Chronic SmokersNCT06537479
Combined Effects of Buteyko Breathing Technique and Chest Wall Mobilization on Pulmonary Functions and Quality of Life
A study testing Buteyko breathing technique and Chest Wall Mobilization in people with Chronic Smokers, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Chronic Smokers
- What is being tested?
- Buteyko breathing technique and Chest Wall Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2024to 10 Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female participants were included
- The age of participants was 40 -55 years.
- Individuals who fulfilled the criteria of smoking which is calculated by multiplying the number of packs smoked per day by the number of years smoked were included.
- Individuals who are current smokers or history of long-term smoking were included.
- Predicted values FEV1 < 75% and FEV1/FVC <70%
Who cannot join
- Participants with neurological disorders were excluded
- Participants with musculoskeletal disorders were excluded as it affects the physical activity of the 6-minute walk test.
- Participants having any pulmonary complications or lung disease were excluded.
- Participants previously involved in any other exercise or physical activity were excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
Samia Sarmad, PHD, 03004813195, info@hospital.uol.edu.pk
Jawad, MS-NMPT, 03124047465, info@hospital.uol.edu.pk
About this study
Official title: Combined Effects of Buteyko Breathing Technique and Chest Wall Mobilization on Pulmonary Functions and Quality of Life in Chronic Smokers
The study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS \& AHS. A non-probability convenient sampling technique will be used to recruit the individuals. Group 1-Buteyko breathing technique + Chest Wall Mobilization and Group 2-Buteyko Breathing Technique + Without Chest Wall Mobilization
Read the detailed description
This randomized clinical trial will evaluate the combined effect of the Buteyko breathing technique and chest wall mobilization on pulmonary functions and quality of life in chronic smokers. A sample size of 40 is calculated through a non-probability convenient sampling technique. Participants will be recruited into Group 1 and Group 2 by lottery method (without replacement). Group 1 will be engaged in the Buteyko breathing technique + Chest Wall Mobilization and Group 2 will undergo Buteyko Breathing Technique + Without Chest Wall Mobilization. Pre and post-outcome measures of pulmonary functions will be measured through a digital spirometer and quality of life will be assessed by the St George Quality of Life Questionnaire.
Spirometry assesses the amount and speed of air that can be inhaled and exhaled. Key measurements include Forced Vital Capacity (FVC): The maximum volume of air forcefully exhaled after a full inhalation. Forced Expiratory Volume in 1 Second (FEV1): The volume of air exhaled in the first second of the FVC test, indicates how quickly the lungs can be emptied.
St Saint Georg quality of life questionnaire for assessing the QOL. The SGRQ is a standardized self-administered airway disease-specific questionnaire divided into 2 subscales, a total of 12 questions. For each subscale and the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
- Conditions
- Chronic Smokers
- Being tested
- Buteyko breathing technique, Chest Wall Mobilization
- Keywords
- Buteyko Breathing Technique, Chest wall Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko breathing techniqueOther
Participants will be advised to sit in a comfortable and relaxed position and take a shallow breath through nose, partially filling the lungs. Hold breath for 2-3 seconds and exhale slowly through the nose and emptying the lungs.
Chest Wall MobilizationOther
It started with positioning, sitting or standing with good posture, and relaxing shoulders and arms. Hands were placed on the chest with fingers wide and thumbs on side of ribcage. Inhale deep breaths with expansion of chest and hands move outward. Exhale slowly allowed the chest to drop and the hands to move inward.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko breathing technique, Chest wall mobilization | Experimental | Deep breathing exercises for 5 minutes. After the 5-minute resting interval Buteyko breathing technique and chest wall mobilization of 5 minutes Chest wall mobilization with 8-10 repetitions. Total time duration will be 30 minutes. 2 sessions per week Receives: Other: Buteyko breathing technique; Other: Chest Wall Mobilization |
| Buteyko breathing technique | Active comparator | Deep breathing for 5 minutes as a baseline Buteyko technique of 2 sets of 8-10 repetitions for 2 days a week. Chest wall mobilization will not be included in Group 2. Repeat the breathing cycle for 5-10 minutes, 2-3 times a day. Total time duration will be 30 minutes. Receives: Other: Buteyko breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1(Forced Expiratory Volume per second)
Pulmonary Function Test using Digital Spirometer. • Forced Vital Capacity (FVC): the amount of air that can be forcefully exhaled after taking a complete breath.
Measured: Pre and Post after 1 week
FVC(Forced Vital Capacity)
Pulmonary Function Test using Digital Spirometer. the amount of air expelled during the first second of the forced ventilation test (FVC), which measures how rapidly the lungs can empty.
Measured: Pre and Post after 1 week
St George Questionnaire
To assess the Quality of Life. The total questionnaire score is 100 (highest impairment) while the subscale values range from zero (no impairment)
Measured: Pre and Post after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start13 Jun 2024
- Primary completion13 Aug 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SmokersStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasneem Shehzadi, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537479
- Sponsor's protocol ID
- REC/RCR & AHS/23/0373
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Buteyko Breathing Technique and Chest Wall Mobilization on Pulmonary Functions and Quality of Life in Chronic Smokers
- ClinicalTrials.gov ID
- NCT06537479
- Acronym / sponsor ID
- REC/RCR & AHS/23/0373
- Conditions
- Chronic Smokers
- Keywords
- Buteyko Breathing Technique, Chest wall Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 13 Aug 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 5 Aug 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 study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS \& AHS. A non-probability convenient sampling technique will be used to recruit the individuals. Group 1-Buteyko breathing technique + Chest Wall Mobilization and Group 2-Buteyko Breathing Technique + Without Chest Wall Mobilization
Detailed description
This randomized clinical trial will evaluate the combined effect of the Buteyko breathing technique and chest wall mobilization on pulmonary functions and quality of life in chronic smokers. A sample size of 40 is calculated through a non-probability convenient sampling technique. Participants will be recruited into Group 1 and Group 2 by lottery method (without replacement). Group 1 will be engaged in the Buteyko breathing technique + Chest Wall Mobilization and Group 2 will undergo Buteyko Breathing Technique + Without Chest Wall Mobilization. Pre and post-outcome measures of pulmonary functions will be measured through a digital spirometer and quality of life will be assessed by the St George Quality of Life Questionnaire.
Spirometry assesses the amount and speed of air that can be inhaled and exhaled. Key measurements include Forced Vital Capacity (FVC): The maximum volume of air forcefully exhaled after a full inhalation. Forced Expiratory Volume in 1 Second (FEV1): The volume of air exhaled in the first second of the FVC test, indicates how quickly the lungs can be emptied.
St Saint Georg quality of life questionnaire for assessing the QOL. The SGRQ is a standardized self-administered airway disease-specific questionnaire divided into 2 subscales, a total of 12 questions. For each subscale and the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko breathing technique, Chest wall mobilization | Experimental | Other: Buteyko breathing technique, Other: Chest Wall MobilizationDeep breathing exercises for 5 minutes. After the 5-minute resting interval Buteyko breathing technique and chest wall mobilization of 5 minutes Chest wall mobilization with 8-10 repetitions. Total time duration will be 30 minutes. 2 sessions per week |
| Buteyko breathing technique | Active comparator | Other: Buteyko breathing techniqueDeep breathing for 5 minutes as a baseline Buteyko technique of 2 sets of 8-10 repetitions for 2 days a week. Chest wall mobilization will not be included in Group 2. Repeat the breathing cycle for 5-10 minutes, 2-3 times a day. Total time duration will be 30 minutes. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female participants were included
- The age of participants was 40 -55 years.
- Individuals who fulfilled the criteria of smoking which is calculated by multiplying the number of packs smoked per day by the number of years smoked were included.
- Individuals who are current smokers or history of long-term smoking were included.
- Predicted values FEV1 < 75% and FEV1/FVC <70%
Key exclusion criteria (4 listed)
- Participants with neurological disorders were excluded
- Participants with musculoskeletal disorders were excluded as it affects the physical activity of the 6-minute walk test.
- Participants having any pulmonary complications or lung disease were excluded.
- Participants previously involved in any other exercise or physical activity were excluded.
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 |
|---|---|---|
| Buteyko breathing techniqueParticipants will be advised to sit in a comfortable and relaxed position and take a shallow breath through nose, partially filling the lungs. Hold breath for 2-3 seconds and exhale slowly through the nose and emptying the lungs. | Other | Buteyko breathing technique, Buteyko breathing technique, Chest wall mobilization |
| Chest Wall MobilizationIt started with positioning, sitting or standing with good posture, and relaxing shoulders and arms. Hands were placed on the chest with fingers wide and thumbs on side of ribcage. Inhale deep breaths with expansion of chest and hands move outward. Exhale slowly allowed the chest to drop and the hands to move inward. | Other | Buteyko breathing technique, Chest wall mobilization |
Primary outcome
FEV1(Forced Expiratory Volume per second)
Time frame: Pre and Post after 1 week
Pulmonary Function Test using Digital Spirometer. • Forced Vital Capacity (FVC): the amount of air that can be forcefully exhaled after taking a complete breath.
FVC(Forced Vital Capacity)
Time frame: Pre and Post after 1 week
Pulmonary Function Test using Digital Spirometer. the amount of air expelled during the first second of the forced ventilation test (FVC), which measures how rapidly the lungs can empty.
St George Questionnaire
Time frame: Pre and Post after 1 week
To assess the Quality of Life. The total questionnaire score is 100 (highest impairment) while the subscale values range from zero (no impairment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Tasneem Shehzadi, Mphil 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 Buteyko breathing technique and Chest Wall Mobilization in people with Chronic Smokers, 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 4 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: status not confirmed, as of the sponsor's last update on 5 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kinza Saleem, DPT (03067639002, Kinza.saleem81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1(Forced Expiratory Volume per second) (time frame: Pre and Post after 1 week). 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?
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 5 Aug 2024.