Precision Exercise in Obese Children With Bronchial Asthma
NCT ID: NCT07273500
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2023-09-17
2025-09-05
Brief Summary
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Pre- and post-intervention analyses included measurements of adipose-tissue- derived adipokines, circulating inflammatory markers, body composition, and pulmonary function parameters.
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
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.
Respiratory Re-training
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 group
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.
Low-dose Aerobic Training
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 150 minutes.
High-dose group
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.
High-dose Aerobic Training
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 300 minutes.
Interventions
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Respiratory Re-training
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 Training
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 150 minutes.
High-dose Aerobic Training
A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 300 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Chronic lung comorbidities
* Cardiovascular or musculoskeletal conditions expected to hinder the training.
8 Years
18 Years
ALL
No
Sponsors
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Prince Sattam Bin Abdulaziz University
OTHER
Cairo University
OTHER
Responsible Party
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Ragab Kamal Elnaggar
Professor
Locations
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Ragab K. Elnaggar
Al Kharj, Riyadh Region, Saudi Arabia
Countries
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Other Identifiers
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RHPT/0023/041
Identifier Type: -
Identifier Source: org_study_id