PneumoniaNCT06461884
Combined Effects Of Percussion With Diaphragmatic Breathing Exercises On Airway Clearance In Elderly Pneumonia Patients
A study testing Percussions and , Diaphragmatic breathing exercise in people with Pneumonia, run by Riphah International University at 1 site in Pakistan.
Trial summary
The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Percussions and , Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 15 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 40-60,
- Both males and females
- Those patients who will be vitally stable (oxygen saturation, respiratory rate)
- Pneumonia diagnosed patients (Community Acquired Pneumonia)
Who cannot join
- Patients with heart disease
- Patients with neurological disorders such as: Alzheimer, epilepsy, Parkinson disease
- Patients with orthopedic conditions
- Other pulmonary complications (atelectasis, diaphragmatic injury, ARDS)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Sidra Faisal, MS.CPPT, 03022001847, sidra.faisal@riphah.edu.pk
About this study
Official title: Combined Effects of Percussion With Diaphragmatic Breathing Exercises on Airway Clearance in Elderly Pneumonia Patients
The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients.
Read the detailed description
It will be a randomized clinical trial. And the data will be conducted from Mayo Hospital Lahore. Convenient sampling technique will be applied on patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A and group B to collect data. For this purpose, I will divide my sample size into two groups. The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients. Before and after each session, the primary and secondary outcomes will be measured for both groups. After collecting the data, the data will be analyzed by using SPSS version 25.
- Conditions
- Pneumonia
- Being tested
- Percussions, , Diaphragmatic breathing exercise
- Keywords
- CAP, Diaphragmatic breathing, Percussion and Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PercussionsOther
Group A: Percussions and diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks
, Diaphragmatic breathing exerciseOther
Group B: Diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Percussions | Experimental | Group A: Percussions and diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks Receives: Other: Percussions |
| Diaphragmatic breathing exercise | Experimental | Group B: Diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks Receives: Other: , Diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCSS
BCSS: BCSS is a patient-reported three-item questionnaire for cough, breathlessness and sputum rating on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms).
Measured: 4 weeks
HRQOL for quality of life
One of the many factors frequently investigated in the realm of medical research and treatment is HRQOL. It covers a broad spectrum of man experience, contains how we operate and how we perceive illness. The World Health Organization defines health as a condition of whole physical, intellectual, and interpersonal well-being and not just the absence of disease, which is the foundation for modern interpretations of HRQOL.
Measured: 4 weeks
Rated Perceived Exertion (RPE) Scale
Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes. The RPE scale can help you manage exercise intensity and improve cardio training and endurance
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 posted17 Jun 2024
- Study start10 Mar 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks
- 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
- Sidra Faisal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461884
- Sponsor's protocol ID
- REC/RCR & AHS/23/0379
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. doi: 10.1086/425615. Epub 2004 Nov 8.
PubMed 15578365Brar NK, Niederman MS. Management of community-acquired pneumonia: a review and update. Ther Adv Respir Dis. 2011 Feb;5(1):61-78. doi: 10.1177/1753465810381518. Epub 2010 Oct 8.
PubMed 20935033Marchello CS, Ebell MH, Dale AP, Harvill ET, Shen Y, Whalen CC. Signs and Symptoms That Rule out Community-Acquired Pneumonia in Outpatient Adults: A Systematic Review and Meta-Analysis. J Am Board Fam Med. 2019 Mar-Apr;32(2):234-247. doi: 10.3122/jabfm.2019.02.180219.
PubMed 30850460Miyashita N, Yamauchi Y. Bacterial Pneumonia in Elderly Japanese Populations. Jpn Clin Med. 2018 Jan 3;9:1179670717751433. doi: 10.1177/1179670717751433. eCollection 2018.
PubMed 29434484
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Percussion With Diaphragmatic Breathing Exercises on Airway Clearance in Elderly Pneumonia Patients
- ClinicalTrials.gov ID
- NCT06461884
- Acronym / sponsor ID
- REC/RCR & AHS/23/0379
- Conditions
- Pneumonia
- Keywords
- CAP, Diaphragmatic breathing, Percussion and Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 17 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 group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients.
Detailed description
It will be a randomized clinical trial. And the data will be conducted from Mayo Hospital Lahore. Convenient sampling technique will be applied on patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A and group B to collect data. For this purpose, I will divide my sample size into two groups. The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients. Before and after each session, the primary and secondary outcomes will be measured for both groups. After collecting the data, the data will be analyzed by using SPSS version 25.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks
| Arm | Type | Receives |
|---|---|---|
| Percussions | Experimental | Other: PercussionsGroup A: Percussions and diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks |
| Diaphragmatic breathing exercise | Experimental | Other: , Diaphragmatic breathing exerciseGroup B: Diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 40-60,
Key exclusion criteria (4 listed)
- Patients with heart disease
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 |
|---|---|---|
| PercussionsGroup A: Percussions and diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks | Other | Percussions |
| , Diaphragmatic breathing exerciseGroup B: Diaphragmatic breathing exercise will be performed with 1 session a day for total 3 days in a week for 4 weeks | Other | Diaphragmatic breathing exercise |
Primary outcome
BCSS
Time frame: 4 weeks
BCSS: BCSS is a patient-reported three-item questionnaire for cough, breathlessness and sputum rating on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms).
HRQOL for quality of life
Time frame: 4 weeks
One of the many factors frequently investigated in the realm of medical research and treatment is HRQOL. It covers a broad spectrum of man experience, contains how we operate and how we perceive illness. The World Health Organization defines health as a condition of whole physical, intellectual, and interpersonal well-being and not just the absence of disease, which is the foundation for modern interpretations of HRQOL.
Rated Perceived Exertion (RPE) Scale
Time frame: 4 weeks
Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes. The RPE scale can help you manage exercise intensity and improve cardio training and endurance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 15578365Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. doi: 10.1086/425615. Epub 2004 Nov 8.
- Background: PubMed 20935033Brar NK, Niederman MS. Management of community-acquired pneumonia: a review and update. Ther Adv Respir Dis. 2011 Feb;5(1):61-78. doi: 10.1177/1753465810381518. Epub 2010 Oct 8.
- Background: PubMed 30850460Marchello CS, Ebell MH, Dale AP, Harvill ET, Shen Y, Whalen CC. Signs and Symptoms That Rule out Community-Acquired Pneumonia in Outpatient Adults: A Systematic Review and Meta-Analysis. J Am Board Fam Med. 2019 Mar-Apr;32(2):234-247. doi: 10.3122/jabfm.2019.02.180219.
- Background: PubMed 29434484Miyashita N, Yamauchi Y. Bacterial Pneumonia in Elderly Japanese Populations. Jpn Clin Med. 2018 Jan 3;9:1179670717751433. doi: 10.1177/1179670717751433. eCollection 2018.
- 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.
Sidra Faisal, PP-DPT 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 Percussions and , Diaphragmatic breathing exercise 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 4 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 17 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 Iqbal Tariq, PHD (O3338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCSS (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT06461884, which also lists 4 linked publications.
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 17 Jun 2024.