Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-14 @ 1:26 AM
Study NCT ID:
NCT07273500
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Exercise in Obese Children With Bronchial Asthma
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Precision Exercise Prescription for Obese Children With Bronchial Asthma: a Dose-dependent Study on Adiposity Biomarkers, Body Composition, and Respiratory Efficiency
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: