Pilates Training in Patients With Allergic Rhinitis

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT05693883

Collaborator

(none)

Enrollment

Location

Arms

18.4

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the effects of pilates training on symptoms in patients with allergic rhinitis.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: Pilates training	N/A

Detailed Description

Twenty allergic rhinitis patients aged 18 - 35 years were randomized into 2 groups: control group (CON; n=9) and pilates training group (PTG; n=11). Participants in CON group do their daily routine without receiving any training program, while those in PTG group completed receiving pilates training program three time a week for ten week-long (60 minutes/time). The physiological data, rhinitis symptoms, cytokines, pulmonary function, respiratory muscle strength were analyzed during the pre-test and post-tests. The dependent variables between pre-test and post-tests were analyzed by paired t-test. The rhinitis symptoms and cytokines variables between pre-test and post-test were analyzed by repeated measures ANOVA. In addition, an independent t-test was used to compare the variables between groups. Statistical significance was defined as p < .05.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Pilates Training on Symptoms in Patients With Allergic Rhinitis

Actual Study Start Date :

Feb 15, 2021

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilates training The participant completed receiving pilates training program three time a week for ten week-long (60 minutes/time)	Other: Pilates training Subject participating in 60-min sessions for 10 weeks and Each session consisted of a 10-min warm up (Breathing, Imprint & release, Hip release, Spine rotation, Hip rolls, Scapula isolation, Arm circle, Elevation & depression scapulae, Head nod, Cat stretch), Pilates program 40-min (Toe tap, Ad prep, Breast stroke preps, Heel squeeze prone, Side leg lift, Single leg extension, One leg circle, Shoulder bridge prep, Four point, kneeling, Spine twist, Hundred prep, Roll up prep, shoulder bridge prep2, Breast stroke, Swimming, Half roll back) and 10-min cool down (Spine stretch forward, Shell stretch, Side bending, Cat stretch, Roll down)
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: Pilates training

The participant completed receiving pilates training program three time a week for ten week-long (60 minutes/time)

Other: Pilates training

Subject participating in 60-min sessions for 10 weeks and Each session consisted of a 10-min warm up (Breathing, Imprint & release, Hip release, Spine rotation, Hip rolls, Scapula isolation, Arm circle, Elevation & depression scapulae, Head nod, Cat stretch), Pilates program 40-min (Toe tap, Ad prep, Breast stroke preps, Heel squeeze prone, Side leg lift, Single leg extension, One leg circle, Shoulder bridge prep, Four point, kneeling, Spine twist, Hundred prep, Roll up prep, shoulder bridge prep2, Breast stroke, Swimming, Half roll back) and 10-min cool down (Spine stretch forward, Shell stretch, Side bending, Cat stretch, Roll down)

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Rhinitis symptom scores [Change from Baseline Rhinitis symptom scores at 10 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)
Cytokine in nasal secretion [Change from Baseline cytokines scores at 10 weeks.]
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

Secondary Outcome Measures

Respiratory muscle strength change [Change from Baseline respiratory muscle strength at 10 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
Pulmonary Functions [Change from Baseline Pulmonary Functions at 10 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

the persistent allergic rhinitis who had rhinitis symptoms more than 4 days a week and positive skin prick test to house dust mite were recruited
stopped taking all medicine before the study sus 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