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NCT Number: NCT06750354

Study on Effect of Papworth Technique 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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

papworth technique

Procedure

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

Procedure

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

Primary outcomes

  1. 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%

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

alaa mohamed naguib lecturer, lecturer

CONTACT

[email protected]

01092224967

alshaimaa alsayed ali, lecturer

CONTACT

[email protected]

01063957095

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Randomized Controlled Study to Evaluate the Effect of Papworth Technique and Aerobic Training on Hemoglobin and Exercise Tolerance in Anemic Asthmatic Pediatrics

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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