Allergic RhinitisNCT06543251
Effect of High Intensity Interval Exercise Training in Patients With Allergic Rhinitis
A study testing High-intensity interval training group (HIIT) and Moderate continuous training group (MCT) in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The objective of this study was to compare the effects of training between high-intensity interval training and moderate continuous exercise training on the pulmonary function, respiratory muscle strength, symptoms of patients with allergic rhinitis, cytokines, and oxidative stress in patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- High-intensity interval training group (HIIT) and Moderate continuous training group (MCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2023to 15 Oct 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A patient with allergic rhinitis who underwent a skin prick test and received a positive result.
- Patients with persistent allergic rhinitis, male and female, with symptoms of nasal congestion, sneezing, nasal itching, and runny nose for more than 4 days per week, and an average score of 7 or more in the past week using the allergic rhinitis symptom assessment questionnaire.
- stopped taking all medicine before the study such as antihistamine for 3 days, oral steroid and nasal steroid for at least 2 weeks and leukotriene receptor antagonist for at least a week prior to the study
- had no exercise program, non-smoking and without any food supplementation for at least 6 months prior to the start of the study
- Must not have other respiratory diseases such as bronchitis, pertussis, pneumonia, pneumonitis, aspergilloma, tuberculosis, asthma, lung cancer, emphysema, etc.
- Have a body mass index (BMI) between 18.5 and 24.9 kg/m².
- Complete the Physical Activity Readiness Questionnaire (PAR-Q+) by answering "no" to all questions.
Who cannot join
- There is an unforeseen circumstance, such as an illness, that prevents participation in the research.
- Less than 80% of the research was completed.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Pathum Wan, Bangkok, 10330
About this study
Official title: The Effects of Training Between High-Intensity Interval and Moderate Continuous Exercise on Respiratory Function and Rhinitis Symptoms in Patients With Allergic Rhinitis.
The objective of this study was to compare the effects of training between high-intensity interval training and moderate continuous exercise training on the pulmonary function, respiratory muscle strength, symptoms of patients with allergic rhinitis, cytokines, and oxidative stress in patients with allergic rhinitis.
Read the detailed description
36 patients with allergic rhinitis were divided into 3 groups, 12 people per group: the control group (CON), the group with high-intensity interval training at a ratio of 1:2 (HIIT) and the group with moderate continuous training (MCT), 3 days per week, over a total period of 12 weeks. Before and after the experiment, lung function, respiratory muscle strength, allergic rhinitis symptoms, nasal blood flow rate, peak nasal inspiratory flow, nitric oxide levels, cytokines and quality of life were measured and used for statistical analysis.
- Conditions
- Allergic Rhinitis
- Being tested
- High-intensity interval training group (HIIT), Moderate continuous training group (MCT), Sedentary control group (CON)
- Keywords
- Allergic rhinitis, Aerobic exercise, High intensity interval training, pulmonary function, cytokines
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training group (HIIT)Other
The participants performed HIIT programs for 12 weeks involving walking/running on a treadmill preceded by a 10-min warm-up at low intensity and exercise with high intensity for 1 min at 85%-90% of the maximum heart rate alternating with low intensity at 50%-55% of the maximum heart rate for 2 min, for 24 minutes, and 10-min cool down.
Moderate continuous training group (MCT)Other
Subject participating in 30-min sessions for 12 weeks and Each session consisted of a 10-min warm up, walking/running on a treadmill 30 minutes at 65-70% Maximum Heart rate and 10-min cool down.
Sedentary control group (CON)Other
The control group had normal daily life.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training group (HIIT) | Experimental | the group with high-intensity interval training at a ratio of 1:2 (HIIT) 3 days per week, over a total period of 12 weeks. Receives: Other: High-intensity interval training group (HIIT) |
| Moderate continuous training group (MCT) | Experimental | the group with moderate continuous training, 3 days per week, over a total period of 12 weeks. Receives: Other: Moderate continuous training group (MCT) |
| Sedentary control group (CON) | Other | Not described Receives: Other: Sedentary control group (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis symptom scores
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)
Measured: Change from Baseline Rhinitis symptom scores at 12 weeks.
Peak nasal inspiratory flow
The subjects placed a mask, which is turned onto a plastic cylinder through which the air passes during inspiration, over the nose and mouth and inspired forcefully through the nose, with lips tightly closed. Inside the cylinder, there is a diaphragm that moves to the airflow, and the maximum peak flow is registered in a scale range from 30-370 L/min. During the procedure, the subjects placed a mask over the nose and mouth and inspired forcefully through the nose, with lips tightly closed.
