Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma

NCT06326632 | Completed

• 1 other identifier: RHPT/0022/023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA). A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks. The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).

  3 months

Secondary Outcomes (3)

• Six-minute walk test

  3 months

• Dyspnea

  3 months

• Fatigue

  3 months

Study Arms (3)

CL-AE group

EXPERIMENTAL

The CL-AE group received a 12-week constant-load aerobic training besides the respiratory retraining program.

Other: Constant-load Aerobic Exercise

G-AE group

EXPERIMENTAL

The G-AE group received a 12-week intensity- and duration-graded aerobic training in addition to the respiratory re-training.

Other: Graded Aerobic exercise

Control group

ACTIVE COMPARATOR

The control group received the respiratory re-training only for 12 consecutive weeks.

Other: Respiratory Re-training

Interventions

Constant-load Aerobic Exercise OTHER

The CL-AE group received a 12-week aerobic training, three times in addition to the respiratory re-training. the program included a moderate-intensity aerobic training program, with an intensity set at 65% of the maximum age-predicted heart rate for 45 minutes. The training intensity and duration were maintained at the same level throughout the program. The CL-AE program included a warm-up for 5 minutes and a cool-down for 5 minutes

CL-AE group

Graded Aerobic exercise OTHER

The G-AE group received a 12-week intensity- and duration-graded aerobic training, three times in addition to the respiratory re-training. The G-AE program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. The G-AE program also included a warm-up for 5 minutes and a cool-down for 5 minutes.

G-AE group

Respiratory Re-training OTHER

The respiratory re-training lasted for 30 minutes per session and was repeated three times a week for 12 consecutive weeks. The program consisted of diaphragmatic breathing exercises, breath-hold, and breathing control exercises, pursed lip breathing, respiratory muscle strengthening, postural correction exercises, and relaxation techniques.

Control 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

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 Officials

• Ragab K. Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

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: March 17, 2024
• First Posted: March 22, 2024
• Study Start: October 30, 2022
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)