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Not yet recruitingNCT06750354Updated Dec 27, 2024

Study on Effect of Papworth Technique in Anemic Asthmatic Pediatrics

An interventional study of papworth technique and aerobic training in Anaemia and Asthma Exacerbations, sponsored by Cairo University. Not yet recruiting. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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

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:

  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.

02

Conditions studied

  • Anaemia
  • Asthma Exacerbations

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Keywords

  • papworth technique
  • aerobic training
  • anaemic asthmatic pediatrics
03

In context

Anemia

1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.

This study's planned enrollment of 40 is below the median of 96 across 1,318 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Study group

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

    Procedure: papworth technique · Procedure: aerobic training

  • Active comparator
    Control group

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

    Procedure: aerobic training

Interventions

  • Procedurepapworth technique

    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.

  • Procedureaerobic training

    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

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: AFTER 12 WEEKS

  2. 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.

    Time frame: AFTER 12 WEEKS

  3. 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.

    Time frame: AFTER 12 WEEKS

  4. 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.

    Time frame: AFTER 12 WEEKS

  5. 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.

    Time frame: AFTER 12 WEEKS

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Jan 2025, 0 months later.

Of 144 non-industry interventional studies with no phase under Anemia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 0 months is below that.

Counting every sponsor, half of 153 studies reached it within 19 months; a quarter within 7 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2024
First posted
Dec 27, 2024
StartEst.
Dec 20, 2024
Primary completionEst.
Jan 15, 2025
CompletionEst.
Mar 15, 2025
Last update
Dec 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06750354
Lead sponsor
Cairo University
Responsible party
Alshaimaa Alsayed Ali (lecturer of physical therapy, Cairo University) — Principal investigator
First posted
Dec 27, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
Jan 15, 2025 (estimated)
Completion
Mar 15, 2025 (estimated)
Last update
Dec 27, 2024

Study contacts

alaa mohamed naguib lecturer, lecturer
Contact
Alaanaguib91@cu.edu.eg
01092224967
alshaimaa alsayed ali, lecturer
Contact
shaimaa.ali8181@gmail.com
01063957095

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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