Precision Exercise in Obese Children With Bronchial Asthma

NCT07273500 | Completed

• 1 other identifier: RHPT/0023/041
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (14)

• 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).

  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)

  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).

  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).

  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).

  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).

  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 (%).

  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).

  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).

  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).

  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).

  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.

  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).

  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).

  2 months

Study Arms (3)

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.

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.

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.

Other: High-dose Aerobic Training

Interventions

Respiratory Re-training OTHER

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.

Control group

Low-dose Aerobic Training OTHER

A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 150 minutes.

Low-dose group

High-dose Aerobic Training OTHER

A moderate-intensity aerobic regimen (50-70% of maximum heart rate) maintained at a consistent total weekly volume of 300 minutes.

High-dose group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Exacerbated asthma symptoms
• Chronic lung comorbidities
• Cardiovascular or musculoskeletal conditions expected to hinder the training.

Sponsors & Collaborators

• Cairo University: lead
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, three-arm, randomized controlled trial

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: September 17, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)