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Allergic RhinitisNCT05779046

Acute Effect of High Intensity Interval Exercise in Patients With Allergic Rhinitis

A study testing HIT 1:1 and HIT 1:2 in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
HIT 1:1 and HIT 1:2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteThailand
Study dates
10 Sep 2022to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Sports Science, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
HIT 1:1, HIT 1:2
Keywords
Allergic rhinits, Acute exercise, High intensity interval training, Rhinitis symptoms, nasal blood flow
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 1:2Other

    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).

Study groups in NCT05779046
Study groupRoleWhat they receive
HIT 1:1ExperimentalThe 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 ).
Receives: Other: HIT 1:1
HIT 1:2ExperimentalThe 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).
Receives: Other: HIT 1:2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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

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

Secondary outcomes (1)
  1. Fractional exhaled nitric oxide

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start10 Sep 2022
  3. Primary completion1 Oct 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model 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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779046
Sponsor's protocol ID
EX PHYSIO SPSC 5
Status last verified
Mar 2023
First submitted
9 Mar 2023
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35344304
  • 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.

    PubMed 20358020
  • 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.

    PubMed 22487277
  • 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.

    PubMed 23156847
  • 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.

    PubMed 22194005
  • 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.

    PubMed 32748551
  • 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.

    PubMed 34792785

Questions about this trial

What is this clinical trial studying?

A study testing HIT 1:1 and HIT 1:2 in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinitis symptom scores change (time frame: Change after each exercise immediately, 15 minutes, 30 minutes, 45 minutes, and 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779046, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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