- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750354
Study on Effect of Papworth Technique in Anemic Asthmatic Pediatrics
A Randomized Controlled Study to Evaluate the Effect of Papworth Technique and Aerobic Training on Hemoglobin and Exercise Tolerance in Anemic Asthmatic Pediatrics
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: alaa mohamed naguib lecturer, lecturer
- Phone Number: 01092224967
- Email: Alaanaguib91@cu.edu.eg
Study Contact Backup
- Name: alshaimaa alsayed ali, lecturer
- Phone Number: 01063957095
- Email: shaimaa.ali8181@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
will receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks.
|
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 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 |
|
Active Comparator: Control group
aerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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% |
AFTER 12 WEEKS
|
|
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. |
AFTER 12 WEEKS
|
|
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.
|
AFTER 12 WEEKS
|
|
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.
|
AFTER 12 WEEKS
|
|
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.
|
AFTER 12 WEEKS
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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