Study on Effect of Papworth Technique in Anemic Asthmatic Pediatrics

December 24, 2024 updated by: Alshaimaa Alsayed Ali, Cairo University

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

Study Overview

Status

Not yet recruiting

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:

  1. Haemoglobin level
  2. Asthma-related Quality of life questionnaire (AQLQ)
  3. Six-minute walk test.
  4. Oxygen saturation
  5. 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:

  1. Haemoglobin level
  2. asthma-related Quality of life questionnaire (AQLQ)
  3. Six-minute walk test.
  4. Oxygen saturation
  5. 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

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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