AsthmaNCT05618873
Comparison of Flutter and PEP Mask on Chest Clearance, Dyspnea in Elderly Asthmatic Patients
A study testing Flutter device and positive expiratory pressure mask in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Flutter device and positive expiratory pressure mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2022to Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical Diagnosis Of Asthma
- Both age above 40-60 years of age
- Both gender
- No previous surgery
Who cannot join
- Other pulmonary disease
- Neurological problems
- Rib fracture
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Allied hospital
Faisalābad, Punjab Province, 38000
madiha younas, MS, 0333-8148025, madiha.younas@riphah.edu.pk
Ali hassan, MSCPPT
About this study
Official title: Comparative Effects of Flutter and Positive Expiratory Pressure on Chest Clearance and Dyspnea in Elderly Asthmatic Patients
This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.
Read the detailed description
This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. Treatment will be given to all the participants 3 sessionsin a week, or 2 weeks and post treatment evaluation will be done after every week. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.
- Conditions
- Asthma
- Being tested
- Flutter device, positive expiratory pressure mask
- Keywords
- Flutter, PEP Mask, Chest Clearance, Dyspnea
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutter deviceDevice
The flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees.
positive expiratory pressure maskDevice
The PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask.
Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times.
| Study group | Role | What they receive |
|---|---|---|
| flutter device therapy | Experimental | The flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees. Receives: Device: Flutter device |
| Positive Expiratory Pressure Mask | Experimental | The PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask.
Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. Receives: Device: positive expiratory pressure mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST. GEORGE'S RESPIRATORY QUESTINAIR
The SGRQ is designed to measure health impairment in patients with asthma and COPD. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. 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: 2weeks
PULMONARY FUNCTION TEST
Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. The most basic test is spirometry. Spirometry is used to screen for diseases that affect lung volumes. It also is used to screen for diseases that affect the airways, such as COPD or asthma.
Measured: 2weeeks
SPUTUM DIARY
The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms)
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 May 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha younas, MS, Principal investigator, riphah internationl university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618873
- Sponsor's protocol ID
- REC/ ALI HASSAN
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 26 Jan 2023
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Flutter and Positive Expiratory Pressure on Chest Clearance and Dyspnea in Elderly Asthmatic Patients
- ClinicalTrials.gov ID
- NCT05618873
- Acronym / sponsor ID
- REC/ ALI HASSAN
- Conditions
- Asthma
- Keywords
- Flutter, PEP Mask, Chest Clearance, Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 16 Nov 2022 (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 a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.
Detailed description
This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. Treatment will be given to all the participants 3 sessionsin a week, or 2 weeks and post treatment evaluation will be done after every week. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flutter device therapy | Experimental | Device: Flutter deviceThe flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees. |
| Positive Expiratory Pressure Mask | Experimental | Device: positive expiratory pressure maskThe PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask. Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical Diagnosis Of Asthma
- Both age above 40-60 years of age
- Both gender
- No previous surgery
Key exclusion criteria (3 listed)
- Other pulmonary disease
- Neurological problems
- Rib fracture
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 |
|---|---|---|
| Flutter deviceThe flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees. | Device | flutter device therapy |
| positive expiratory pressure maskThe PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask. Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. | Device | Positive Expiratory Pressure Mask |
Primary outcome
ST. GEORGE'S RESPIRATORY QUESTINAIR
Time frame: 2weeks
The SGRQ is designed to measure health impairment in patients with asthma and COPD. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. 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.
PULMONARY FUNCTION TEST
Time frame: 2weeeks
Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. The most basic test is spirometry. Spirometry is used to screen for diseases that affect lung volumes. It also is used to screen for diseases that affect the airways, such as COPD or asthma.
SPUTUM DIARY
Time frame: 2weeks
The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Madiha younas, MS principal investigator
riphah internationl 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 Flutter device and positive expiratory pressure mask in people with Asthma, 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 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 26 Jan 2023. 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 Imran amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ST. GEORGE'S RESPIRATORY QUESTINAIR (time frame: 2weeks). 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 26 Jan 2023.