NCT05870644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

28 days

First QC Date

May 12, 2023

Last Update Submit

May 12, 2023

Conditions

Keywords

aerobic exerciseallergic rhinitisnasal blood flowpeak nasal inspiratory flowacute exercise

Outcome Measures

Primary Outcomes (3)

  • 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)

    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

    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.

    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

    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.

    Change before and after exercise at 0, 15 and 30 minutes in each temperature.

Secondary Outcomes (3)

  • Fractional exhaled nitric oxide

    Change before and after exercise at 0, 15 and 30 minutes in each temperature.

  • Pulmonary functions change

    Change before and after exercise at 0, 15 and 30 minutes in each temperature.

  • Respiratory muscle strength change

    Change before and after exercise at 0, 15 and 30 minutes in each temperature.

Study Arms (2)

Exercise in room temperature at 25 degree Celsius.

EXPERIMENTAL

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.

Other: Cycling exercise in room temperature at 25 degree Celsius.

Exercise in room temperature at 34 degree Celsius.

EXPERIMENTAL

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.

Other: Cycling exercise in room temperature at 34 degree Celsius.

Interventions

The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 25 degree Celsius.

Exercise in room temperature at 25 degree Celsius.

The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 34 degree Celsius.

Exercise in room temperature at 34 degree Celsius.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Accident that are unable to continue the research, such as accidental injury or illness, etc.
  • Participants did not voluntarily participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 28602936BACKGROUND
  • 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.

    PMID: 20358020BACKGROUND
  • 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.

    PMID: 35387043BACKGROUND
  • 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.

    PMID: 3994233BACKGROUND
  • 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.

    PMID: 27918749BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 23, 2023

Study Start

August 1, 2022

Primary Completion

August 29, 2022

Study Completion

January 23, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations