AnaemiaNCT06750354
Study on Effect of Papworth Technique in Anemic Asthmatic Pediatrics
A study testing papworth technique and aerobic training in people with Anaemia and Asthma Exacerbations, run by Cairo University.
Trial summary
As asthma is chronic condition which interferes with quality of life and exercise tolerance, so it is important to find out cost-effective alternative for the management of asthma due to increased prevalence and rising health care cost as well . Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anaemia, Asthma Exacerbations
- What is being tested?
- papworth technique and aerobic training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients will be included:
- 40 patients from both genders.
- Participants between the age 12 and 18 years
- Oriented, medically stable and taking their medical treatment
- Mild and moderate asthma
- All patients are diagnosed as iron deficiency anemia
- Body mass index between 18.5 -24.9
Who cannot join
- 1. Have any serious chest diseases, Patients with heart diseases. 2. Patients with neurological disease affecting respiratory muscles or any muscular dystrophy 3. Patients with kidney diseases 4. Patients with liver diseases 5. Other types of anaemia Chest deformities
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Study to Evaluate the Effect of Papworth Technique and Aerobic Training on Hemoglobin and Exercise Tolerance in Anemic Asthmatic Pediatrics
As asthma is chronic condition which interferes with quality of life and exercise tolerance, so it is important to find out cost-effective alternative for the management of asthma due to increased prevalence and rising health care cost as well . Therefore, to provide comprehensive asthma treatment, it is necessary to rule out and address the factor affecting quality of life and exercise tolerance. Asthmatics require stepwise approach which contains assessment treatment planning and review of response. Along with this modification of risk factors, controller therapy is adjusted accordingly. But this is inadequate for asthma management as pharmacological management has some side effects. So, in addition to medical care, Papworth method provides good adjuvant to control asthma symptoms. Asthma subjects require comprehensive approach to deal with these hyperinflation and hyperventilation which are common manifestations of asthma
Read the detailed description
PURPOSE: This study will be conducted to detect the effect of papworth technique and aerobic training on haemoglobin and exercise tolerance in anaemic asthmatic pediatrics
BACKGROUND: One of the chronic inflammatory diseases is asthma, which manifests symptoms like breathlessness, coughing, wheezing, and chest tightness also, commonly at night or in the early morning. Papworth method is easy and safe intervention for asthma control as it is also an adjuvant to medical care. Papworth method reduces these asthma symptoms, improves dysfunctional breathing arising from hypocapnia, and will help in improving quality of life and exercise tolerance.
HYPOTHESESThere is no significant effect of papworth technique and aerobic training on haemoglobin in anaemic asthmatic pediatrics there is no significant effect of papworth technique and aerobic training on exercise tolerance in anaemic asthmatic pediatricsas regards to:
- Haemoglobin level
- Asthma-related Quality of life questionnaire (AQLQ)
- Six-minute walk test.
- Oxygen saturation
- Respiratory rate RESEARCH QUESTION: Is there is an effect of papworth technique and aerobic training on haemoglobin and exercise tolerance in anaemic asthmatic pediatrics?
Patients will be assessed before, after the treatment program. The assessment procedures include the following items:
- Haemoglobin level
- asthma-related Quality of life questionnaire (AQLQ)
- Six-minute walk test.
- Oxygen saturation
- Respiratory rate
Treatment procedure:
Group (A): will receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks.
Group (B): will receive aerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks.
- Conditions
- Anaemia, Asthma Exacerbations
- Being tested
- papworth technique, aerobic training
- Keywords
- papworth technique, aerobic training, anaemic asthmatic pediatrics
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papworth techniqueProcedure or surgery
For Group A: The Papworth breathing technique consists of a series of diaphragmatic breathing and relaxation exercises, and teaches patients which muscles to use when breathing and how to avoid breathing too or too fast by emphasizing nose breathing. The technique is altered to suit activity; this allows the technique to be integrated by patients into their everyday lives with subsequent improvements in quality of life.
aerobic trainingProcedure or surgery
Aerobic training exercises are any activities that raise heart rate and make breathing somewhat harder. The activity you are doing must be constant and continuous. Examples of aerobic activities are
Walking or hiking Jogging or running Biking Swimming Rowing In-line skating Cross-country skiing Exercising on a stair-climber or elliptical machine
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | will receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks. Receives: Procedure: papworth technique; Procedure: aerobic training |
| Control group | Active comparator | aerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks Receives: Procedure: aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level
Oxygen saturation measures how much hemoglobin is bound to oxygen compared to how much hemoglobin remains unbound.
a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%
Measured: AFTER 12 WEEKS
Asthma-related Quality of life questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire used to assess the physical, occupational, emotional, and social qualities of adults aged 17 to 70 years with asthma.
The AQLQ has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ was developed for patients exhibiting mild to moderate asthma. The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment.
Measured: AFTER 12 WEEKS
Six-minute walk test.
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.
Measured: AFTER 12 WEEKS
Oxygen saturation
by using a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%. If you have a lung disease such as COPD or pneumonia, your normal oxygen saturation level may be lower.
Measured: AFTER 12 WEEKS
Respiratory rate
The normal respiratory rate for healthy adults is between 12-20 breaths per minute. At this breathing rate, the carbon dioxide exits the lungs at the same rate that the body produces it. Breathing rates of below 12 or above 20 can mean a disruption in the breathing processes.
Measured: AFTER 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Patients will be included: 1. 40 patients from both genders. 2. Participants between the age 12 and 18 years 3. Oriented, medically stable and taking their medical treatment 4. Mild and moderate asthma 5. All patients are diagnosed as iron deficiency anemia 6. Body mass index between 18.5 -24.9 While excluded if: 1. Have any serious chest diseases, Patients with heart diseases. 2. Patients with neurological disease affecting respiratory muscles or any muscular dystrophy 3. Patients with kidney diseases 4. Patients with liver diseases 5. Other types of anaemia Chest deformities
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Alsayed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750354
- Sponsor's protocol ID
- P.T.REC/012/005437
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 27 Dec 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Effect of Papworth Technique and Aerobic Training on Hemoglobin and Exercise Tolerance in Anemic Asthmatic Pediatrics
- ClinicalTrials.gov ID
- NCT06750354
- Acronym / sponsor ID
- P.T.REC/012/005437
- Conditions
- Anaemia, Asthma Exacerbations
- Keywords
- papworth technique, aerobic training, anaemic asthmatic pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 27 Dec 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.
As asthma is chronic condition which interferes with quality of life and exercise tolerance, so it is important to find out cost-effective alternative for the management of asthma due to increased prevalence and rising health care cost as well . Therefore, to provide comprehensive asthma treatment, it is necessary to rule out and address the factor affecting quality of life and exercise tolerance. Asthmatics require stepwise approach which contains assessment treatment planning and review of response. Along with this modification of risk factors, controller therapy is adjusted accordingly. But this is inadequate for asthma management as pharmacological management has some side effects. So, in addition to medical care, Papworth method provides good adjuvant to control asthma symptoms. Asthma subjects require comprehensive approach to deal with these hyperinflation and hyperventilation which are common manifestations of asthma
Detailed description
PURPOSE: This study will be conducted to detect the effect of papworth technique and aerobic training on haemoglobin and exercise tolerance in anaemic asthmatic pediatrics
BACKGROUND: One of the chronic inflammatory diseases is asthma, which manifests symptoms like breathlessness, coughing, wheezing, and chest tightness also, commonly at night or in the early morning. Papworth method is easy and safe intervention for asthma control as it is also an adjuvant to medical care. Papworth method reduces these asthma symptoms, improves dysfunctional breathing arising from hypocapnia, and will help in improving quality of life and exercise tolerance.
HYPOTHESESThere is no significant effect of papworth technique and aerobic training on haemoglobin in anaemic asthmatic pediatrics there is no significant effect of papworth technique and aerobic training on exercise tolerance in anaemic asthmatic pediatricsas regards to:
- Haemoglobin level
- Asthma-related Quality of life questionnaire (AQLQ)
- Six-minute walk test.
