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Clinical Trials/NCT06543251
NCT06543251
Completed
Not Applicable

The Effects of Training Between High-Intensity Interval and Moderate Continuous Exercise on Respiratory Function and Rhinitis Symptoms in Patients With Allergic Rhinitis.

Chulalongkorn University1 site in 1 country36 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Allergic Rhinitis
Sponsor
Chulalongkorn University
Enrollment
36
Locations
1
Primary Endpoint
Rhinitis symptom scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

The objective of this study was to compare the effects of training between high-intensity interval training and moderate continuous exercise training on the pulmonary function, respiratory muscle strength, symptoms of patients with allergic rhinitis, cytokines, and oxidative stress in patients with allergic rhinitis.

Detailed Description

36 patients with allergic rhinitis were divided into 3 groups, 12 people per group: the control group (CON), the group with high-intensity interval training at a ratio of 1:2 (HIIT) and the group with moderate continuous training (MCT), 3 days per week, over a total period of 12 weeks. Before and after the experiment, lung function, respiratory muscle strength, allergic rhinitis symptoms, nasal blood flow rate, peak nasal inspiratory flow, nitric oxide levels, cytokines and quality of life were measured and used for statistical analysis.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
October 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wannaporn Tongtako, Ph.D.

Principal investigator

Chulalongkorn University

Eligibility Criteria

Inclusion Criteria

  • A patient with allergic rhinitis who underwent a skin prick test and received a positive result.
  • Patients with persistent allergic rhinitis, male and female, with symptoms of nasal congestion, sneezing, nasal itching, and runny nose for more than 4 days per week, and an average score of 7 or more in the past week using the allergic rhinitis symptom assessment questionnaire.
  • stopped taking all medicine before the study such as antihistamine for 3 days, oral steroid and nasal steroid for at least 2 weeks and leukotriene receptor antagonist for at least a week prior to the study
  • had no exercise program, non-smoking and without any food supplementation for at least 6 months prior to the start of the study
  • Must not have other respiratory diseases such as bronchitis, pertussis, pneumonia, pneumonitis, aspergilloma, tuberculosis, asthma, lung cancer, emphysema, etc.
  • Have a body mass index (BMI) between 18.5 and 24.9 kg/m².
  • Complete the Physical Activity Readiness Questionnaire (PAR-Q+) by answering "no" to all questions.

Exclusion Criteria

  • There is an unforeseen circumstance, such as an illness, that prevents participation in the research.
  • Less than 80% of the research was completed.

Outcomes

Primary Outcomes

Rhinitis symptom scores

Time Frame: Change from Baseline Rhinitis symptom scores at 12 weeks.

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)

Peak nasal inspiratory flow

Time Frame: Change from Baseline Peak nasal inspiratory flow scores at 12 weeks.

The subjects placed a mask, which is turned onto a plastic cylinder through which the air passes during inspiration, over the nose and mouth and inspired forcefully through the nose, with lips tightly closed. Inside the cylinder, there is a diaphragm that moves to the airflow, and the maximum peak flow is registered in a scale range from 30-370 L/min. During the procedure, the subjects placed a mask over the nose and mouth and inspired forcefully through the nose, with lips tightly closed.

Nasal blood flow

Time Frame: Change from Baseline Nasal blood flow scores at 12 weeks.

Laser Doppler flowmetry (DRT4 moor instrument, UK.) was used to measure of the nasal blood flow (NBF). Before the test each subject rested for one hour in a separate room. During the test, they were instructed to breathe normally breathe and not to speak, cough, or move. A lateral endoscopic probe with a flexible nylon sheath 1.34-mm-diameter flexible nylon sheath was placed to the front of the nose.

Pulmonary Functions

Time Frame: Change from Baseline Pulmonary Functions at 12 weeks.

The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration.

Respiratory muscle strength

Time Frame: Change from Baseline Respiratory muscle strength at 12 weeks.

Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity \[FRC\] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity \[TLC\] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds

Fraction exhaled nitric oxide

Time Frame: Change from Baseline Fraction exhaled nitric oxide at 12 weeks.

Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.

Aerobic capacity

Time Frame: Change from Baseline Aerobic capacity at 12 weeks.

Aerobic capacity variables were measured by determining maximum oxygen uptake (VO2max) using the Bruce protocol. The subjects ran on a treadmill. At the beginning of the test, the baseline or resting value was collected for the first 3 minutes. The initial speed was set at step 1 (minutes 0-3) at a speed of 1.7 mph with a 10% incline. The test was incremented every 3 minutes. Step 2 (minutes 4-6) was conducted at a speed of 2.5 mph with a 2% incline. The test continued until the subjects could not run any further. Following this, the subjects were cooled down for 3 minutes. The maximum oxygen uptake was measured in milliliters per kilogram per minute (ml/kg/min).

Secondary Outcomes

  • Rhinoconjunctivitis quality of life questionnaire - 36; Rcq-36(Change from Baseline quality of life at 12 weeks.)
  • Cytokine in nasal secretion(Change from Baseline Cytokine in nasal secretion at 12 weeks.)

Study Sites (1)

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