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

Effects of Chronic Exercise Training and Vitamin C Supplementation on Physiological Changes and 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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other: Aerobic exercise with Vit. C; Other: Aerobic exercise; Other: No exercise

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Patumwan, Bangkok, Thailand, 10330
      • Faculty of Sports Science, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise with Vit. C & Aerobic exercise	Other: Aerobic exercise with Vit. C; 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.; Other: Aerobic exercise; 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.
Active Comparator: exercise without vit. c supplement & no exercise	Other: Aerobic exercise with Vit. C; 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.; Other: No exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in rhinitis symptoms	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).	Baseline, week 8
Changes from baseline in cytokine	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.).	baseline, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in pulmonary function	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).	Baseline, Week 8
Changes from baseline in cardiorespiratory fitness (VO2max)	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.	Baseline, Week 8
Changes from baseline in nasal blood flow	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.	Baseline, week 8
Changes from baseline in peak nasal inspiratory flow	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.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Daroonwan Suksom, Ph.D., Faculty of Sports Science, Chulalongkorn University

Publications and helpful links

General Publications

• Klaewsongkram J, Ruxrungtham K, Wannakrairot P, Ruangvejvorachai P, Phanupak P. Eosinophil count in nasal mucosa is more suitable than the number of ICAM-1-positive nasal epithelial cells to evaluate the severity of house dust mite-sensitive allergic rhinitis: a clinical correlation study. Int Arch Allergy Immunol. 2003 Sep;132(1):68-75. doi: 10.1159/000073266.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: August 1, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Exercise training; Cytokine; Vitamin C; Allergic rhinitis; Rhinitis symptoms
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: SPSC-2