Bronchial AsthmaNCT07273500
Precision Exercise in Obese Children With Bronchial Asthma
A study testing Respiratory Re-training, Low-dose Aerobic Training and High-dose Aerobic Training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This investigation recruited 72 pediatric patients with a confirmed bronchial asthma diagnosis. Participants were randomized into three cohorts: a control group undertaking under 75 minutes of weekly aerobic activity, a low-dose group completing 150 minutes/week, and a high-dose group performing 300 minutes/week. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Respiratory Re-training, Low-dose Aerobic Training and High-dose Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Sep 2023to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of 8-18 years
- Body mass index ranging from 30 to 35 kg/m2
- Verified asthma diagnosis per the Global Initiative for Asthma (GINA) criteria
- Moderate Onset
- Clinically Stable
- Maintained medication dosages in the past three months
- Free of lower limb or spinal deformities
- Not engaging in regular exercise regimens in the past six months.
Who cannot join
- Exacerbated asthma symptoms
- Chronic lung comorbidities
- Cardiovascular or musculoskeletal conditions expected to hinder the training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precision Exercise Prescription for Obese Children With Bronchial Asthma: a Dose-dependent Study on Adiposity Biomarkers, Body Composition, and Respiratory Efficiency
This investigation recruited 72 pediatric patients with a confirmed bronchial asthma diagnosis. Participants were randomized into three cohorts: a control group undertaking under 75 minutes of weekly aerobic activity, a low-dose group completing 150 minutes/week, and a high-dose group performing 300 minutes/week. Exercise intensity was maintained between 50-70% of the age- adjusted maximum heart rate across 3-4 supervised sessions per week for a 12-week intervention period.
Pre- and post-intervention analyses included measurements of adipose-tissue- derived adipokines, circulating inflammatory markers, body composition, and pulmonary function parameters.
Read the detailed description
Study Population and Recruitment
A total of 72 pediatric patients with bronchial asthma were enrolled from the Pulmonary Medicine/Critical Care and Allergy-Immunology departments of King Khalid Hospital and two additional tertiary care centers in Riyadh, Saudi Arabia. Eligible participants were children aged 8 to 18 years with a diagnosis of moderate, clinically stable BA and a body mass index ranging from 30.0 to 35.0 kg/m². Further inclusion criteria stipulated the absence of lower limb or spinal deformities, stable medication regimens for the preceding three months, and no participation in structured physical activity for at least six months prior to the study. Exclusion criteria encompassed acute exacerbation of asthma symptoms, the presence of other chronic pulmonary diseases, and any pre- existing cardiovascular or musculoskeletal disorder that could impede exercise training.
Outcome Measures
Adiposity and Inflammatory Biomarkers: Serum concentrations of key adipokines-specifically total adiponectin, high-molecular-weight adiponectin, leptin, and resistin-were analyzed. Concurrently, systemic inflammatory mediators, including interleukin-6 and high-sensitivity C-reactive protein, were quantified using commercially available enzyme-linked immunosorbent assay kits.
Body Composition Analysis: A multi-frequency bioelectrical impedance analysis (BIA) device was employed to determine body composition indices. The parameters assessed included body fat percentage, fat mass, fat-free mass, total body water, and basal metabolic rate.
Pulmonary Function Testing: Spirometric evaluations were conducted with a calibrated spirometer to measure forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). The FEV1/FVC ratio was subsequently calculated from these values.
Intervention Protocol
All participants underwent a standardized respiratory re-training program for 12 consecutive weeks. This intervention was administered in 30-minute sessions, three times per week, and comprised diaphragmatic breathing, breath-holding and control exercises, pursed-lip breathing, inspiratory muscle strengthening, postural correction, and relaxation techniques.
Participants were then allocated into three distinct groups, each receiving an additional, varying dose of aerobic training superimposed on the core respiratory program:
Control Group: This group performed supplemental aerobic exercise at a moderate intensity (50-70% of age-predicted maximum heart rate) for a consistent total of less than 75 minutes per week, spread across three sessions.
Low-Dose Group: This cohort engaged in aerobic training at the same moderate intensity, with a target cumulative duration of 150 minutes per week. The duration was progressively increased from a baseline of 90 minutes in the first week by 30 minutes each subsequent week, stabilizing at the target dose by the third week.
