NCT06750354

Brief 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 . 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

26 days

First QC Date

December 16, 2024

Last Update Submit

December 24, 2024

Conditions

Keywords

papworth techniqueaerobic traininganaemic asthmatic pediatrics

Outcome Measures

Primary Outcomes (5)

  • 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%

    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.

    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.

    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.

    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.

    AFTER 12 WEEKS

Study Arms (2)

Study group

EXPERIMENTAL

will receive papworth technique and aerobic training programme in addition to medical treatment 3 sessions per week for 12 weeks.

Procedure: papworth techniqueProcedure: aerobic training

Control group

ACTIVE COMPARATOR

aerobic training programme only in addition to medical treatment3 sessions per week for 12 weeks

Procedure: aerobic training

Interventions

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.

Study group

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

Control groupStudy group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients will be included:
  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

alaa mohamed naguib lecturer, lecturer

CONTACT

alshaimaa alsayed ali, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 27, 2024

Study Start

December 20, 2024

Primary Completion

January 15, 2025

Study Completion

March 15, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share