NCT06543251

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 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

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 4, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

Allergic rhinitisAerobic exerciseHigh intensity interval trainingpulmonary functioncytokines

Outcome Measures

Primary Outcomes (7)

  • Rhinitis symptom scores

    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 from Baseline Rhinitis symptom scores at 12 weeks.

  • Peak nasal inspiratory flow

    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.

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

  • Nasal blood flow

    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.

    Change from Baseline Nasal blood flow scores at 12 weeks.

  • Pulmonary Functions

    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.

    Change from Baseline Pulmonary Functions at 12 weeks.

  • Respiratory muscle strength

    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

    Change from Baseline Respiratory muscle strength at 12 weeks.

  • Fraction exhaled nitric oxide

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

    Change from Baseline Fraction exhaled nitric oxide at 12 weeks.

  • Aerobic capacity

    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).

    Change from Baseline Aerobic capacity at 12 weeks.

Secondary Outcomes (2)

  • Cytokine in nasal secretion

    Change from Baseline Cytokine in nasal secretion at 12 weeks.

  • Rhinoconjunctivitis quality of life questionnaire - 36; Rcq-36

    Change from Baseline quality of life at 12 weeks.

Study Arms (3)

High-intensity interval training group (HIIT)

EXPERIMENTAL

the group with high-intensity interval training at a ratio of 1:2 (HIIT) 3 days per week, over a total period of 12 weeks.

Other: High-intensity interval training group (HIIT)

Moderate continuous training group (MCT)

EXPERIMENTAL

the group with moderate continuous training, 3 days per week, over a total period of 12 weeks.

Other: Moderate continuous training group (MCT)

Sedentary control group (CON)

OTHER
Other: Sedentary control group (CON)

Interventions

The participants performed HIIT programs for 12 weeks involving walking/running on a treadmill preceded by a 10-min warm-up at low intensity and exercise with high intensity for 1 min at 85%-90% of the maximum heart rate alternating with low intensity at 50%-55% of the maximum heart rate for 2 min, for 24 minutes, and 10-min cool down.

High-intensity interval training group (HIIT)

Subject participating in 30-min sessions for 12 weeks and Each session consisted of a 10-min warm up, walking/running on a treadmill 30 minutes at 65-70% Maximum Heart rate and 10-min cool down.

Moderate continuous training group (MCT)

The control group had normal daily life.

Sedentary control group (CON)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wannaporn Tongtako, Ph.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 7, 2024

Study Start

June 1, 2023

Primary Completion

September 25, 2023

Study Completion

October 15, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations