Breathing TechniqueQuality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed. | Procedure or surgery | Jacobson's Technique |
| Pranayama TechniqueQuality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed. | Procedure or surgery | Pranayama Technique |
Primary outcome
Dyspnea Severity (Borg Scale)
Time frame: 4 weeks
The Borg scale measures the severity of dyspnea (shortness of breath). Scale Details: Full Title: Borg Rating of Perceived Exertion (RPE) ScaleFull Title: Borg Rating of Perceived Exertion (RPE) Scale Minimum Value: 0 (No breathlessness at all) Maximum Value: 10 (Maximal breathlessness) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of dyspnea.
Cough and Sputum Analysis (CASA-Q)
Time frame: 4 Weeks
The CASA-Q (Cough and Sputum Assessment Questionnaire) evaluates the severity and impact of cough and sputum production. Scale Details: Full Title: Cough and Sputum Assessment Questionnaire (CASA-Q) Minimum Value: 0 (No symptoms) Maximum Value: 100 (Severe symptoms) Interpretation: Higher scores indicate worse outcomes, meaning more severe symptoms of cough and sputum.
Spirometry (FEV1 and FVC)
Time frame: 4 Weeks
Spirometry will be used to measure lung function, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC). Scale Details: Full Title: Spirometry (FEV1 and FVC) Minimum Value: Variable (dependent on patient's lung function) Maximum Value: Variable (dependent on patient's lung function) Interpretation: Higher values typically indicate better lung function.
2 secondary outcomes
Quality of Life (SF-36 Questionnaire)
Time frame: 4 Weeks
Patient Satisfaction (Patient Satisfaction Questionnaire)
Time frame: 4 Weeks
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 17 Jun 2024.
- Background: PubMed 11463370Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. No abstract available.
- Background: PubMed 18046898Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
- Background: PubMed 31371164Ozgundondu B, Gok Metin Z. Effects of progressive muscle relaxation combined with music on stress, fatigue, and coping styles among intensive care nurses. Intensive Crit Care Nurs. 2019 Oct;54:54-63. doi: 10.1016/j.iccn.2019.07.007. Epub 2019 Jul 29.
- Background: PubMed 27545747Ranjita R, Hankey A, Nagendra HR, Mohanty S. Yoga-based pulmonary rehabilitation for the management of dyspnea in coal miners with chronic obstructive pulmonary disease: A randomized controlled trial. J Ayurveda Integr Med. 2016 Jul-Sep;7(3):158-166. doi: 10.1016/j.jaim.2015.12.001. Epub 2016 Aug 18.
- Background: PubMed 15955148Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
- 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.
Sumera Hameed, MS 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 Jacobsons Breathing Technique and Pranayama Technique in people with COPD and Shortness of Breath, 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 5 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 17 Jun 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?
Dyspnea Severity (Borg Scale) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463288, which also lists 5 linked publications.
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 17 Jun 2024.