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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123914
• Other study ID #: SPSC-2
• Status: Completed
• Phase: N/A
• First received: April 22, 2014
• Last updated: August 1, 2015
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes