Back to resultsAcute Effects of Various Aerobic Exercise in Allergic Rhinitis.
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Running
Cycling
Swimming
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinits, Cytokines, Aerobic exercise, Rhinitis symptoms
Eligibility Criteria
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
Sites / Locations
- Faculty of Sports Science, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Running
Cycling
Swimming
Arm Description
Running on treadmill in moderate intensity for 30 minutes
Cycling on ergometer in moderate intensity for 30 minutes
Swimming in moderate in tensity for 30 minutes
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT05707611
First Posted
January 12, 2023
Last Updated
April 2, 2023
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT05707611
Brief Title
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.
Official Title
Acute Effects of Various Aerobic Exercise on Rhinitis Symptoms in Patients With Allergic Rhinitis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic rhinits, Cytokines, Aerobic exercise, Rhinitis symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Running
Arm Type
Experimental
Arm Description
Running on treadmill in moderate intensity for 30 minutes
Arm Title
Cycling
Arm Type
Experimental
Arm Description
Cycling on ergometer in moderate intensity for 30 minutes
Arm Title
Swimming
Arm Type
Experimental
Arm Description
Swimming in moderate in tensity for 30 minutes
Intervention Type
Other
Intervention Name(s)
Running
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cycling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Swimming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rhinitis symptom scores change
Description
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)
Time Frame
Change after each exercise immediately
Title
Cytokine in nasal secretion change
Description
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
Time Frame
Change after each exercise immediately
Secondary Outcome Measure Information:
Title
Pulmonary functions change
Description
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.
Time Frame
Change after each exercise immediately
Title
Respiratory muscle strength change
Description
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
Time Frame
Change after each exercise immediately
Title
Peak nasal inspiratory flow change
Description
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.
Time Frame
Change after each exercise immediately
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
18977173
Citation
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.
Results Reference
result
PubMed Identifier
23156847
Citation
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.
Results Reference
result
PubMed Identifier
32764473
Citation
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.
Results Reference
result
Learn more about this trial
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.
We'll reach out to this number within 24 hrs