NCT05707611

Brief Summary

This study was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

January 12, 2023

Last Update Submit

April 2, 2023

Conditions

Keywords

Allergic rhinitsCytokinesAerobic exerciseRhinitis symptoms

Outcome Measures

Primary Outcomes (2)

  • Rhinitis symptom scores change

    Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)

    Change after each exercise immediately

  • Cytokine in nasal secretion change

    Nasal secretions collection was performed bilaterally with filter paper strips (7x30 mm Whatman No.42, Whatman, Clifton, NJ). Three filter paper strips were sequentially placed on each anterior portion of the inferior turbinate for 10 min. This filter paper strips were collected into appropriate tubes and centrifuged at 3,000 rpm for 5 min at 4 °C and immediately frozen at -70 °C until later analysis.The levels of cytokines were determined by using Sandwich ELISA technique

    Change after each exercise immediately

Secondary Outcomes (3)

  • Pulmonary functions change

    Change after each exercise immediately

  • Respiratory muscle strength change

    Change after each exercise immediately

  • Peak nasal inspiratory flow change

    Change after each exercise immediately

Study Arms (3)

Running

EXPERIMENTAL

Running on treadmill in moderate intensity for 30 minutes

Other: Running

Cycling

EXPERIMENTAL

Cycling on ergometer in moderate intensity for 30 minutes

Other: Cycling

Swimming

EXPERIMENTAL

Swimming in moderate in tensity for 30 minutes

Other: Swimming

Interventions

RunningOTHER

The participant perform running on treadmill at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.

Running
CyclingOTHER

The participant perform cycling on cycle ergometer at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.

Cycling

The participant perform swimming at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.

Swimming

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of allergic rhinitis diseases
  • Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
  • Positive skin prick test (wheal diameter\>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
  • Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.

You may not qualify if:

  • Asthma, Chronic rhino-sinusitis, Hypertension, Cardiovascular diseases
  • A smoking habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (3)

  • Aldred S, Love JA, Tonks LA, Stephens E, Jones DS, Blannin AK. The effect of steady state exercise on circulating human IgE and IgG in young healthy volunteers with known allergy. J Sci Med Sport. 2010 Jan;13(1):16-9. doi: 10.1016/j.jsams.2008.07.001. Epub 2008 Oct 31.

  • Tongtako W, Klaewsongkram J, Jaronsukwimal N, Buranapraditkun S, Mickleborough TD, Suksom D. The effect of acute exhaustive and moderate intensity exercises on nasal cytokine secretion and clinical symptoms in allergic rhinitis patients. Asian Pac J Allergy Immunol. 2012 Sep;30(3):185-92.

  • Park J, Park JH, Park J, Choi J, Kim TH. Association between Allergic Rhinitis and Regular Physical Activity in Adults: A Nationwide Cross-Sectional Study. Int J Environ Res Public Health. 2020 Aug 5;17(16):5662. doi: 10.3390/ijerph17165662.

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

RunningSwimming

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p \< 0.05.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 1, 2023

Study Start

August 1, 2020

Primary Completion

October 15, 2022

Study Completion

December 20, 2022

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations