Lung Disease ChronicNCT05771766
Postural Drainage With and Without Aerobic Training on Chronic Suppurative Lung Disease
A study testing Postural Drainge and aerobic training and Postural Drainage in people with Lung Disease Chronic, run by Riphah International University at 1 site in Pakistan.
Trial summary
This will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Lung Disease Chronic
- What is being tested?
- Postural Drainge and aerobic training and Postural Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 5 Dec 2022
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 5-13 years
- Medically stable,
- Patients must have 2 episodes of productive cough, each episode lasting for 4 weeks per year.
Who cannot join
- Non-Chronic Suppurative Lung Disease related chronic disease
- Chronic Suppurative Lung Disease-related conditions posing an increased risk to the patient when exercising.
- children with any MSK-disorder or gait abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Postural Drainage With and Without Aerobic Training on Respiratory Rate, Oxygen Saturation and Endurance in Chronic Suppurative Lung Disease
This will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include a 5-step stair-climbing and a 10-step walk during each session. Data will be collected before and at the end of two weeks. Respiratory Rate, Pulse Oximeter, 10-meter Endurance walk test, and Pediatric Cough Questionnaire will be used to collect data pre and post-treatment. Data will be analyzed by use of SPSS Version 2010. Data will be presented in the form of mean and standard deviation.
Read the detailed description
Chronic suppurative lung disease (csld) is a clinical syndrome in children with respiratory symptoms and signs. Children who have bronchiectasis symptoms but non-diagnostic scans are described as having chronic suppurative lung disease (csld). Postural drainage improves secretion clearance techniques, it is equally as effective as other airway clearance techniques. This study will focus on the implementation of postural drainage and aerobic training in this disease to find their effect on respiratory rate, oxygen saturation, and endurance.
- Conditions
- Lung Disease Chronic
- Being tested
- Postural Drainge and aerobic training, Postural Drainage
- Keywords
- CSLD, Respiratory Rate, Endurance, Oxygen Saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural Drainge and aerobic trainingOther
This will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include 5-step stair-climbing and 10 step walk during each session.
Postural DrainageOther
Postural Drainage
| Study group | Role | What they receive |
|---|---|---|
| Postural Drainage with Aerobic Training | Experimental | The intervention group will undergo Postural Drainage and additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include a 5-step stair-climbing and 10-step walk during each session. Receives: Other: Postural Drainge and aerobic training |
| Postural Drainage | Active comparator | the group will receive postural drainage as baseline treatment thrice a week for two weeks. Receives: Other: Postural Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
The respiratory rate is the rate at which breathing occurs; it is set and controlled by the respiratory center of the brain.
Measured: 2 weeks
Oxygen Saturation
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Measured: 2 Weeks
10 Meter Walk Test
The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed
Measured: 2 Weeks
Secondary outcomes (1)
5-item Pediatric Cough Questionnair
Used to measure frequency of child's cough with aa 6-point Likert-scale. Questionnair have 5 Questions to be answered by parent.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Sep 2022
- Primary completion5 Oct 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Disease ChronicStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771766
- Sponsor's protocol ID
- REC/RCR& AHS/22/0737
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2023
- Last updated
- 1 Aug 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postural Drainage With and Without Aerobic Training on Respiratory Rate, Oxygen Saturation and Endurance in Chronic Suppurative Lung Disease
- ClinicalTrials.gov ID
- NCT05771766
- Acronym / sponsor ID
- REC/RCR& AHS/22/0737
- Conditions
- Lung Disease Chronic
- Keywords
- CSLD, Respiratory Rate, Endurance, Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 16 Mar 2023 (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 will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include a 5-step stair-climbing and a 10-step walk during each session. Data will be collected before and at the end of two weeks. Respiratory Rate, Pulse Oximeter, 10-meter Endurance walk test, and Pediatric Cough Questionnaire will be used to collect data pre and post-treatment. Data will be analyzed by use of SPSS Version 2010. Data will be presented in the form of mean and standard deviation.
Detailed description
Chronic suppurative lung disease (csld) is a clinical syndrome in children with respiratory symptoms and signs. Children who have bronchiectasis symptoms but non-diagnostic scans are described as having chronic suppurative lung disease (csld). Postural drainage improves secretion clearance techniques, it is equally as effective as other airway clearance techniques. This study will focus on the implementation of postural drainage and aerobic training in this disease to find their effect on respiratory rate, oxygen saturation, and endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural Drainage with Aerobic Training | Experimental | Other: Postural Drainge and aerobic trainingThe intervention group will undergo Postural Drainage and additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include a 5-step stair-climbing and 10-step walk during each session. |
| Postural Drainage | Active comparator | Other: Postural Drainagethe group will receive postural drainage as baseline treatment thrice a week for two weeks. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of 5-13 years
- Medically stable,
- Patients must have 2 episodes of productive cough, each episode lasting for 4 weeks per year.
Key exclusion criteria (3 listed)
- Non-Chronic Suppurative Lung Disease related chronic disease
- Chronic Suppurative Lung Disease-related conditions posing an increased risk to the patient when exercising.
- children with any MSK-disorder or gait abnormalities
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 |
|---|---|---|
| Postural Drainge and aerobic trainingThis will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include 5-step stair-climbing and 10 step walk during each session. | Other | Postural Drainage with Aerobic Training |
| Postural DrainagePostural Drainage | Other | Postural Drainage |
Primary outcome
Respiratory Rate
Time frame: 2 weeks
The respiratory rate is the rate at which breathing occurs; it is set and controlled by the respiratory center of the brain.
Oxygen Saturation
Time frame: 2 Weeks
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
10 Meter Walk Test
Time frame: 2 Weeks
The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed
1 secondary outcome
5-item Pediatric Cough Questionnair
Time frame: 2 Weeks
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 1 Aug 2023.
- 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.
Arnab Altaf, Mphill 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 Postural Drainge and aerobic training and Postural Drainage in people with Lung Disease Chronic, 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 3 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: finished, as of the sponsor's last update on 1 Aug 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?
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?
Respiratory Rate (time frame: 2 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?
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 1 Aug 2023.