NCT03904953

Brief Summary

Background: Ankylosing Spondylitis (AS) is a chronic, inflammatory rheumatic disease that effects primarily axial-spine. Reduction of flexibility and mobility is important factors that can cause muscle weakness, impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. The purpose of this study is to investigate the effects of pilates exercises on mobility, quality of life and respiratory muscle strength in patients with AS. Methods: Forty patients will be included who are aged between 18-55 years and got diagnosed according to Modified New York criterias.Patients will be divided into two groups randomly. Pilates training will be performed to the treatment group and conventional exercises will be performed to the control group during 8 weeks. Respiratory muscle strength, quality of life, spinal mobility, thorax expansion, respiratory functions, physical activity level, exercise capasity and disease activity will be evaluated at first session and at the end of the 8th week in this study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 2, 2019

Last Update Submit

April 5, 2019

Conditions

Keywords

Ankylosing SpondylitisPilatesRespiratory muscle strenght

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

    Respiratory muscle strength will be assessed by digital mouth-pressure meter (Micro Medical MicroRM, Rochester, England). Maksimal inspiratory pressure (MIP) and Maksimal Expiratory Pressure (MEP) will be measured with the subject sitting and breathing through a mouthpiece by encouraged verbally, after clamping the nose (cmH2O). To measure MIP, the patient will be requested to breath in quickly and deeply until total lung capacity, just after breath out maximally until residual volume. To measure MEP, the patient will be requested to breath until total lung capacity and then breath out quickly until residual volume. Leaks around the mouthpiece will be avoided. The best of five attempts will be selected and stated as percent of expected values according to sex and age

    5 minutes

Secondary Outcomes (7)

  • Bath Ankylosing Spondylitis Metrology Index

    5 minutes

  • Ankylosing Spondylitis Quality of Life Questionnaire

    1 minute

  • Thorax pain

    1 minute

  • Chest expansion

    2 minutes

  • Aerobic capacity

    10 minutes

  • +2 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: Pilates Training

Control group

ACTIVE COMPARATOR

Stretching of erector spine, hip flexors, hamstring muscles and gastro-soleus muscles; back-strengthening of cervical, thoracic and lumbar spine and posture exercises will be taught to the patients in the first session and the patients will be requested to repeat the exercises three times a week for 8 weeks individually at home.

Other: Conventional exercise programme

Interventions

Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Study group

Stretching of erector spine, hip flexors, hamstring muscles and gastro-soleus muscles; back-strengthening of cervical, thoracic and lumbar spine and posture exercises will be taught to the patients in the first session and the patients will be requested to repeat the exercises three times a week for 8 weeks individually at home.

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are aged between 18-55 years,
  • Patients who got diagnosed according to Modified New York criteria
  • Patients who are being followed at Gazi University Department of Rheumatology.

You may not qualify if:

  • Patients who have exercise habits
  • Incooperation
  • Malignancy
  • Pregnancy
  • Patients who have changes of medical treatment in the last 3 months
  • Patients who have another disease that can effect pulmonary functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Altan L, Korkmaz N, Dizdar M, Yurtkuran M. Effect of Pilates training on people with ankylosing spondylitis. Rheumatol Int. 2012 Jul;32(7):2093-9. doi: 10.1007/s00296-011-1932-9. Epub 2011 Apr 17.

    PMID: 21499876BACKGROUND
  • Rosu MO, Topa I, Chirieac R, Ancuta C. Effects of Pilates, McKenzie and Heckscher training on disease activity, spinal motility and pulmonary function in patients with ankylosing spondylitis: a randomized controlled trial. Rheumatol Int. 2014 Mar;34(3):367-72. doi: 10.1007/s00296-013-2869-y. Epub 2013 Sep 26.

    PMID: 24071935BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Deran Oskay

    Gazi University Faculty of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

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
Research Assistant

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 5, 2019

Study Start

April 2, 2019

Primary Completion

June 2, 2019

Study Completion

October 2, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations