SmokingNCT06671288
"Effects of Balloon-blowing Exercises With Abdominal & Lumbar Core Muscle Activation Position Among Smokers"
A study testing Balloon-blowing exercises with abdominal & lumbar core muscle activation position. and Diaphragmatic breathing exercise in people with Smoking, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The principle function of the lungs is the facilitation of the gaseous exchange, commonly referred as respiratory or breathing. Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's… Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Smoking
- What is being tested?
- Balloon-blowing exercises with abdominal & lumbar core muscle activation position. and Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 1 Feb 2025
- 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 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults: aged (25-59 years)
- Gender: Both males and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- COPD classes (mild, moderate ) according to GOLD COPD Guidelines
- Participating voluntarily and follow the instructions \& performing
- The number of packs of cigarettes smoked per day by the number of years the person has smoked.
- pack yr = 20 cig/day x 1 yrs
- pack yr = 20 cig/day x 2 yrs
Who cannot join
- Severe cases of obstruction like Severe asthma \& status asthmaticus, Severe COPD, bullous emphysema for pneumothorax.
- Any congenital deformities of chest wall, Demonstrated neuromuscular or neurological deficit/disease of chest wall
- Other serious Cardiopulmonary diseases including pulmonary embolism, pulmonary ----Hypertension, Active TB, pneumonias or other acute illnesses
- Any recent cardiothoracic or abdominal surgery, trauma or injury
- Pregnancy
- Any psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Sana Bashir, PhD*, 0321-8529475, sana.bashir65@gmail.com
About this study
The principle function of the lungs is the facilitation of the gaseous exchange, commonly referred as respiratory or breathing. Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.
Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.
Read the detailed description
Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health, including a progressive impairment of lung function. Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.
Smokers may experience inflammation and narrowing of their airways, resulting in increased resistance to the outward flow of air during exhalation. This restriction in airflow can negatively impact respiratory parameters, exercise tolerance, and overall quality of life.
Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.
- Conditions
- Smoking
- Being tested
- Balloon-blowing exercises with abdominal & lumbar core muscle activation position., Diaphragmatic breathing exercise
- Keywords
- dysnea, Cigarette smoking, spirometry, Quality of life
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-blowing exercises with abdominal & lumbar core muscle activation position.Other
Patients in this group will recieve Balloon-blowing exercises with abdominal and lumbar core muscles activation position Total 4 weeks protocol will be followed in which 3 sessions per week will be supervised by physical therapist.
FREQUENCY: 3 times a week, INTENSITY : Moderate, TIME: 4 sets of balloon-blowing with 1 min rest (30 mins) TYPE: Balloon-blowing with abdominal \& lumbar core muscle activation position, DURATION : 4 weeks
Diaphragmatic breathing exerciseOther
Participants in this group will only be receiving diaphragmatic breathing exercise for 4 weeks. FREQUENCY: 3 times a week , INTENSITY: Moderate, TIME: 4 sets of diaphragmatic breathing with 1 min rest, TYPE: Diaphragmatic breathing, DURATION: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients in this group will receive balloon -blowing exercise with abdominal \& lumbar core muscle activation position Total 4 weeks protocol. Three sessions per week will be supervised by physical therapist. Receives: Other: Balloon-blowing exercises with abdominal & lumbar core muscle activation position. |
| Control group | Active comparator | Patients will receive diaphragmatic breathing exercises. Total 4 weeks protocol.
Before and after 4 weeks pre and post interventional values will be taken. Receives: Other: Diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC (forced vital capacity):
FVC (forced vital capacity): The amount of air that can be maximum forcefully be exhaled after taking deep breath.
Measured: 4 weeks
FEV1
FEV1(Forced expiratory volume in 1 second): The volume of air that is forcefully exhaled in one second.
Measured: 4 weeks
FEV1/FVC
FEV1/FVC: The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Measured: 4 weeks
PEF (Peak expiratory flow)
PEF( Peak expiratory flow): Measurement of the highest speed at which a individual can exhale air from their lungs after a full inhalation.
Measured: 4 Weeks
Dyspnea
Evaluation will be done using mMRC dyspnea scale (0-4). 0 I only get breathless with strenuous exercise
- I get short of breath when hurrying on level ground or walking up a slight hill
- On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace
- I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing
Measured: 4 Weeks
Quality of life of participant
Quality of life questionnaire (SF-36) will be used to evaluate smokers QOLSF-36 Questionnaire (0-100). Each question carries equal weight the lower the score the more the disability. The higher the score the lesser the disability.
0: Maximum disability 100: No disability
Measured: 4 weeks
Oxygen saturation
Pulse oximeter will be used to measure oxygen saturation
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 posted4 Nov 2024
- Study start15 Aug 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- This is a randomized controlled trial having two groups. One group will receive (interventional group) balloon-blowing exercises with abdominal \& lumbar core muscles activation position. and the other group (control group) will receive Diaphragmatic breathing exercise.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671288
- Sponsor's protocol ID
- FUI/CTR/2024/27
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Balloon-blowing Exercises With Abdominal & Lumbar Core Muscle Activation Position Among Smokers"
- ClinicalTrials.gov ID
- NCT06671288
- Acronym / sponsor ID
- FUI/CTR/2024/27
- Conditions
- Smoking
- Keywords
- dysnea, Cigarette smoking, spirometry, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 4 Nov 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 principle function of the lungs is the facilitation of the gaseous exchange, commonly referred as respiratory or breathing. Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.
Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.
Detailed description
Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health, including a progressive impairment of lung function. Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.
Smokers may experience inflammation and narrowing of their airways, resulting in increased resistance to the outward flow of air during exhalation. This restriction in airflow can negatively impact respiratory parameters, exercise tolerance, and overall quality of life.
Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive (interventional group) balloon-blowing exercises with abdominal \& lumbar core muscles activation position. and the other group (control group) will receive Diaphragmatic breathing exercise.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Balloon-blowing exercises with abdominal & lumbar core muscle activation position.Patients in this group will receive balloon -blowing exercise with abdominal \& lumbar core muscle activation position Total 4 weeks protocol. Three sessions per week will be supervised by physical therapist. |
| Control group | Active comparator | Other: Diaphragmatic breathing exercisePatients will receive diaphragmatic breathing exercises. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults: aged (25-59 years)
- Gender: Both males and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- COPD classes (mild, moderate ) according to GOLD COPD Guidelines
- Participating voluntarily and follow the instructions \& performing
Key exclusion criteria (6 listed)
- Severe cases of obstruction like Severe asthma \& status asthmaticus, Severe COPD, bullous emphysema for pneumothorax.
- Any congenital deformities of chest wall, Demonstrated neuromuscular or neurological deficit/disease of chest wall
- Other serious Cardiopulmonary diseases including pulmonary embolism, pulmonary ----Hypertension, Active TB, pneumonias or other acute illnesses
- Any recent cardiothoracic or abdominal surgery, trauma or injury
- Pregnancy
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 |
|---|---|---|
| Balloon-blowing exercises with abdominal & lumbar core muscle activation position.Patients in this group will recieve Balloon-blowing exercises with abdominal and lumbar core muscles activation position Total 4 weeks protocol will be followed in which 3 sessions per week will be supervised by physical therapist. FREQUENCY: 3 times a week, INTENSITY : Moderate, TIME: 4 sets of balloon-blowing with 1 min rest (30 mins) TYPE: Balloon-blowing with abdominal \& lumbar core muscle activation position, DURATION : 4 weeks | Other | Interventional group |
| Diaphragmatic breathing exerciseParticipants in this group will only be receiving diaphragmatic breathing exercise for 4 weeks. FREQUENCY: 3 times a week , INTENSITY: Moderate, TIME: 4 sets of diaphragmatic breathing with 1 min rest, TYPE: Diaphragmatic breathing, DURATION: 4 weeks | Other | Control group |
Primary outcome
FVC (forced vital capacity):
Time frame: 4 weeks
FVC (forced vital capacity): The amount of air that can be maximum forcefully be exhaled after taking deep breath.
FEV1
Time frame: 4 weeks
FEV1(Forced expiratory volume in 1 second): The volume of air that is forcefully exhaled in one second.
FEV1/FVC
Time frame: 4 weeks
FEV1/FVC: The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
PEF (Peak expiratory flow)
Time frame: 4 Weeks
PEF( Peak expiratory flow): Measurement of the highest speed at which a individual can exhale air from their lungs after a full inhalation.
Dyspnea
Time frame: 4 Weeks
Evaluation will be done using mMRC dyspnea scale (0-4). 0 I only get breathless with strenuous exercise 1. I get short of breath when hurrying on level ground or walking up a slight hill 2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace 3. I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground 4. I am too breathless to leave the house or I am breathless when dressing
Quality of life of participant
Time frame: 4 weeks
Quality of life questionnaire (SF-36) will be used to evaluate smokers QOLSF-36 Questionnaire (0-100). Each question carries equal weight the lower the score the more the disability. The higher the score the lesser the disability. 0: Maximum disability 100: No disability
Oxygen saturation
Time frame: 4 weeks
Pulse oximeter will be used to measure oxygen saturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon-blowing exercises with abdominal & lumbar core muscle activation position. and Diaphragmatic breathing exercise in people with Smoking, run by Foundation University Islamabad 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 8 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: status not confirmed, as of the sponsor's last update on 4 Nov 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 Tooba Shahbaz, MS-CPT* (0340-5416747, tshahbaz59@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (forced vital capacity): (time frame: 4 weeks). The study lists 7 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 4 Nov 2024.