NCT05693883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 12, 2023

Last Update Submit

January 12, 2023

Conditions

Keywords

Allergic rhinitisPilatesCytokinePulmonary functionRhinitis symptoms

Outcome Measures

Primary Outcomes (2)

  • 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 10 weeks.

  • 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

    Change from Baseline cytokines scores at 10 weeks.

Secondary Outcomes (2)

  • Respiratory muscle strength change

    Change from Baseline respiratory muscle strength at 10 weeks.

  • Pulmonary Functions

    Change from Baseline Pulmonary Functions at 10 weeks.

Study Arms (2)

Pilates training

EXPERIMENTAL

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

Other: Pilates training

Control group

NO INTERVENTION

Interventions

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)

Pilates training

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 25410840BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

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

January 12, 2023

First Posted

January 23, 2023

Study Start

February 15, 2021

Primary Completion

June 25, 2021

Study Completion

August 30, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations