Tobacco SmokingNCT06444971
Effects of Post-isometric Relaxation Technique on Chest Expansion and Pulmonary Function Tests in Smokers
A study testing Post isometric Relaxation in people with Tobacco Smoking, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The primary objective of the study was to investigate the immediate effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.This quasi-experimental pre-test post-test study will be conducted. Participants of interest would be approached and explained about the research. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Post isometric Relaxation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Mar 2023to 27 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between the ages of 18-60
- Only tobacco cigarette smokers
- Cigarette smokers (with min 2 pack years )
- Both males and females
Who cannot join
- Patients undergoing any surgery
- Symptomatic patients of cystic fibrosis, asthma, exercise induced asthma, unstable angina, bronchitis , bronchiectasis, chest deformities, congenital cardiopulmonary disorders , disc herniation, current rib or vertebral fracture
- Patients with a positive history of trauma, fracture or surgery of the cervical and thoracic spine in the last 12 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Zara Khalid, DPT, MS-CPPT,PHD*, 03335415822, zara.khalid@fui.edu.pk
About this study
The primary objective of the study was to investigate the immediate effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.This quasi-experimental pre-test post-test study will be conducted. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will receive PIR technique on assessory respiratory muscles and chest expansion and pulmonary function tests will be obtained before and after the treatment. Data collection tools for this study are spirometer and measuring tape.
Read the detailed description
Tobacco use, particularly cigarette smoking, is a major cause of disease and death globally. In Pakistan, the prevalence of tobacco use has increased significantly, with men being more likely to smoke than women. Chronic smoking is strongly associated with cardiovascular and respiratory diseases, as well as various forms of cancer. Smoking negatively affects lung function, leading to reduced pulmonary capacity and chronic obstructive pulmonary disease. Additionally, long-term smoking may lead to the loss of respiratory capacity and systemic muscle mass, affecting the performance and work of breathing.
The primary objective of the study was to investigate the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.
This quasi-experimental pre-test post-test study will be conducted over one year at FFH, FUSH and among the general public. A sample will be calculated through pilot study. Participants between the ages of 18-60 will be recruited using convenience sampling. Inclusion criteria included individuals with min of 2 pack-years of tobacco smoking, while exclusion criteria included patients with certain cardiopulmonary medical conditions and those who underwent surgery or physiotherapy within past few months. Data collection tools for this study are spirometer and measuring tape.
There is little to no literature on the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers. The immediate effects of PIR technique demonstrated in this study will provide physical therapists with valuable insight into its use as a treatment option for smokers to improve their pulmonary function. Moreover, this study adds to the existing literature on manual therapy and its effects on smokers. The findings of this study will provide a basis for future research in the field of musculoskeletal rehabilitation and will encourage future researchers to explore this area further.
- Conditions
- Tobacco Smoking
- Being tested
- Post isometric Relaxation
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post isometric RelaxationProcedure or surgery
Post isometric relaxation technique: It is defined as a manual procedure which involves the precisely controlled and specifically directed active contraction of a muscle at varying levels of intensity against a counterforce applied by the therapist.
PIR will be applied to following muscles
- scalene (anterior, middle and posterior)
- sternocleidomastoid
| Study group | Role | What they receive |
|---|---|---|
| PIR Group | Experimental | Post isometric relaxation technique will be applied to sternocleidomastoid and scalene muscles in all the participants with following parameters
* Participant will perform isometric contractions using 20 -30% of their strength
* HOLD TIME: 5-7 sec followed by 20 to 30 sec stretch
* REST TIME: 5 sec
* REPETITIONS: 3-5 repetitions Receives: Procedure: Post isometric Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest expansion
Measuring tape will be used to measure chest expansion at axillary level.
Measured: Immediate after treatment
Forced Vital Capacity(FVC)
the maximum amount of air you can forcibly exhale from your lungs after fully inhaling measured using hand held spirometer
Measured: Immediate after treatment
Forced Expiratory Volume in 1 second (FEV1)
The volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration measured using hand held spirometer.
Measured: Immediate after treatment
Peak Expiratory Flow (PEF)
the volume of air forcefully expelled from the lungs in one quick exhalation measured using hand held spirometer
Measured: Immediate after treatment
FEV1/ FVC
The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung measured using hand held spirometer
Measured: Immediate after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start7 Mar 2023
- Primary completion25 Jun 2024 (estimated)
- Study completion27 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a quasi pre test post test study with a single group. Participants will be recruited according to inclusion criteria .Each participant will receive same treatment .
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06444971
- Sponsor's protocol ID
- FUI/CTR/2024/8
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 6 Jun 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post-isometric Relaxation Technique on Chest Expansion and Pulmonary Function Tests in Smokers
- ClinicalTrials.gov ID
- NCT06444971
- Acronym / sponsor ID
- FUI/CTR/2024/8
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 27 Jun 2024 (estimated)
- First posted
- 6 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.
The primary objective of the study was to investigate the immediate effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.This quasi-experimental pre-test post-test study will be conducted. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will receive PIR technique on assessory respiratory muscles and chest expansion and pulmonary function tests will be obtained before and after the treatment. Data collection tools for this study are spirometer and measuring tape.
Detailed description
Tobacco use, particularly cigarette smoking, is a major cause of disease and death globally. In Pakistan, the prevalence of tobacco use has increased significantly, with men being more likely to smoke than women. Chronic smoking is strongly associated with cardiovascular and respiratory diseases, as well as various forms of cancer. Smoking negatively affects lung function, leading to reduced pulmonary capacity and chronic obstructive pulmonary disease. Additionally, long-term smoking may lead to the loss of respiratory capacity and systemic muscle mass, affecting the performance and work of breathing.
The primary objective of the study was to investigate the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.
This quasi-experimental pre-test post-test study will be conducted over one year at FFH, FUSH and among the general public. A sample will be calculated through pilot study. Participants between the ages of 18-60 will be recruited using convenience sampling. Inclusion criteria included individuals with min of 2 pack-years of tobacco smoking, while exclusion criteria included patients with certain cardiopulmonary medical conditions and those who underwent surgery or physiotherapy within past few months. Data collection tools for this study are spirometer and measuring tape.
There is little to no literature on the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers. The immediate effects of PIR technique demonstrated in this study will provide physical therapists with valuable insight into its use as a treatment option for smokers to improve their pulmonary function. Moreover, this study adds to the existing literature on manual therapy and its effects on smokers. The findings of this study will provide a basis for future research in the field of musculoskeletal rehabilitation and will encourage future researchers to explore this area further.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a quasi pre test post test study with a single group. Participants will be recruited according to inclusion criteria .Each participant will receive same treatment .
| Arm | Type | Receives |
|---|---|---|
| PIR Group | Experimental | Procedure: Post isometric RelaxationPost isometric relaxation technique will be applied to sternocleidomastoid and scalene muscles in all the participants with following parameters * Participant will perform isometric contractions using 20 -30% of their strength * HOLD TIME: 5-7 sec followed by 20 to 30 sec stretch * REST TIME: 5 sec * REPETITIONS: 3-5 repetitions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals between the ages of 18-60
- Only tobacco cigarette smokers
- Cigarette smokers (with min 2 pack years )
- Both males and females
Key exclusion criteria (3 listed)
- Patients undergoing any surgery
- Symptomatic patients of cystic fibrosis, asthma, exercise induced asthma, unstable angina, bronchitis , bronchiectasis, chest deformities, congenital cardiopulmonary disorders , disc herniation, current rib or vertebral fracture
- Patients with a positive history of trauma, fracture or surgery of the cervical and thoracic spine in the last 12 months
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 |
|---|---|---|
| Post isometric RelaxationPost isometric relaxation technique: It is defined as a manual procedure which involves the precisely controlled and specifically directed active contraction of a muscle at varying levels of intensity against a counterforce applied by the therapist. PIR will be applied to following muscles 1. scalene (anterior, middle and posterior) 2. sternocleidomastoid | Procedure or surgery | PIR Group |
Primary outcome
Chest expansion
Time frame: Immediate after treatment
Measuring tape will be used to measure chest expansion at axillary level.
Forced Vital Capacity(FVC)
Time frame: Immediate after treatment
the maximum amount of air you can forcibly exhale from your lungs after fully inhaling measured using hand held spirometer
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Immediate after treatment
The volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration measured using hand held spirometer.
Peak Expiratory Flow (PEF)
Time frame: Immediate after treatment
the volume of air forcefully expelled from the lungs in one quick exhalation measured using hand held spirometer
FEV1/ FVC
Time frame: Immediate after treatment
The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung measured using hand held spirometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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 Post isometric Relaxation in people with Tobacco 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 4 inclusion and 3 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 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huma Masood, MS-MSKPT* (03485289948, humakhalid603@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest expansion (time frame: Immediate after treatment). The study lists 5 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 6 Jun 2024.