Allergic RhinitisNCT05707611
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.
A study testing Running, Cycling and Swimming in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Running, Cycling and Swimming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2020to 20 Dec 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of allergic rhinitis diseases
- Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
- Positive skin prick test (wheal diameter>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
- Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.
Who cannot join
- Asthma, Chronic rhino-sinusitis, Hypertension, Cardiovascular diseases
- A smoking habit
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: Acute Effects of Various Aerobic Exercise on Rhinitis Symptoms in Patients With Allergic Rhinitis.
This study was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients.
Read the detailed description
Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p < 0.05.
- Conditions
- Allergic Rhinitis
- Being tested
- Running, Cycling, Swimming
- Keywords
- Allergic rhinits, Cytokines, Aerobic exercise, Rhinitis symptoms
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RunningOther
The participant perform running on treadmill at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.
CyclingOther
The participant perform cycling on cycle ergometer at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.
SwimmingOther
The participant perform swimming at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.
| Study group | Role | What they receive |
|---|---|---|
| Running | Experimental | Running on treadmill in moderate intensity for 30 minutes Receives: Other: Running |
| Cycling | Experimental | Cycling on ergometer in moderate intensity for 30 minutes Receives: Other: Cycling |
| Swimming | Experimental | Swimming in moderate in tensity for 30 minutes Receives: Other: Swimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis symptom scores change
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 after each exercise immediately
Cytokine in nasal secretion change
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 after each exercise immediately
Secondary outcomes (3)
Pulmonary functions change
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 after each exercise immediately
Respiratory muscle strength change
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 after each exercise immediately
Peak nasal inspiratory flow change
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 after each exercise immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Aug 2020
- Primary completion15 Oct 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p \< 0.05.
- Masking
- None (open label)
- Enrolment
- 15 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707611
- Sponsor's protocol ID
- EX PHYSIO SPSC 3
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aldred S, Love JA, Tonks LA, Stephens E, Jones DS, Blannin AK. The effect of steady state exercise on circulating human IgE and IgG in young healthy volunteers with known allergy. J Sci Med Sport. 2010 Jan;13(1):16-9. doi: 10.1016/j.jsams.2008.07.001. Epub 2008 Oct 31.
PubMed 18977173Tongtako W, Klaewsongkram J, Jaronsukwimal N, Buranapraditkun S, Mickleborough TD, Suksom D. The effect of acute exhaustive and moderate intensity exercises on nasal cytokine secretion and clinical symptoms in allergic rhinitis patients. Asian Pac J Allergy Immunol. 2012 Sep;30(3):185-92.
PubMed 23156847Park J, Park JH, Park J, Choi J, Kim TH. Association between Allergic Rhinitis and Regular Physical Activity in Adults: A Nationwide Cross-Sectional Study. Int J Environ Res Public Health. 2020 Aug 5;17(16):5662. doi: 10.3390/ijerph17165662.
PubMed 32764473
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Various Aerobic Exercise on Rhinitis Symptoms in Patients With Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT05707611
- Acronym / sponsor ID
- EX PHYSIO SPSC 3
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinits, Cytokines, Aerobic exercise, Rhinitis symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 1 Feb 2023 (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 was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients.
Detailed description
Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p < 0.05.
| Arm | Type | Receives |
|---|---|---|
| Running | Experimental | Other: RunningRunning on treadmill in moderate intensity for 30 minutes |
| Cycling | Experimental | Other: CyclingCycling on ergometer in moderate intensity for 30 minutes |
| Swimming | Experimental | Other: SwimmingSwimming in moderate in tensity for 30 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of allergic rhinitis diseases
- Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
- Positive skin prick test (wheal diameter>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
- Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.
Key exclusion criteria (2 listed)
- Asthma, Chronic rhino-sinusitis, Hypertension, Cardiovascular diseases
- A smoking habit
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 |
|---|---|---|
| RunningThe participant perform running on treadmill at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. | Other | Running |
| CyclingThe participant perform cycling on cycle ergometer at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. | Other | Cycling |
| SwimmingThe participant perform swimming at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. | Other | Swimming |
Primary outcome
Rhinitis symptom scores change
Time frame: Change after each exercise immediately
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)
Cytokine in nasal secretion change
Time frame: Change after each exercise immediately
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
3 secondary outcomes
Pulmonary functions change
Time frame: Change after each exercise immediately
Respiratory muscle strength change
Time frame: Change after each exercise immediately
Peak nasal inspiratory flow change
Time frame: Change after each exercise immediately
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 5 Apr 2023.
- Results publication: PubMed 18977173Aldred S, Love JA, Tonks LA, Stephens E, Jones DS, Blannin AK. The effect of steady state exercise on circulating human IgE and IgG in young healthy volunteers with known allergy. J Sci Med Sport. 2010 Jan;13(1):16-9. doi: 10.1016/j.jsams.2008.07.001. Epub 2008 Oct 31.
- Results publication: PubMed 23156847Tongtako W, Klaewsongkram J, Jaronsukwimal N, Buranapraditkun S, Mickleborough TD, Suksom D. The effect of acute exhaustive and moderate intensity exercises on nasal cytokine secretion and clinical symptoms in allergic rhinitis patients. Asian Pac J Allergy Immunol. 2012 Sep;30(3):185-92.
- Results publication: PubMed 32764473Park J, Park JH, Park J, Choi J, Kim TH. Association between Allergic Rhinitis and Regular Physical Activity in Adults: A Nationwide Cross-Sectional Study. Int J Environ Res Public Health. 2020 Aug 5;17(16):5662. doi: 10.3390/ijerph17165662.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running, Cycling and Swimming 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 4 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 5 Apr 2023. 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 change (time frame: Change after each exercise immediately). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707611, which also lists 3 linked publications.
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 5 Apr 2023.