- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707611
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.
April 2, 2023 updated by: Wannaporn Tongtako, Ph.D., Chulalongkorn University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bangkok
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Pathum Wan, Bangkok, Thailand, 10330
- Faculty of Sports Science, Chulalongkorn University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Asthma, Chronic rhino-sinusitis, Hypertension, Cardiovascular diseases
- A smoking habit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Running
Running on treadmill in moderate intensity for 30 minutes
|
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.
|
|
Experimental: Cycling
Cycling on ergometer in moderate intensity for 30 minutes
|
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.
|
|
Experimental: Swimming
Swimming in moderate in tensity for 30 minutes
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Change after each exercise immediately
|
|
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
|
Change after each exercise immediately
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary functions change
Time Frame: Change after each exercise immediately
|
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.
|
Change after each exercise immediately
|
|
Respiratory muscle strength change
Time Frame: Change after each exercise immediately
|
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
|
Change after each exercise immediately
|
|
Peak nasal inspiratory flow change
Time Frame: Change after each exercise immediately
|
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.
|
Change after each exercise immediately
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tongtako 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.
- Park 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
October 15, 2022
Study Completion (Actual)
December 20, 2022
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
January 21, 2023
First Posted (Actual)
February 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 2, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX PHYSIO SPSC 3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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