- Oxygen saturation
- Respiratory rate RESEARCH QUESTION: Is there is an effect of papworth technique and aerobic training on haemoglobin and exercise tolerance in anaemic asthmatic pediatrics?
Patients will be assessed before, after the treatment program. The assessment procedures include the following items:
- Haemoglobin level
- asthma-related Quality of life questionnaire (AQLQ)
- Six-minute walk test.
- Oxygen saturation
- Respiratory rate
Treatment procedure:
Group (A): will receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks.
Group (B): will receive aerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be included: 1. 40 patients from both genders. 2. Participants between the age 12 and 18 years 3. Oriented, medically stable and taking their medical treatment 4. Mild and moderate asthma 5. All patients are diagnosed as iron deficiency anemia 6. Body mass index between 18.5 -24.9 While excluded if: 1. Have any serious chest diseases, Patients with heart diseases. 2. Patients with neurological disease affecting respiratory muscles or any muscular dystrophy 3. Patients with kidney diseases 4. Patients with liver diseases 5. Other types of anaemia Chest deformities
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: papworth technique, Procedure: aerobic trainingwill receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks. |
| Control group | Active comparator | Procedure: aerobic trainingaerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 40 patients from both genders.
- Participants between the age 12 and 18 years
- Oriented, medically stable and taking their medical treatment
- Mild and moderate asthma
- All patients are diagnosed as iron deficiency anemia
Key exclusion criteria (2 listed)
- 1. Have any serious chest diseases, Patients with heart diseases. 2. Patients with neurological disease affecting respiratory muscles or any muscular dystrophy 3. Patients with kidney diseases 4. Patients with liver diseases 5. Other types of anaemia Chest deformities
- -
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 |
|---|---|---|
| papworth techniqueFor Group A: The Papworth breathing technique consists of a series of diaphragmatic breathing and relaxation exercises, and teaches patients which muscles to use when breathing and how to avoid breathing too or too fast by emphasizing nose breathing. The technique is altered to suit activity; this allows the technique to be integrated by patients into their everyday lives with subsequent improvements in quality of life. | Procedure or surgery | Study group |
| aerobic trainingAerobic training exercises are any activities that raise heart rate and make breathing somewhat harder. The activity you are doing must be constant and continuous. Examples of aerobic activities are Walking or hiking Jogging or running Biking Swimming Rowing In-line skating Cross-country skiing Exercising on a stair-climber or elliptical machine | Procedure or surgery | Control group, Study group |
Primary outcome
Haemoglobin level
Time frame: AFTER 12 WEEKS
Oxygen saturation measures how much hemoglobin is bound to oxygen compared to how much hemoglobin remains unbound. a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%
Asthma-related Quality of life questionnaire (AQLQ)
Time frame: AFTER 12 WEEKS
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire used to assess the physical, occupational, emotional, and social qualities of adults aged 17 to 70 years with asthma. The AQLQ has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ was developed for patients exhibiting mild to moderate asthma. The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment.
Six-minute walk test.
Time frame: AFTER 12 WEEKS
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.
Oxygen saturation
Time frame: AFTER 12 WEEKS
by using a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%. If you have a lung disease such as COPD or pneumonia, your normal oxygen saturation level may be lower.
Respiratory rate
Time frame: AFTER 12 WEEKS
The normal respiratory rate for healthy adults is between 12-20 breaths per minute. At this breathing rate, the carbon dioxide exits the lungs at the same rate that the body produces it. Breathing rates of below 12 or above 20 can mean a disruption in the breathing processes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing papworth technique and aerobic training in people with Anaemia and Asthma Exacerbations, run by Cairo University.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alaa mohamed naguib lecturer, lecturer (01092224967, Alaanaguib91@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin level (time frame: AFTER 12 WEEKS). 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 27 Dec 2024.