High-Dose Group: This group followed the same moderate-intensity aerobic protocol but with a target weekly volume of 300 minutes. A similar progressive ramp-up was implemented, starting at 90 minutes weekly and increasing by 30 minutes per week until the target was achieved in the eighth week, after which it was maintained.
- Conditions
- Bronchial Asthma
- Being tested
- Respiratory Re-training, Low-dose Aerobic Training, High-dose Aerobic Training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Re-trainingOther
The standardized respiratory re-training protocol was administered in 30-minute sessions, three times per week, over a consecutive 12-week period. The regimen incorporated diaphragmatic breathing, breath-holding and control techniques, pursed-lip breathing, respiratory muscle strengthening, postural correction, and relaxation exercises.
Low-dose Aerobic TrainingOther
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 150 minutes.
High-dose Aerobic TrainingOther
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 300 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group completed the 12-week respiratory re-training program alongside a moderate-intensity aerobic regimen (50-70% of maximum heart rate), maintaining a total weekly exercise volume not exceeding 75 minutes. Receives: Other: Respiratory Re-training |
| Low-dose group | Experimental | For the low-dose condition, participants engaged in the standard respiratory re training and supplemental aerobic exercise at 50-70% of maximum heart rate, capping the cumulative weekly duration at 150 minutes across the 12-week intervention. Receives: Other: Low-dose Aerobic Training |
| High-dose group | Experimental | The high-dose group performed the core respiratory re-training in addition to a moderate-intensity aerobic regimen (50-70% of maximum heart rate), which was systematically escalated to a maintenance volume of 300 minutes per week throughout the 12-week trial. Receives: Other: High-dose Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin
Serum leptin concentration was evaluated as a primary adipokine. It was assayed using a commercially available enzyme-linked immunosorbent assay kit, with pre- and post-training results expressed in nanograms per milliliter (ng/mL).
Measured: 2 months
Total Adiponectin
Serum total adiponectin concentration was quantified as a key adiposity biomarker, pre- and post-training. It was measured using a commercially available enzyme-linked immunosorbent assay kit, with results reported in micrograms per milliliter (µg/mL)
Measured: 2 months
High-molecular-weight Adiponectin
The serum concentration of the high-molecular-weight isoform of adiponectin was analyzed pre- and post-training. It was quantified using a commercial enzyme-linked immunosorbent assay, with levels reported in micrograms per milliliter (µg/mL).
Measured: 2 months
Resistin
Serum resistin concentration was assessed as an adipokine of interest. Levels were determined from pre- and post-training blood samples using a commercial enzyme-linked immunosorbent assay kit, with concentrations reported in nanograms per milliliter (ng/mL).
Measured: 2 months
Interleukin-6
Systemic concentration of the inflammatory cytokine interleukin 6 was evaluated. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in picograms per milliliter (pg/mL).
Measured: 2 months
High-sensitivity C-reactive protein
Systemic concentration of high-sensitivity C-reactive protein was assessed as a marker of low-grade inflammation. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in milligrams per liter (mg/L).
Measured: 2 months
Body fat percentage
Body fat percentage was evaluated as a key body composition metric. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed as a percentage (%).
Measured: 2 months
Fat Mass
Total body fat mass was assessed as a component of body composition. It was measured pre- and post-intervention using a bioelectrical impedance analysis device, with values reported in kilograms (kg).
Measured: 2 months
Fat-free mass
Fat-free mass was evaluated as an indicator of lean body tissue. Pre- and post-training measurements were obtained using a bioelectrical impedance analysis device, with results recorded in kilograms (kg).
Measured: 2 months
Total body water
Total body water was quantified as a fundamental body composition parameter. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed in liters (L).
Measured: 2 months
Basal Metabolic Rate
Basal metabolic rate was estimated as a measure of resting energy expenditure. Pre- and post-training assessments were conducted using a bioelectrical impedance analysis device, with results reported in kilocalories per day (kcal/day).
Measured: 2 months
Forced Expiratory Volume in One Second
Forced expiratory volume in one second (FEV#) was assessed as a primary spirometric parameter of airway function. Pre- and post-training measurements were obtained using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred) based on established reference standards.
Measured: 2 months
Forced Vital Capacity
Forced vital capacity (FVC) was evaluated as a key measure of lung volume. Pre- and post-training assessments were performed using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred).
Measured: 2 months
Forced Expiratory Volume in One Second (FEV1) / Forced Vital Capacity (FVC) Ratio
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) was calculated as an indicator of airflow limitation. This derived value was determined from pre- and post-training spirometric maneuvers and is expressed as a ratio (decimal value).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start17 Sep 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273500
- Sponsor's protocol ID
- RHPT/0023/041
- Status last verified
- Oct 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Exercise Prescription for Obese Children With Bronchial Asthma: a Dose-dependent Study on Adiposity Biomarkers, Body Composition, and Respiratory Efficiency
- ClinicalTrials.gov ID
- NCT07273500
- Acronym / sponsor ID
- RHPT/0023/041
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation recruited 72 pediatric patients with a confirmed bronchial asthma diagnosis. Participants were randomized into three cohorts: a control group undertaking under 75 minutes of weekly aerobic activity, a low-dose group completing 150 minutes/week, and a high-dose group performing 300 minutes/week. Exercise intensity was maintained between 50-70% of the age- adjusted maximum heart rate across 3-4 supervised sessions per week for a 12-week intervention period.
Pre- and post-intervention analyses included measurements of adipose-tissue- derived adipokines, circulating inflammatory markers, body composition, and pulmonary function parameters.
Detailed description
Study Population and Recruitment
A total of 72 pediatric patients with bronchial asthma were enrolled from the Pulmonary Medicine/Critical Care and Allergy-Immunology departments of King Khalid Hospital and two additional tertiary care centers in Riyadh, Saudi Arabia. Eligible participants were children aged 8 to 18 years with a diagnosis of moderate, clinically stable BA and a body mass index ranging from 30.0 to 35.0 kg/m². Further inclusion criteria stipulated the absence of lower limb or spinal deformities, stable medication regimens for the preceding three months, and no participation in structured physical activity for at least six months prior to the study. Exclusion criteria encompassed acute exacerbation of asthma symptoms, the presence of other chronic pulmonary diseases, and any pre- existing cardiovascular or musculoskeletal disorder that could impede exercise training.
Outcome Measures
Adiposity and Inflammatory Biomarkers: Serum concentrations of key adipokines-specifically total adiponectin, high-molecular-weight adiponectin, leptin, and resistin-were analyzed. Concurrently, systemic inflammatory mediators, including interleukin-6 and high-sensitivity C-reactive protein, were quantified using commercially available enzyme-linked immunosorbent assay kits.
Body Composition Analysis: A multi-frequency bioelectrical impedance analysis (BIA) device was employed to determine body composition indices. The parameters assessed included body fat percentage, fat mass, fat-free mass, total body water, and basal metabolic rate.
Pulmonary Function Testing: Spirometric evaluations were conducted with a calibrated spirometer to measure forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). The FEV1/FVC ratio was subsequently calculated from these values.
Intervention Protocol
All participants underwent a standardized respiratory re-training program for 12 consecutive weeks. This intervention was administered in 30-minute sessions, three times per week, and comprised diaphragmatic breathing, breath-holding and control exercises, pursed-lip breathing, inspiratory muscle strengthening, postural correction, and relaxation techniques.
Participants were then allocated into three distinct groups, each receiving an additional, varying dose of aerobic training superimposed on the core respiratory program:
Control Group: This group performed supplemental aerobic exercise at a moderate intensity (50-70% of age-predicted maximum heart rate) for a consistent total of less than 75 minutes per week, spread across three sessions.
Low-Dose Group: This cohort engaged in aerobic training at the same moderate intensity, with a target cumulative duration of 150 minutes per week. The duration was progressively increased from a baseline of 90 minutes in the first week by 30 minutes each subsequent week, stabilizing at the target dose by the third week.
High-Dose Group: This group followed the same moderate-intensity aerobic protocol but with a target weekly volume of 300 minutes. A similar progressive ramp-up was implemented, starting at 90 minutes weekly and increasing by 30 minutes per week until the target was achieved in the eighth week, after which it was maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, three-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Respiratory Re-trainingThe control group completed the 12-week respiratory re-training program alongside a moderate-intensity aerobic regimen (50-70% of maximum heart rate), maintaining a total weekly exercise volume not exceeding 75 minutes. |
| Low-dose group | Experimental | Other: Low-dose Aerobic TrainingFor the low-dose condition, participants engaged in the standard respiratory re training and supplemental aerobic exercise at 50-70% of maximum heart rate, capping the cumulative weekly duration at 150 minutes across the 12-week intervention. |
| High-dose group | Experimental | Other: High-dose Aerobic TrainingThe high-dose group performed the core respiratory re-training in addition to a moderate-intensity aerobic regimen (50-70% of maximum heart rate), which was systematically escalated to a maintenance volume of 300 minutes per week throughout the 12-week trial. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age of 8-18 years
- Body mass index ranging from 30 to 35 kg/m2
- Verified asthma diagnosis per the Global Initiative for Asthma (GINA) criteria
- Moderate Onset
- Clinically Stable
Key exclusion criteria (3 listed)
- Exacerbated asthma symptoms
- Chronic lung comorbidities
- Cardiovascular or musculoskeletal conditions expected to hinder the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Re-trainingThe standardized respiratory re-training protocol was administered in 30-minute sessions, three times per week, over a consecutive 12-week period. The regimen incorporated diaphragmatic breathing, breath-holding and control techniques, pursed-lip breathing, respiratory muscle strengthening, postural correction, and relaxation exercises. | Other | Control group |
| Low-dose Aerobic TrainingA moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 150 minutes. | Other | Low-dose group |
| High-dose Aerobic TrainingA moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 300 minutes. | Other | High-dose group |
Primary outcome
Leptin
Time frame: 2 months
Serum leptin concentration was evaluated as a primary adipokine. It was assayed using a commercially available enzyme-linked immunosorbent assay kit, with pre- and post-training results expressed in nanograms per milliliter (ng/mL).
Total Adiponectin
Time frame: 2 months
Serum total adiponectin concentration was quantified as a key adiposity biomarker, pre- and post-training. It was measured using a commercially available enzyme-linked immunosorbent assay kit, with results reported in micrograms per milliliter (µg/mL)
High-molecular-weight Adiponectin
Time frame: 2 months
The serum concentration of the high-molecular-weight isoform of adiponectin was analyzed pre- and post-training. It was quantified using a commercial enzyme-linked immunosorbent assay, with levels reported in micrograms per milliliter (µg/mL).
Resistin
Time frame: 2 months
Serum resistin concentration was assessed as an adipokine of interest. Levels were determined from pre- and post-training blood samples using a commercial enzyme-linked immunosorbent assay kit, with concentrations reported in nanograms per milliliter (ng/mL).
Interleukin-6
Time frame: 2 months
Systemic concentration of the inflammatory cytokine interleukin 6 was evaluated. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in picograms per milliliter (pg/mL).
High-sensitivity C-reactive protein
Time frame: 2 months
Systemic concentration of high-sensitivity C-reactive protein was assessed as a marker of low-grade inflammation. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in milligrams per liter (mg/L).
Body fat percentage
Time frame: 2 months
Body fat percentage was evaluated as a key body composition metric. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed as a percentage (%).
Fat Mass
Time frame: 2 months
Total body fat mass was assessed as a component of body composition. It was measured pre- and post-intervention using a bioelectrical impedance analysis device, with values reported in kilograms (kg).
Fat-free mass
Time frame: 2 months
Fat-free mass was evaluated as an indicator of lean body tissue. Pre- and post-training measurements were obtained using a bioelectrical impedance analysis device, with results recorded in kilograms (kg).
Total body water
Time frame: 2 months
Total body water was quantified as a fundamental body composition parameter. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed in liters (L).
Basal Metabolic Rate
Time frame: 2 months
Basal metabolic rate was estimated as a measure of resting energy expenditure. Pre- and post-training assessments were conducted using a bioelectrical impedance analysis device, with results reported in kilocalories per day (kcal/day).
Forced Expiratory Volume in One Second
Time frame: 2 months
Forced expiratory volume in one second (FEV#) was assessed as a primary spirometric parameter of airway function. Pre- and post-training measurements were obtained using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred) based on established reference standards.
Forced Vital Capacity
Time frame: 2 months
Forced vital capacity (FVC) was evaluated as a key measure of lung volume. Pre- and post-training assessments were performed using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred).
Forced Expiratory Volume in One Second (FEV1) / Forced Vital Capacity (FVC) Ratio
Time frame: 2 months
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) was calculated as an indicator of airflow limitation. This derived value was determined from pre- and post-training spirometric maneuvers and is expressed as a ratio (decimal value).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Re-training, Low-dose Aerobic Training and High-dose Aerobic Training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin (time frame: 2 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.