NCT02123914

Brief Summary

  1. 1.Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
  2. 2.Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
  3. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

April 22, 2014

Last Update Submit

August 1, 2015

Conditions

Keywords

Exercise trainingAllergic rhinitisVitamin CCytokineRhinitis symptoms

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

EXPERIMENTAL
Other: Aerobic exercise with Vit. COther: Aerobic exercise

exercise without vit. c supplement & no exercise

ACTIVE COMPARATOR
Other: Aerobic exercise with Vit. COther: No exercise

Interventions

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 with Vit. C & Aerobic exerciseexercise without vit. c supplement & no 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.

Aerobic exercise with Vit. C & Aerobic 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.

exercise without vit. c supplement & no exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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

Rhinitis, Allergic

Interventions

ExerciseAscorbic Acid

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Daroonwan Suksom, Ph.D.

    Faculty of Sports Science, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

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

Locations