- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05870644
Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient
May 12, 2023 updated by: Wannaporn Tongtako, Ph.D., Chulalongkorn University
Acute Effects of Exercise at Different Temperatures on Nasal Blood Flow and Symptoms in Patient With Allergic Rhinitis.
The purpose of this study was to determine the effects of exercise at different temperatures on nasal blood flow and symptoms in allergic rhinitis patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Fifteen patients with allergic rhinitis aged between 18 and 35 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 aerobic exercise by ergometer in two difference temperatures room : 25 degree celsius and 34 degree celsius.
Rhinitis symptoms, nasal blood flow, heart rate, and oxygen saturation were measured before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
Moreover, blood pressure, peak nasal inspiratory flow, pulmonary functions, respiratory muscle strength, and fractional exhaled nitric oxide were measured before and after exercise at 0, 15 and 30 minutes in each temperature.
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
- Adult
Accepts Healthy Volunteers
No
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: Exercise in room temperature at 25 degree Celsius.
The participants received a moderate exercise program of cycling at moderate intensity (50-60% HRR) for 60 minutes in room temperature at 25 degree Celsius.
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The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 25 degree Celsius.
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|
Experimental: Exercise in room temperature at 34 degree Celsius.
The participants received a moderate exercise program of cycling at moderate intensity (50-60% HRR) for 60 minutes in room temperature at 34 degree Celsius.
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The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 34 degree Celsius.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rhinitis symptom scores change
Time Frame: Change among before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
|
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire.
The subjects were asked to score symptoms of persistent allergic rhinitis before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
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 among before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
|
|
Nasal blood flow change
Time Frame: Change among before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
|
Laser Doppler flowmetry (DRT4 moor instrument, UK.) was used to measure of the nasal blood flow (NBF).
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, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
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Change among before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature.
|
|
Peak nasal inspiratory flow change
Time Frame: Change before and after exercise at 0, 15 and 30 minutes in each temperature.
|
he 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.
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Change before and after exercise at 0, 15 and 30 minutes in each temperature.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional exhaled nitric oxide
Time Frame: Change before and after exercise at 0, 15 and 30 minutes in each temperature.
|
Participants inhaled deeply for two to three seconds before exhaling slowly.
Normally, it took 10 seconds to exhale.
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Change before and after exercise at 0, 15 and 30 minutes in each temperature.
|
|
Pulmonary functions change
Time Frame: Change before and after exercise at 0, 15 and 30 minutes in each temperature.
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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.
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Change before and after exercise at 0, 15 and 30 minutes in each temperature.
|
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Respiratory muscle strength change
Time Frame: Change before and after exercise at 0, 15 and 30 minutes in each temperature.
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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
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Change before and after exercise at 0, 15 and 30 minutes in each temperature.
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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
- Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldan Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.
- Bailey RS, Casey KP, Pawar SS, Garcia GJ. Correlation of Nasal Mucosal Temperature With Subjective Nasal Patency in Healthy Individuals. JAMA Facial Plast Surg. 2017 Jan 1;19(1):46-52. doi: 10.1001/jamafacial.2016.1445.
- 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.
- Katel P, Pinkaew B, Talek K, Tantilipikorn P. Pattern of Aeroallergen Sensitization and Quality of Life in Adult Thai Patients With Allergic Rhinitis. Front Allergy. 2021 Nov 15;2:695055. doi: 10.3389/falgy.2021.695055. eCollection 2021.
- Olsson P, Bende M. Influence of environmental temperature on human nasal mucosa. Ann Otol Rhinol Laryngol. 1985 Mar-Apr;94(2 Pt 1):153-5. doi: 10.1177/000348948509400211.
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, 2022
Primary Completion (Actual)
August 29, 2022
Study Completion (Actual)
January 23, 2023
Study Registration Dates
First Submitted
May 12, 2023
First Submitted That Met QC Criteria
May 12, 2023
First Posted (Actual)
May 23, 2023
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 12, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX PHYSIO SPSC 6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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