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Completed

NCT Number: NCT05870644

Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycling exercise in room temperature at 25 degree Celsius.

Other

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

Cycling exercise in room temperature at 34 degree Celsius.

Other

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. Pulmonary functions change

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

    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.

  3. Respiratory muscle strength change

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

    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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Acute Effects of Exercise at Different Temperatures on Nasal Blood Flow and Symptoms in Patient With Allergic Rhinitis.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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