NCT04292028

Brief Summary

The objective of this study was to examine the effects of 8-week clinical Pilates training on disease-specific indices, core stability, and balance in ankylosing spondylitis (AS) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 25, 2020

Last Update Submit

March 2, 2020

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitispilatespostural balancephysical enduranceflexibility

Outcome Measures

Primary Outcomes (4)

  • Bath Ankylosing Sponsylitis Disease Activity Index (BASDAI)

    Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It gives a score ranging from 0-10. High score indicates an increase in disease activity.

    2 minutes

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    Functional status was assessed with BASFI. BASFI is comprised of ten items, eight questioning the activities of daily living and two the patient's ability to cope with everyday life. Each is answered on a 10-cm horizontal visual analogue scale (VAS). Total score ranges between 0 and 10, higher scores indicating more severe impairment.

    4 minutes

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    The Bath Ankylosing Spondylitis Metrology Index (BASMI) was used to assess spinal mobility. BASMI consists of clinical measures of cervical rotation, tragus wall distance, lumbal flexion (modified Schober) and intermalleolar distance.

    7 minutes

  • Ankylosing Spondylitis Quality of Life (ASQoL)

    Quality of life was assessed with the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, which is the most frequently used disease-specific measure of health-related quality of life. High scores in this 18-item questionnaire indicate severe impairment in quality of life.

    3 minutes

Secondary Outcomes (5)

  • Trunk flexor endurance test

    5 minutes

  • Trunk extensor endurance test

    5 minutes

  • Side bridge test

    5 minutes

  • Sit-up test

    2 minutes

  • Balance Assessment

    10 minutes

Study Arms (2)

pilates group

EXPERIMENTAL

The Pilates group participated in an 8-week clinical Pilates training program

Other: Pilates

Control group

ACTIVE COMPARATOR

Control group were given a home-based exercise program

Other: Home exercises

Interventions

PilatesOTHER

The Pilates group participated in an 8-week clinical Pilates training program

pilates group
Home exercisesOTHER

Control group were given a home-based exercise program.

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having AS diagnosis based on modified New York criteria,
  • being 20-60 years of age, volunteering to participate in the study,
  • having no regular exercise habit in the last 6 months,
  • agreeing not to participate in any other type of physical exercise program during the study

You may not qualify if:

  • not attending 4 consecutive Pilates or home exercise sessions,
  • change in medication within the previous 6 months or during the study,
  • presence of neurological or coexistent systemic disease, history of orthopedic surgery, and active enthesitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Eyalet/Yerleşke, 35320, Turkey (Türkiye)

Location

Related Publications (1)

  • Acar Y, Ilcin N, Gurpinar B, Can G. The effects of clinical pilates training on disease-specific indices, core stability, and balance in patients with ankylosing spondylitis. J Bodyw Mov Ther. 2023 Jan;33:69-75. doi: 10.1016/j.jbmt.2022.09.010. Epub 2022 Sep 23.

    PMID: 36775528DERIVED

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

  • NURSEN İLÇİN

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 2, 2020

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations

TU(1)