NCT05779046

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 10, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

21 days

First QC Date

March 9, 2023

Last Update Submit

March 20, 2023

Conditions

Keywords

Allergic rhinitsAcute exerciseHigh intensity interval trainingRhinitis symptomsnasal blood flow

Outcome Measures

Primary Outcomes (5)

  • 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)

    Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes

  • 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.

    Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes

  • Nasal blood flow change

    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

    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

    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 Outcomes (1)

  • Fractional exhaled nitric oxide

    Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes

Study Arms (2)

HIT 1:1

EXPERIMENTAL

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 ).

Other: HIT 1:1

HIT 1:2

EXPERIMENTAL

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).

Other: HIT 1:2

Interventions

HIT 1:1OTHER

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).

HIT 1:1
HIT 1:2OTHER

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).

HIT 1:2

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 (7)

  • 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.

    PMID: 35344304BACKGROUND
  • 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
  • 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.

    PMID: 22487277BACKGROUND
  • 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.

    PMID: 23156847BACKGROUND
  • 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.

    PMID: 22194005BACKGROUND
  • 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.

    PMID: 32748551BACKGROUND
  • 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.

    PMID: 34792785BACKGROUND

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: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

September 10, 2022

Primary Completion

October 1, 2022

Study Completion

December 20, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations