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 other identifier
interventional
27
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 4, 2015
August 1, 2015
2.6 years
April 22, 2014
August 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Changes from baseline in pulmonary function
Baseline, Week 8
Changes from baseline in cardiorespiratory fitness (VO2max)
Baseline, Week 8
Changes from baseline in nasal blood flow
Baseline, week 8
Changes from baseline in peak nasal inspiratory flow
Baseline, Week 8
Study Arms (2)
Aerobic exercise with Vit. C & Aerobic exercise
EXPERIMENTALexercise without vit. c supplement & no exercise
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may not qualify if:
- Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Sports Science, Chulalongkorn University
Patumwan, Bangkok, 10330, Thailand
Related 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. doi: 10.1159/000073266.
PMID: 14555860BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daroonwan Suksom, Ph.D.
Faculty of Sports Science, Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Sports Science
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 28, 2014
Study Start
January 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 4, 2015
Record last verified: 2015-08