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NCT Number: NCT02123914

The Effect of Exercises on Physiological Changes and Clinical Symptoms in Allergic Rhinitis Patients

1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis 2. Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis 3. Moderate exercise training combined with vitamin C supplementation has more beneficial effects than moderate exercise training alone for decreasing cytokine response and rhinitis symptoms in patients with allergic rhinitis

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The inclusion criteria included patients with allergic rhinitis who had a clinical history of persistent rhinitis, and had positive skin prick test (wheal diameter ≥ 3 mm) to house dust mite (D. pteronyssinus).

Exclusion criteria

Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.

Treatment and study plan

Aerobic exercise with Vit. C

Other

walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week combined with taking vitamin C supplemented daily with an oral dose of 2,000 mg 2 times/day for 8 weeks.

Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,

Nasal peak flow measurement,

Nasal blood flow measurement,

Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.

Aerobic Exercise

Other

walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week for 8 weeks.

Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,

Nasal peak flow measurement,

Nasal blood flow measurement,

Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.

No exercise

Other

Sedentary control.

Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,

Nasal peak flow measurement,

Nasal blood flow measurement,

Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.

Primary outcomes

  1. Changes from baseline in rhinitis symptoms

    Time frame: Baseline, week 8

    Nasal symptoms will be assessed using a rhinitis symptom score questionnaire. The subjects will be asked to score symptoms of persistent allergic rhinitis; nasal congestion, itching, sneezing, and rhinorrhea before and after each exercise protocol. The score ranged from 0 to 3 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).

  2. Changes from baseline in cytokine

    Time frame: baseline, week 8

    The cytokines IL-2, IL-4, and IL-13 in blood and nasal secretion will be determined by using the flow cytometry technique (Scavuzzo MC. et al., 2003). Data will be acquired using a flow cytometer (BD FACSCalibur Flow Cytometer, USA) and analyzed by FlowcytomixTM Pro software (eBioscience, USA.).

Secondary outcomes

  1. Changes from baseline in pulmonary function

    Time frame: Baseline, Week 8

    Pulmonary function (FVC and FEV1) will be conducted on all subjects using a calibrated computerized pneumotachograph spirometer (Spirotouch; Burdick, Inc., Deerfield, Wisconsin USA.) according to American Thoracic Society (ATS) recommendations (Laszlo G., 2006).

  2. Changes from baseline in cardiorespiratory fitness (VO2max)

    Time frame: Baseline, Week 8

    VO2max will be performed using bruce treadmill protocol. Subjects will be asked to run on a treadmill (Landice, USA) in which the grade and intensity will be increased every 3 minutes until exhaustion.

  3. Changes from baseline in nasal blood flow

    Time frame: Baseline, week 8

    Nasal mucosa blood flow will be measured by laser doppler flowmetry (DRT4 moor instrument, UK.). A side delivery endoscopic probe with flexible nylon sleeve with a diameter of 1.34 mm was placed on the anterior surface of the nose. The nasal blood flow values before and after exercise in each protocol will be then measured.

  4. Changes from baseline in peak nasal inspiratory flow

    Time frame: Baseline, Week 8

    Peak nasal inspiratory flow (PNIF) will be measured using a peak nasal inspiratory flow meter (Clement Clark International model IN-CHECK ORAL, UK.) attached to an anesthesia mask. During the procedure, the subjects placed a mask over the nose and mouth and inspired forcefully through the nose, with lips tightly closed. PNIF will be measured before and after exercise.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Effects of Chronic Exercise Training and Vitamin C Supplementation on Physiological Changes and Symptoms in Allergic Rhinitis Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Aug 4, 2015

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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