PneumoniaNCT06319690
Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients
A study testing Lion's Breath Technique and Chest Percussion Therapy in people with Pneumonia, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Lion's Breath Technique and Chest Percussion Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the post-acute phase of pneumonia recovery.
- Adults aged 18 years and above diagnosed with pneumonia.
- Both male and female will be included.
- Participants should be in stable health conditions to participate in the Study.
- Willing to comply with the study protocol
Who cannot join
- Patients with severe or life-threatening pneumonia requiring immediate intensive care
- Patients with physical or cognitive limitations
- Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
- Pregnant or breastfeeding women
- Individuals with musculoskeletal or neurological conditions
- Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area
Trial locations and contacts
1 site in 1 country.
About this study
This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Read the detailed description
The main objective of the study is to determine the effect of lion's breath technique along with chest percussion therapy in pneumonia patients. This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Participants included will be adults aged 18 years and above diagnosed with pneumonia. Willing to comply with the study protocol. Both male and female will be included. Participants should be in stable health conditions to participate in the Study. Patients with severe or life-threatening pneumonia requiring immediate intensive care and patients with physical or cognitive limitations. Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma. Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions and Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area will be excluded. Group A (Lion's Breath Technique + Chest Percussion Therapy) Daily supervised Lion's Breath Technique sessions will be for 20 minutes for 1 week. Trained physiotherapists administer chest percussion therapy will be to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week. Pre and post data will be gathered. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
- Conditions
- Pneumonia
- Being tested
- Lion's Breath Technique, Chest Percussion Therapy
- Keywords
- Breathing exercises, Lion's Breath Technique, Pulmonary rehabilitation
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lion's Breath TechniqueOther
Patients receive training in Lion's Breath Technique, emphasizing deep diaphragmatic breathing and controlled exhalation.
Daily supervised Lion's Breath Technique sessions for 20 minutes for 1 week
Chest Percussion TherapyOther
Trained physiotherapists administer chest percussion therapy to mobilize secretions and improve lung function.
Daily session for 30 minutes for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Lion breath) | Experimental | Lion's Breath Technique + Chest Percussion Therapy Receives: Other: Lion's Breath Technique; Other: Chest Percussion Therapy |
| Control Group (Routine treatment) | Active comparator | Chest Percussion Therapy only Receives: Other: Chest Percussion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
George respiratory questionnaire
The George respiratory questionnaire is Disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total 50 items, 2 parts (3 components). Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 1 Week
Forced vital capacity (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry
Measured: 1 Week
Borg Dyspnea Scale
The borg dyspnea scale is a numerical scale that measures the intensity of breathlessness of fatigue. It will be used to assess the baseline and posttest symptoms of patients with respiratory and cardiac condition.
This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal
Measured: 1 Week
Forced expiratory volume (FEV1)
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. it is measured using Spirometer.
Measured: 1 Week
FEV1/FVC Ratio
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, measured using Spirometer.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 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 PneumoniaStudies 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 Control Trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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
- NCT06319690
- Sponsor's protocol ID
- REC/RCR&AHS/23/0362
- 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 Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients
- ClinicalTrials.gov ID
- NCT06319690
- Acronym / sponsor ID
- REC/RCR&AHS/23/0362
- Conditions
- Pneumonia
- Keywords
- Breathing exercises, Lion's Breath Technique, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 20 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.
This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Detailed description
The main objective of the study is to determine the effect of lion's breath technique along with chest percussion therapy in pneumonia patients. This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Participants included will be adults aged 18 years and above diagnosed with pneumonia. Willing to comply with the study protocol. Both male and female will be included. Participants should be in stable health conditions to participate in the Study. Patients with severe or life-threatening pneumonia requiring immediate intensive care and patients with physical or cognitive limitations. Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma. Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions and Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area will be excluded. Group A (Lion's Breath Technique + Chest Percussion Therapy) Daily supervised Lion's Breath Technique sessions will be for 20 minutes for 1 week. Trained physiotherapists administer chest percussion therapy will be to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week. Pre and post data will be gathered. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Lion breath) | Experimental | Other: Lion's Breath Technique, Other: Chest Percussion TherapyLion's Breath Technique + Chest Percussion Therapy |
| Control Group (Routine treatment) | Active comparator | Other: Chest Percussion TherapyChest Percussion Therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in the post-acute phase of pneumonia recovery.
- Adults aged 18 years and above diagnosed with pneumonia.
- Both male and female will be included.
- Participants should be in stable health conditions to participate in the Study.
- Willing to comply with the study protocol
Key exclusion criteria (6 listed)
- Patients with severe or life-threatening pneumonia requiring immediate intensive care
- Patients with physical or cognitive limitations
- Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
- Pregnant or breastfeeding women
- Individuals with musculoskeletal or neurological conditions
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 |
|---|---|---|
| Lion's Breath TechniquePatients receive training in Lion's Breath Technique, emphasizing deep diaphragmatic breathing and controlled exhalation. Daily supervised Lion's Breath Technique sessions for 20 minutes for 1 week | Other | Experimental Group (Lion breath) |
| Chest Percussion TherapyTrained physiotherapists administer chest percussion therapy to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week. | Other | Control Group (Routine treatment), Experimental Group (Lion breath) |
Primary outcome
George respiratory questionnaire
Time frame: 1 Week
The George respiratory questionnaire is Disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total 50 items, 2 parts (3 components). Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations.
Forced vital capacity (FVC)
Time frame: 1 Week
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry
Borg Dyspnea Scale
Time frame: 1 Week
The borg dyspnea scale is a numerical scale that measures the intensity of breathlessness of fatigue. It will be used to assess the baseline and posttest symptoms of patients with respiratory and cardiac condition. This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal
Forced expiratory volume (FEV1)
Time frame: 1 Week
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. it is measured using Spirometer.
FEV1/FVC Ratio
Time frame: 1 Week
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, measured using Spirometer.
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 Lion's Breath Technique and Chest Percussion Therapy in people with Pneumonia, 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?
George respiratory questionnaire (time frame: 1 Week). 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 23 Jul 2024.