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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06326632
Other study ID # RHPT/0022/023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2022
Est. completion date December 7, 2023

Study information

Verified date March 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 7, 2023
Est. primary completion date December 7, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
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.

Locations

Country Name City State
Saudi Arabia Ragab K. Elnaggar Al Kharj Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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