- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05779046
Acute Effect of High Intensity Interval Exercise in Patients With Allergic Rhinitis
March 20, 2023 updated by: Wannaporn Tongtako, Ph.D., Chulalongkorn University
The Acute Effect of High Intensity Interval Exercise on Respiratory Function and Rhinitis Symptoms in Patients With Allergic Rhinitis
The purpose of this study was to determine the acute effect of high intensity interval exercise on respiratory function and rhinitis symptoms in allergic rhinitis patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Twelve patients with allergic rhinitis aged between 19 and 31 years who had a positive skin prick test to house dust mite (D. pteronyssinus).
The experiment was a crossover design in which each participant was given two types of high-intensity interval training exercise (HIT): HIT 1:1 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternating with low intensity 50-55% of maximum heart rate for 1 minute) and HIT 1:2 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternating with low intensity 50-55% of maximum heart rate for 2 minutes).
Rhinitis symptoms, nasal blood flow, peak nasal inspiratory flow, pulmonary functions, respiratory muscle strength, and fractional exhaled nitric oxide were measured before and immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after exercise for each exercise program.
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects had a clinical history of persistent rhinitis, and had positive skin prick test to house dust mite (D. pteronyssinus)
- Persistent allergic rhinitis
- Subjects with known asthma, chronic rhinosinusitis, Lung cancer and Emphysema diseases were excluded.
- BMI 18.5 - 24.9 kg/m2
- Subjects will ask to abstain from taking antihistamine for at least 5 days, leukotriene receptor antagonist for at least 1 week, and nasal steroids for at least 2 weeks prior to the start of the experiment.
- Subjects will ask to abstain from taking any form of dietary supplement during the experiment.
- Subjects had no exercise training program (not exercise regularly or not exercise for 30 minutes or more at least 3 times per week during the past 6 months)
Exclusion Criteria:
- Accident that are unable to continue the research, such as accidental injury or illness, etc.
- Participants did not voluntarily participate.
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: HIT 1:1
The participants received a high-intensity interval exercise program of walking or running on a treadmill for approximately 40 minutes.
The training included a 10-minute warm-up at low intensity.
High-intensity interval exercise at a ratio of 1:1 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternating with low intensity 50-55% of maximum heart rate for 1 minute ).
|
The participants received a high-intensity interval exercise program of walking or running on a treadmill for approximately 40 minutes.
The training included a 10-minute warm-up at low intensity.
High-intensity interval exercise at a ratio of 1:1 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternating with low intensity 50-55% of maximum heart rate for 1 minute).
|
|
Experimental: HIT 1:2
The participants received a high-intensity interval exercise program of walking or running on a treadmill for approximately 40 minutes.
The training included a 10-minute warm-up at low intensity.
High-intensity interval exercise at a ratio of 1:2 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternate with low intensity 50-55% of maximum heart rate for 2 minutes).
|
The participants received a high-intensity interval exercise program of walking or running on a treadmill for approximately 40 minutes.
The training included a 10-minute warm-up at low intensity.
High-intensity interval exercise at a ratio of 1:2 (high intensity for 1 minute at 85-90% of maximum heart rate, then alternate with low intensity 50-55% of maximum heart rate for 2 minutes).
|
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, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
|
Peak nasal inspiratory flow change
Time Frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
|
Nasal blood flow change
Time Frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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.
Nasal blood flow measurements were performed before immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after exercise for each exercise program.
|
Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
|
Pulmonary functions change
Time Frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
|
Respiratory muscle strength change
Time Frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional exhaled nitric oxide
Time Frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
Participants inhaled deeply for two to three seconds before exhaling slowly.
Normally, it took 10 seconds to exhale.
|
Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes
|
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
- Savoure M, Bousquet J, Jaakkola JJK, Jaakkola MS, Jacquemin B, Nadif R. Worldwide prevalence of rhinitis in adults: A review of definitions and temporal evolution. Clin Transl Allergy. 2022 Mar;12(3):e12130. doi: 10.1002/clt2.12130.
- Min YG. The pathophysiology, diagnosis and treatment of allergic rhinitis. Allergy Asthma Immunol Res. 2010 Apr;2(2):65-76. doi: 10.4168/aair.2010.2.2.65. Epub 2010 Mar 24.
- Kalpaklioglu AF, Kalkan IK. Comparison of orally exhaled nitric oxide in allergic versus nonallergic rhinitis. Am J Rhinol Allergy. 2012 Mar-Apr;26(2):e50-4. doi: 10.2500/ajra.2012.26.3717.
- 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.
- Dunham C, Harms CA. Effects of high-intensity interval training on pulmonary function. Eur J Appl Physiol. 2012 Aug;112(8):3061-8. doi: 10.1007/s00421-011-2285-5. Epub 2011 Dec 23.
- Andrade DC, Arce-Alvarez A, Parada F, Uribe S, Gordillo P, Dupre A, Ojeda C, Palumbo F, Castro G, Vasquez-Munoz M, Del Rio R, Ramirez-Campillo R, Izquierdo M. Acute effects of high-intensity interval training session and endurance exercise on pulmonary function and cardiorespiratory coupling. Physiol Rep. 2020 Aug;8(15):e14455. doi: 10.14814/phy2.14455.
- Gao M, Huang Y, Wang Q, Liu K, Sun G. Effects of High-Intensity Interval Training on Pulmonary Function and Exercise Capacity in Individuals with Chronic Obstructive Pulmonary Disease: A Meta-Analysis and Systematic Review. Adv Ther. 2022 Jan;39(1):94-116. doi: 10.1007/s12325-021-01920-6. Epub 2021 Nov 18. Erratum In: Adv Ther. 2022 Jul;39(7):3424.
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)
September 10, 2022
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
December 20, 2022
Study Registration Dates
First Submitted
March 9, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
March 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX PHYSIO SPSC 5
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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