Allergic RhinitisNCT02123914
The Effect of Exercises on Physiological Changes and Clinical Symptoms in Allergic Rhinitis Patients
A study testing Aerobic exercise with Vit. C, Aerobic exercise and No exercise in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Aerobic exercise with Vit. C, Aerobic exercise and No exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Patumwan, Bangkok, 10330
About this study
Official title: Effects of Chronic Exercise Training and Vitamin C Supplementation on Physiological Changes and Symptoms in Allergic Rhinitis Patients
- Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
- Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
- 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
- Conditions
- Allergic Rhinitis
- Being tested
- Aerobic exercise with Vit. C, Aerobic exercise, No exercise
- Keywords
- Exercise training, Allergic rhinitis, Vitamin C, Cytokine, Rhinitis symptoms
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise with Vit. COther
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 exerciseOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise with Vit. C & Aerobic exercise | Experimental | Not described Receives: Other: Aerobic exercise with Vit. C; Other: Aerobic exercise |
| exercise without vit. c supplement & no exercise | Active comparator | Not described Receives: Other: Aerobic exercise with Vit. C; Other: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.).
Measured: baseline, week 8
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
- Investigators
- Daroonwan Suksom, Ph.D., Principal investigator, Faculty of Sports Science, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123914
- Sponsor's protocol ID
- SPSC-2
- Status last verified
- Aug 2015
- First submitted
- 22 Apr 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 14555860
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Exercise Training and Vitamin C Supplementation on Physiological Changes and Symptoms in Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT02123914
- Acronym / sponsor ID
- SPSC-2
- Conditions
- Allergic Rhinitis
- Keywords
- Exercise training, Allergic rhinitis, Vitamin C, Cytokine, Rhinitis symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
- Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise with Vit. C & Aerobic exercise | Experimental | Other: Aerobic exercise with Vit. C, Other: Aerobic exercise |
| exercise without vit. c supplement & no exercise | Active comparator | Other: Aerobic exercise with Vit. C, Other: No exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise with Vit. Cwalking - 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 with Vit. C & Aerobic exercise, exercise without vit. c supplement & no exercise |
| Aerobic exercisewalking - 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. | Other | Aerobic exercise with Vit. C & Aerobic exercise |
| No exerciseSedentary 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. | Other | exercise without vit. c supplement & no exercise |
Primary outcome
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).
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.).
4 secondary outcomes
Changes from baseline in pulmonary function
Time frame: Baseline, Week 8
Changes from baseline in cardiorespiratory fitness (VO2max)
Time frame: Baseline, Week 8
Changes from baseline in nasal blood flow
Time frame: Baseline, week 8
Changes from baseline in peak nasal inspiratory flow
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Background: PubMed 14555860Klaewsongkram 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daroonwan Suksom, Ph.D. principal investigator
Faculty of Sports Science, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise with Vit. C, Aerobic exercise and No exercise in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in rhinitis symptoms (time frame: Baseline, week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.