- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693883
Pilates Training in Patients With Allergic Rhinitis
January 12, 2023 updated by: Wannaporn Tongtako, Ph.D., Chulalongkorn University
The Effects of Pilates Training on Symptoms in Patients With Allergic Rhinitis
The purpose of this study was to determine the effects of pilates training on symptoms in patients with allergic rhinitis.
Study Overview
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Pathum Wan, Bangkok, Thailand, 10330
- Faculty of Sports Science, Chulalongkorn University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Pilates training
The participant completed receiving pilates training program three time a week for ten week-long (60 minutes/time)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rhinitis symptom scores
Time Frame: 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)
|
Change from Baseline Rhinitis symptom scores at 10 weeks.
|
|
Cytokine in nasal secretion
Time Frame: 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
|
Change from Baseline cytokines scores at 10 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory muscle strength change
Time Frame: 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
|
Change from Baseline respiratory muscle strength at 10 weeks.
|
|
Pulmonary Functions
Time Frame: 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.
|
Change from Baseline Pulmonary Functions at 10 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wannaporn Tongtako, Ph.D., Chulalongkorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2021
Primary Completion (Actual)
June 25, 2021
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
January 12, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ex Physio SPSC 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Inimmune CorporationRho, Inc.CompletedAllergic Rhinitis | Rhinitis Allergic | Allergic Rhinitis Due to AllergensCanada
-
Polyrizon Ltd.Not yet recruitingAllergic Rhinitis | Seasonal Allergic Rhinitis (SAR)
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Kazakh National Agrarian UniversityNot yet recruitingRhinitis AllergicKazakhstan
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Shanghai Chia Tai Tianqing Pharmaceutical Technology...RecruitingSeasonal Allergic RhinitisChina
Clinical Trials on Pilates training
-
Universidade Federal de Santa MariaCompleted
-
Aydin Adnan Menderes UniversityCompleted
-
Universidade Federal do vale do São FranciscoCompletedBlood Pressure | Physical Disability | Type-2 Diabetes
-
Riphah International UniversityCompletedPost Partum DepressionPakistan
-
Cairo UniversityRecruiting
-
Universidade Norte do ParanáCompletedLow Back Pain | Exercise Training | Photobiomodulation TherapyBrazil
-
Necmettin Erbakan UniversityRecruitingExercise | Sedentary Behavior | Exercise Therapy | Awareness | Woman's RoleTurkey (Türkiye)
-
Riphah International UniversityCompletedMechanical Low Back PainPakistan
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted