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Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Cycling exercise in room temperature at 25 degree Celsius.
Cycling exercise in room temperature at 34 degree Celsius.
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring aerobic exercise, allergic rhinitis, nasal blood flow, peak nasal inspiratory flow, acute exercise

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Sports Science, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise in room temperature at 25 degree Celsius.

Exercise in room temperature at 34 degree Celsius.

Arm Description

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.

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.

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, 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)
Nasal blood flow change
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.
Peak nasal inspiratory flow change
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.

Secondary Outcome Measures

Fractional exhaled nitric oxide
Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.
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

Full Information

First Posted
May 12, 2023
Last Updated
May 12, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05870644
Brief Title
Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient
Official Title
Acute Effects of Exercise at Different Temperatures on Nasal Blood Flow and Symptoms in Patient With Allergic Rhinitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
January 23, 2023 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
aerobic exercise, allergic rhinitis, nasal blood flow, peak nasal inspiratory flow, acute exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise in room temperature at 25 degree Celsius.
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise in room temperature at 34 degree Celsius.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cycling exercise in room temperature at 25 degree Celsius.
Intervention Description
The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 25 degree Celsius.
Intervention Type
Other
Intervention Name(s)
Cycling exercise in room temperature at 34 degree Celsius.
Intervention Description
The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 34 degree Celsius.
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, 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)
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.
Title
Nasal blood flow change
Description
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.
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.
Title
Peak nasal inspiratory flow change
Description
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.
Time Frame
Change before and after exercise at 0, 15 and 30 minutes in each temperature.
Secondary Outcome Measure Information:
Title
Fractional exhaled nitric oxide
Description
Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.
Time Frame
Change before and after exercise at 0, 15 and 30 minutes in each temperature.
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 before and after exercise at 0, 15 and 30 minutes in each temperature.
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 before and after exercise at 0, 15 and 30 minutes in each temperature.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28602936
Citation
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.
Results Reference
background
PubMed Identifier
20358020
Citation
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.
Results Reference
background
PubMed Identifier
35387043
Citation
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.
Results Reference
background
PubMed Identifier
3994233
Citation
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.
Results Reference
background
PubMed Identifier
27918749
Citation
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.
Results Reference
background

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Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient

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