Bronchial AsthmaNCT06326632
Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma
A study testing Constant-load Aerobic Exercise, Graded Aerobic exercise and Respiratory Re-training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
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). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Constant-load Aerobic Exercise, Graded Aerobic exercise and Respiratory Re-training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Oct 2022to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Exacerbated asthma symptoms
- Chronic lung comorbidities
- Cardiovascular or musculoskeletal conditions expected to hinder the training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- Constant-load Aerobic Exercise, Graded Aerobic exercise, Respiratory Re-training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant-load Aerobic ExerciseOther
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 exerciseOther
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-trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CL-AE group | Experimental | The CL-AE group received a 12-week constant-load aerobic training besides the respiratory retraining program. Receives: 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. Receives: Other: Graded Aerobic exercise |
| Control group | Active comparator | The control group received the respiratory re-training only for 12 consecutive weeks. Receives: Other: Respiratory Re-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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".
Measured: 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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start30 Oct 2022
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K. Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326632
- Sponsor's protocol ID
- RHPT/0022/023
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constant-load Versus Graded Aerobic Exercise for Promoting Cardiorespiratory Fitness and Functional Capacity in Obese Children With Bronchial Asthma: a Randomized Comparative Effectiveness Inquiry
- ClinicalTrials.gov ID
- NCT06326632
- Acronym / sponsor ID
- RHPT/0022/023
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, three-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| CL-AE group | Experimental | Other: Constant-load Aerobic ExerciseThe CL-AE group received a 12-week constant-load aerobic training besides the respiratory retraining program. |
| G-AE group | Experimental | Other: Graded Aerobic exerciseThe G-AE group received a 12-week intensity- and duration-graded aerobic training in addition to the respiratory re-training. |
| Control group | Active comparator | Other: Respiratory Re-trainingThe control group received the respiratory re-training only for 12 consecutive weeks. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Exacerbated asthma symptoms
- Chronic lung comorbidities
- Cardiovascular or musculoskeletal conditions expected to hinder the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constant-load Aerobic ExerciseThe 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 | Other | CL-AE group |
| Graded Aerobic exerciseThe 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. | Other | G-AE group |
| Respiratory Re-trainingThe 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. | Other | Control group |
Primary outcome
Peak oxygen uptake
Time frame: 3 months
The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).
3 secondary outcomes
Six-minute walk test
Time frame: 3 months
Dyspnea
Time frame: 3 months
Fatigue
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchial Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K. Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant-load Aerobic Exercise, Graded Aerobic exercise and Respiratory Re-training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.