NCT06176586

Brief Summary

The aim of this study is to investigate the effectiveness of mat Pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in Psoriatic Arthritis (PsA) patients with axial involvement.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

December 7, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

December 7, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

Pilates ExerciseArthritisSpine Mobility

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Performance

    The Ankylosing Spondylitis Performance Index (ASPI) will be used. The ASPI consists of three physical performance tasks: (a) bending forward to pick up six pencils from the floor; (b) putting on socks (average of three repetitions); and (c) getting up from the floor (average of three repetitions). Time to complete a task will be recorded in seconds for each test.

    At baseline and 12 weeks later

Secondary Outcomes (7)

  • Change in Functional Status

    At baseline and 12 weeks later

  • Change in Trunk Muscle Endurance

    At baseline and 12 weeks later

  • Change in Spinal Mobility

    At baseline and 12 weeks later

  • Chance in Disease Activity

    At baseline and 12 weeks later

  • Change in Fatigue

    At baseline and 12 weeks later

  • +2 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

Progressive mat Pilates exercises will be administered to by a physiotherapist in addition to the routine medical treatment.

Other: Mat Pilates Exercises

Control Group

NO INTERVENTION

Patients in control group will not receive any exercise intervention. They will continue to their routine medical treatment.

Interventions

The intervention will consist of mat Pilates exercises performed twice a week over a duration of 12 weeks, as an adjunct to the routine medical treatment for the patients, under the guidance of a qualified physiotherapist. Each exercise session will last for approximately 60 minutes. The treatment protocol will encompass targeted mobility exercises for the thoracic and lumbar regions, along with strengthening exercises focusing on core activation. The exercise program will be progressed in every four weeks.

Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being classified as PsA according to CASPAR Classification Criteria
  • Being between the ages of 18-65
  • Volunteering to participate in the study

You may not qualify if:

  • Any additional systemic disease other than PsA
  • Any other condition that may prevent participation/continuation of the exercise program or completion of the assessments
  • Regular exercise habits (following a structured exercise program at least 3 days a week)
  • Being included in a physiotherapy and rehabilitation program within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (8)

  • Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.

    PMID: 23014338BACKGROUND
  • Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015 Nov;41(4):545-68. doi: 10.1016/j.rdc.2015.07.001. Epub 2015 Sep 11.

    PMID: 26476218BACKGROUND
  • Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.

    PMID: 15708927BACKGROUND
  • Chimenti MS, Triggianese P, Conigliaro P, Santoro M, Lucchetti R, Perricone R. Self-reported adherence to a home-based exercise program among patients affected by psoriatic arthritis with minimal disease activity. Drug Dev Res. 2014 Nov;75 Suppl 1:S57-9. doi: 10.1002/ddr.21197.

    PMID: 25381979BACKGROUND
  • 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
  • Caglayan BC, Keskin A, Gur Kabul E, Basakci Calik B, Bas Aslan U, Karasu U. Effects of clinical Pilates exercises in individuals with fibromyalgia: A randomized controlled trial. Eur J Rheumatol. 2021 Jul;8(3):150-155. doi: 10.5152/eurjrheum.2020.20037.

    PMID: 33372888BACKGROUND
  • 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: 36775528BACKGROUND
  • Oksuz S, Unal E. Comparison of the effects of aerobic training alone versus aerobic training combined with clinical Pilates exercises on the functional and psychosocial status of patients with ankylosing spondylitis: A randomized controlled trial. Physiother Theory Pract. 2023 Jan;39(1):61-71. doi: 10.1080/09593985.2021.2005199. Epub 2021 Nov 18.

    PMID: 34791973BACKGROUND

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Deniz Bayraktar, PhD

    Izmir Katip Celebi 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
Assistant Professor

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 19, 2023

Study Start

January 8, 2024

Primary Completion

March 11, 2024

Study Completion

June 10, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Data may only be provided upon a reasonable request for academic research purposes.

Locations