Measured: Change from Baseline Peak nasal inspiratory flow scores at 12 weeks.
Nasal blood flow
Laser Doppler flowmetry (DRT4 moor instrument, UK.) was used to measure of the nasal blood flow (NBF). Before the test each subject rested for one hour in a separate room. During the test, they were instructed to breathe normally breathe and not to speak, cough, or move. A lateral endoscopic probe with a flexible nylon sheath 1.34-mm-diameter flexible nylon sheath was placed to the front of the nose.
Measured: Change from Baseline Nasal blood flow scores at 12 weeks.
Pulmonary Functions
The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration.
Measured: Change from Baseline Pulmonary Functions at 12 weeks.
Respiratory muscle strength
Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity [FRC] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity [TLC] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds
Measured: Change from Baseline Respiratory muscle strength at 12 weeks.
Fraction exhaled nitric oxide
Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.
Measured: Change from Baseline Fraction exhaled nitric oxide at 12 weeks.
Aerobic capacity
Aerobic capacity variables were measured by determining maximum oxygen uptake (VO2max) using the Bruce protocol. The subjects ran on a treadmill. At the beginning of the test, the baseline or resting value was collected for the first 3 minutes. The initial speed was set at step 1 (minutes 0-3) at a speed of 1.7 mph with a 10% incline. The test was incremented every 3 minutes. Step 2 (minutes 4-6) was conducted at a speed of 2.5 mph with a 2% incline. The test continued until the subjects could not run any further. Following this, the subjects were cooled down for 3 minutes. The maximum oxygen uptake was measured in milliliters per kilogram per minute (ml/kg/min).
Measured: Change from Baseline Aerobic capacity at 12 weeks.
Secondary outcomes (2)
Cytokine in nasal secretion
Nasal secretions collection was performed bilaterally with filter paper strips (7x30 mm Whatman No.42, Whatman, Clifton, NJ). Three filter paper strips were sequentially placed on each anterior portion of the inferior turbinate for 10 min. This filter paper strips were collected into appropriate tubes and centrifuged at 3,000 rpm for 5 min at 4 °C and immediately frozen at -70 °C until later analysis.The levels of cytokines were determined by using Sandwich ELISA technique
Measured: Change from Baseline Cytokine in nasal secretion at 12 weeks.
Rhinoconjunctivitis quality of life questionnaire - 36; Rcq-36
The quality of life of individuals with allergic rhinitis was assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (Rcq-36). The researcher distributed the questionnaire and asked the participants to fill it out themselves.
Measured: Change from Baseline quality of life at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jun 2023
- Primary completion25 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wannaporn Tongtako, Ph.D., Chulalongkorn University
- Investigators
- Wannaporn Tongtako, Ph.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543251
- Sponsor's protocol ID
- EX PHYSIO SPSC 11
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Training Between High-Intensity Interval and Moderate Continuous Exercise on Respiratory Function and Rhinitis Symptoms in Patients With Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT06543251
- Acronym / sponsor ID
- EX PHYSIO SPSC 11
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Aerobic exercise, High intensity interval training, pulmonary function, cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 7 Aug 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.
The objective of this study was to compare the effects of training between high-intensity interval training and moderate continuous exercise training on the pulmonary function, respiratory muscle strength, symptoms of patients with allergic rhinitis, cytokines, and oxidative stress in patients with allergic rhinitis.
Detailed description
36 patients with allergic rhinitis were divided into 3 groups, 12 people per group: the control group (CON), the group with high-intensity interval training at a ratio of 1:2 (HIIT) and the group with moderate continuous training (MCT), 3 days per week, over a total period of 12 weeks. Before and after the experiment, lung function, respiratory muscle strength, allergic rhinitis symptoms, nasal blood flow rate, peak nasal inspiratory flow, nitric oxide levels, cytokines and quality of life were measured and used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training group (HIIT) | Experimental | Other: High-intensity interval training group (HIIT)the group with high-intensity interval training at a ratio of 1:2 (HIIT) 3 days per week, over a total period of 12 weeks. |
| Moderate continuous training group (MCT) | Experimental | Other: Moderate continuous training group (MCT)the group with moderate continuous training, 3 days per week, over a total period of 12 weeks. |
| Sedentary control group (CON) | Other | Other: Sedentary control group (CON) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A patient with allergic rhinitis who underwent a skin prick test and received a positive result.
- Patients with persistent allergic rhinitis, male and female, with symptoms of nasal congestion, sneezing, nasal itching, and runny nose for more than 4 days per week, and an average score of 7 or more in the past week using the allergic rhinitis symptom assessment questionnaire.
- stopped taking all medicine before the study such as antihistamine for 3 days, oral steroid and nasal steroid for at least 2 weeks and leukotriene receptor antagonist for at least a week prior to the study
- had no exercise program, non-smoking and without any food supplementation for at least 6 months prior to the start of the study
- Must not have other respiratory diseases such as bronchitis, pertussis, pneumonia, pneumonitis, aspergilloma, tuberculosis, asthma, lung cancer, emphysema, etc.
Key exclusion criteria (2 listed)
- There is an unforeseen circumstance, such as an illness, that prevents participation in the research.
- Less than 80% of the research was completed.
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 |
|---|---|---|
| High-intensity interval training group (HIIT)The participants performed HIIT programs for 12 weeks involving walking/running on a treadmill preceded by a 10-min warm-up at low intensity and exercise with high intensity for 1 min at 85%-90% of the maximum heart rate alternating with low intensity at 50%-55% of the maximum heart rate for 2 min, for 24 minutes, and 10-min cool down. | Other | High-intensity interval training group (HIIT) |
| Moderate continuous training group (MCT)Subject participating in 30-min sessions for 12 weeks and Each session consisted of a 10-min warm up, walking/running on a treadmill 30 minutes at 65-70% Maximum Heart rate and 10-min cool down. | Other | Moderate continuous training group (MCT) |
| Sedentary control group (CON)The control group had normal daily life. | Other | Sedentary control group (CON) |
Primary outcome
Rhinitis symptom scores
Time frame: Change from Baseline Rhinitis symptom scores at 12 weeks.
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)
Peak nasal inspiratory flow
Time frame: Change from Baseline Peak nasal inspiratory flow scores at 12 weeks.
The subjects placed a mask, which is turned onto a plastic cylinder through which the air passes during inspiration, over the nose and mouth and inspired forcefully through the nose, with lips tightly closed. Inside the cylinder, there is a diaphragm that moves to the airflow, and the maximum peak flow is registered in a scale range from 30-370 L/min. During the procedure, the subjects placed a mask over the nose and mouth and inspired forcefully through the nose, with lips tightly closed.
Nasal blood flow
Time frame: Change from Baseline Nasal blood flow scores at 12 weeks.
Laser Doppler flowmetry (DRT4 moor instrument, UK.) was used to measure of the nasal blood flow (NBF). Before the test each subject rested for one hour in a separate room. During the test, they were instructed to breathe normally breathe and not to speak, cough, or move. A lateral endoscopic probe with a flexible nylon sheath 1.34-mm-diameter flexible nylon sheath was placed to the front of the nose.
Pulmonary Functions
Time frame: Change from Baseline Pulmonary Functions at 12 weeks.
The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration.
Respiratory muscle strength
Time frame: Change from Baseline Respiratory muscle strength at 12 weeks.
Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity [FRC] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity [TLC] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds
Fraction exhaled nitric oxide
Time frame: Change from Baseline Fraction exhaled nitric oxide at 12 weeks.
Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.
Aerobic capacity
Time frame: Change from Baseline Aerobic capacity at 12 weeks.
Aerobic capacity variables were measured by determining maximum oxygen uptake (VO2max) using the Bruce protocol. The subjects ran on a treadmill. At the beginning of the test, the baseline or resting value was collected for the first 3 minutes. The initial speed was set at step 1 (minutes 0-3) at a speed of 1.7 mph with a 10% incline. The test was incremented every 3 minutes. Step 2 (minutes 4-6) was conducted at a speed of 2.5 mph with a 2% incline. The test continued until the subjects could not run any further. Following this, the subjects were cooled down for 3 minutes. The maximum oxygen uptake was measured in milliliters per kilogram per minute (ml/kg/min).
2 secondary outcomes
Cytokine in nasal secretion
Time frame: Change from Baseline Cytokine in nasal secretion at 12 weeks.
Rhinoconjunctivitis quality of life questionnaire - 36; Rcq-36
Time frame: Change from Baseline quality of life at 12 weeks.
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 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Wannaporn Tongtako, Ph.D. principal investigator
Chulalongkorn 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 High-intensity interval training group (HIIT) and Moderate continuous training group (MCT) in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
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 7 inclusion and 2 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 7 Aug 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 Thailand. 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?
Rhinitis symptom scores (time frame: Change from Baseline Rhinitis symptom scores at 12 weeks.). The study lists 7 primary outcomes in all. 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 7 Aug 2024.