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Allergic RhinitisNCT05693883

Pilates Training in Patients With Allergic Rhinitis

A study testing Pilates training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
Pilates training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteThailand
Study dates
15 Feb 2021to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • had complications with allergic rhinitis, sinusitis, ear tube malfunctions, asthma, lung cancer, emphysema, lower back pain, tendinitis and arthritis

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Sports Science, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Pilates training
Keywords
Allergic rhinitis, Pilates, Cytokine, Pulmonary function, Rhinitis symptoms
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pilates trainingOther

    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)

Study groups in NCT05693883
Study groupRoleWhat they receive
Pilates trainingExperimentalThe participant completed receiving pilates training program three time a week for ten week-long (60 minutes/time)
Receives: Other: Pilates training
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change from Baseline Rhinitis symptom scores at 10 weeks.

  2. 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

    Measured: Change from Baseline cytokines scores at 10 weeks.

Secondary outcomes (2)

  1. 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

    Measured: Change from Baseline respiratory muscle strength at 10 weeks.

  2. 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.

    Measured: Change from Baseline Pulmonary Functions at 10 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start15 Feb 2021
  3. Primary completion25 Jun 2021
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05693883
Sponsor's protocol ID
Ex Physio SPSC 4
Status last verified
Jan 2023
First submitted
12 Jan 2023
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25410840

  • 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.

    PubMed 25603743

  • 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.

    PubMed 28602936

  • 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.

    PubMed 31421665

Questions about this trial

What is this clinical trial studying?

A study testing Pilates training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinitis symptom scores (time frame: Change from Baseline Rhinitis symptom scores at 10 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05693883, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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