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Pilates Training in Patients With Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pilates training
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Pilates, Cytokine, Pulmonary function, Rhinitis symptoms

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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 Exclusion Criteria: had complications with allergic rhinitis, sinusitis, ear tube malfunctions, asthma, lung cancer, emphysema, lower back pain, tendinitis and arthritis

Sites / Locations

  • Faculty of Sports Science, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pilates training

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Cytokine in nasal secretion
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
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
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.

Full Information

First Posted
January 12, 2023
Last Updated
January 12, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05693883
Brief Title
Pilates Training in Patients With Allergic Rhinitis
Official Title
The Effects of Pilates Training on Symptoms in Patients With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic rhinitis, Pilates, Cytokine, Pulmonary function, Rhinitis symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates training
Arm Type
Experimental
Arm Description
The participant completed receiving pilates training program three time a week for ten week-long (60 minutes/time)
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pilates training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rhinitis symptom scores
Description
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)
Time Frame
Change from Baseline Rhinitis symptom scores at 10 weeks.
Title
Cytokine in nasal secretion
Description
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
Time Frame
Change from Baseline cytokines scores at 10 weeks.
Secondary Outcome Measure Information:
Title
Respiratory muscle strength change
Description
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
Time Frame
Change from Baseline respiratory muscle strength at 10 weeks.
Title
Pulmonary Functions
Description
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.
Time Frame
Change from Baseline Pulmonary Functions at 10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: had complications with allergic rhinitis, sinusitis, ear tube malfunctions, asthma, lung cancer, emphysema, lower back pain, tendinitis and arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wannaporn Tongtako, Ph.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25410840
Citation
Franco CB, Ribeiro AF, Morcillo AM, Zambon MP, Almeida MB, Rozov T. Air stacking: effects of Pilates mat exercises on muscle strength and on pulmonary function in patients with cystic fibrosis. J Bras Pneumol. 2014 Oct;40(5):521-7. doi: 10.1590/s1806-37132014000500008.
Results Reference
background
PubMed Identifier
25603743
Citation
Barbosa AW, Guedes CA, Bonifacio DN, de Fatima Silva A, Martins FL, Almeida Barbosa MC. The Pilates breathing technique increases the electromyographic amplitude level of the deep abdominal muscles in untrained people. J Bodyw Mov Ther. 2015 Jan;19(1):57-61. doi: 10.1016/j.jbmt.2014.05.011. Epub 2014 Jun 5.
Results Reference
result
PubMed Identifier
28602936
Citation
Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldan Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.
Results Reference
result
PubMed Identifier
31421665
Citation
Chanta A, Klaewsongkram J, Mickleborough TD, Tongtako W. Effect of Hatha yoga training on rhinitis symptoms and cytokines in allergic rhinitis patients. Asian Pac J Allergy Immunol. 2022 Jun;40(2):126-133. doi: 10.12932/AP-260419-0547.
Results Reference
result

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Pilates Training in Patients With Allergic Rhinitis

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