Mat Pilates Exercise Program in Patients With Axial Psoriatic Arthritis

April 8, 2024 updated by: Deniz Bayraktar, Izmir Katip Celebi University

Investigating the Effects of Mat Pilates Exercises in Patients With Axial Psoriatic Arthritis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Psoriasis is a chronic inflammatory skin disease commonly accompanied by joint involvement known as psoriatic arthritis (PsA) [1]. PsA is a subgroup of spondyloarthritis and is characterized by peripheral arthritis, dactylitis, enthesitis and spondylitis. Axial involvement, which occurs in approximately 40% of PsA patients may affect the entire spine, particularly the sacroiliac joint, leading to reduced cervical rotation, lateral flexion and anterior flexion of the spine [2,3]. Exercise interventions in PsA primarily aim to relieve pain, improve mobility and enhance functional capacity [4]. Mat Pilates exercises have been demonstrated as a safe and beneficial intervention in various rheumatic diseases, exhibiting significant improvements in functional status, fatigue, disease activity, pain, and overall quality of life [5-7]. Additionally, Pilates has been reported as effective in maintaining and enhancing spinal mobility [8,9]. However, despite these favorable outcomes, the efficacy of Pilates exercises in PsA remains unexplored.

The aim of this study is to investigate the effectiveness of mat pilates exercises in psoriatic arthritis patients with axial involvement.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • İzmir Katip Çelebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
Progressive mat Pilates exercises will be administered to by a physiotherapist in addition to the routine medical treatment.
Other: Mat Pilates Exercises
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.
No Intervention: Control Group
Patients in control group will not receive any exercise intervention. They will continue to their routine medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Performance
Time Frame: At baseline and 12 weeks later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Status
Time Frame: At baseline and 12 weeks later
Bath Ankylosing Spondylitis Functional Index (BASFI) will be used. This self-reported scale evaluates the degree of functional limitation of patients in activities of daily living. It consists of 10 questions scored between 0-10 (0: easy, 10: impossible). The higher total scores indicate more functional limitation.
At baseline and 12 weeks later
Change in Trunk Muscle Endurance
Time Frame: At baseline and 12 weeks later
A static endurance test (lateral bridge test) will be employed to evaluate trunk muscle endurance. During this assessment, patients will be positioned in side-lying. Participants will be required to maintain this lateral bridge position for as long as possible, and the duration until the position cannot be maintained will be recorded in seconds.
At baseline and 12 weeks later
Change in Spinal Mobility
Time Frame: At baseline and 12 weeks later
Spinal mobility will be assessed by using the Bath Ankylosing Spondylitis Mobility Index including cervical rotation, modified Schober test (anterior flexion of the spine), maximal intermalleolar distance, lateral flexion of the spine, and tragus-wall distance. Higher scores indicate more limited spinal mobility.
At baseline and 12 weeks later
Chance in Disease Activity
Time Frame: At baseline and 12 weeks later
The Disease Activity Index for Psoriatic Arthritis (DAPSA) will be used for evaluating the disease activity. DAPSA is a composite score including the number of tender joints (over 68 joints), the number of swollen joints (over 68 joints), C-Reactive protein (CRP) level, the patient's self-reported health status, and evaluation of the patient's health status by the physician. DAPSA is calculated by summing all the values, and higher scores indicate higher disease activity.
At baseline and 12 weeks later
Change in Fatigue
Time Frame: At baseline and 12 weeks later
The Fatigue Severity Scale (FSS) will be used to evaluate the fatigue. It comprises 9 items that assess the severity of fatigue symptoms experienced by participants over the previous week. Each question is scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), and the scores are then averaged to derive the total score. Higher scores indicate more fatigue.
At baseline and 12 weeks later
Change in Emotional Status
Time Frame: At baseline and 12 weeks later
The Hospital Anxiety and Depression Scale (HADS) will be used to evaluate emotional status. The HADS includes two sections: depression (7 questions) and anxiety (7 questions). Each question is scored between 0 and 3. Higher scores indicate higher anxiety or depression levels.
At baseline and 12 weeks later
Change in Quality of Life
Time Frame: At baseline and 12 weeks later
The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire will be used to assess the disease-related changes in quality of life. The PsAQoL includes 20 questions, each answered with either yes (1 point) or no (0 point). Higher scores indicate a reduced quality of life.
At baseline and 12 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Principal Investigator: Deniz Bayraktar, PhD, İzmir Katip Çelebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

March 11, 2024

Study Completion (Estimated)

June 10, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSApilex

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Mat Pilates Exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe