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

Constant-load Versus Graded Aerobic Exercise for Promoting Cardiorespiratory Fitness and Functional Capacity in Obese Children With Bronchial Asthma: a Randomized Comparative Effectiveness Inquiry

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.

Study Overview

• Status: Completed
• Conditions: Bronchial Asthma
• Intervention / Treatment: Other: Constant-load Aerobic Exercise; Other: Graded Aerobic exercise; Other: Respiratory Re-training

Detailed Description

Seventy-eight children with BA were recruited from the Pulmonary Medicine/Critical Care and Allergy-Immunology at King Khalid Hospital and two referral hospitals in Riyadh, Saudi Arabia. The study included children with moderate, clinically stable BA, aged 8-18 years, had a body mass index between 30 to 35 kg/m2, had no abnormalities of the lower limbs or spine, maintained constant medication dosages in the past three months, and did not engage in a regular exercise program (in the past six months). Children were excluded if they had exacerbated asthma symptoms, chronic lung comorbidities, and cardiovascular or musculoskeletal conditions expected to hinder the training.

Outcome measures

Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol.

Functional Capacity: The 6-minute walk test was used to assess the submaximal functional capacity Perceived dyspnea and fatigue: Borg's category ratio scale (CR-10) was used to explore how much dyspnea and fatigue they perceived after the 6-minute walk test.

Interventions

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.

The G-AE group received a 12-week 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.

The control group received the respiratory re-training only, 30 minutes per session, 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia
      • Ragab K. Elnaggar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CL-AE group; The CL-AE group received a 12-week constant-load aerobic training besides the respiratory retraining program.	Other: Constant-load Aerobic Exercise; 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
Experimental: G-AE group; 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; 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.
Active Comparator: Control group; The control group received the respiratory re-training only for 12 consecutive weeks.	Other: Respiratory Re-training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	This test identified the maximum distance (m) that each child was able to cover over six minutes on a straight flat 30-m walkway, without running or jogging. Walking is regarded as more efficient in line with a longer distance coverage.	3 months
Dyspnea	Dyspnea perception was assessed using Borg's category ratio scale (CR-10). Children rated the level of difficulty they experienced in breathing after completing the six-minute walk test on a 12-point scale. The scale ranges from 0 "no breathing difficulty" to 10 "maximal breathing difficulty".	3 months
Fatigue	Fatigue perception was evaluated using Borg's category ratio scale (CR-10). Children rated the level of exertion they felt after completing the six-minute walk test on a 12-point scale. The scale ranges from 0 "no fatigue" to 10 "significant fatigue".	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ragab K. Elnaggar, PhD, Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: RHPT/0022/023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No