The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women With Systemic Lupus Erythematosus

February 3, 2026 updated by: Emir İbrahim IŞIK

Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease with the potential to affect any organ in the body. The most frequently affected anatomical regions include the skin, joints, pleura, pericardium, kidneys and the central nervous system.

All systemic conditions observed in SLE cause functional deficiencies in daily life, fatigue, anxiety and depression, pain, sleep quality disorders, cognitive effects, cosmetic problems, social isolation, and all these characteristics negatively affect the quality of life of an individual with SLE.

The aim of this study is to investigate the effects of clinical pilates exercises on pain, fatigue, functional capacity, flexibility, emotional state, sleep and quality of life in patients with SLE.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women with Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease with the potential to affect any organ in the body. The most frequently affected anatomical regions include the skin, joints, pleura, pericardium, kidneys and the central nervous system.

All systemic conditions observed in SLE cause functional deficiencies in daily life, fatigue, anxiety and depression, pain, sleep quality disorders, cognitive effects, cosmetic problems, social isolation, and all these characteristics negatively affect the quality of life of an individual with SLE.

The aim of this study is to investigate the effects of clinical pilates exercises on pain, fatigue, functional capacity, flexibility, emotional state, sleep and quality of life in patients with SLE.

The objectives of this study are as follows:

  1. To examine the effect of a home exercise program on physical and psychological parameters in patients with SLE.
  2. To examine the effect of Pilates exercises to be performed under supervision added to the home exercise program on physical and psychological parameters in patients with SLE.
  3. To evaluate the cost-effectiveness of a home exercise program and clinical Pilates exercises.

MATERIAL AND METHOD Criteria for inclusion in the study: being a woman between the 18 Years to 65 Years , meeting the American College of Rheumatology SLE diagnostic criteria, having low disease activity (SLEDAI ≤4), agreeing to participate in the study Exclusion criteria from the study: presence of malignancy, pregnancy, change of treatment within the last 3 months, use of steroids equivalent to >16 mg prednisolone for the last 3 months, have other rheumatic diseases, have a regular exercise habit (physical activity more than two times a week), have a disease that restricts physical activity (such as neurological disorder, orthopedic disorder, cognitive disorder, immobility), have serious heart, lung or kidney involvement, uncontrolled hypertension, severe anemia (hb <8 g/dL), having undergone orthopedic surgery in the last 6 months.

Following the provision of informed consent, participants will be randomly divided into two groups using a computer program. In addition to the home exercise program, which is to be followed for a period of eight weeks, the intervention group will participate in supervised clinical Pilates exercises. These exercises will be administered in the form of group sessions, which are to be held twice per week. The control group will be provided with a home exercise program. This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.

Participants will be contacted by phone weekly to encourage compliance with the exercise regimen. In addition, participants will be given an exercise diary and instructed to record their exercise days in a systematic way. Participants who show less than 80% compliance with the exercise program during subsequent follow-ups will be excluded from the study. Patients enrolled in the study will undergo three evaluations. The first evaluation will be performed before the treatment and the second evaluation will be performed after the treatment. The third evaluation will be performed 3 months after the end of the treatment. Demographic information such as age, height, weight, body mass index, medications used and duration of illness will be documented before the intervention. The patient's pain during rest and activity will be evaluated using the visual analog scale (VAS). The patient's fatigue status will be evaluated using the fatigue severity scale (FSS). The emotional state of the patient will be evaluated using the hospital anxiety and depression scale (HADS). The functional capacity of the patient will be evaluated using a 6-minute walking test and a 30-second sitting test. The patient's flexibility will be evaluated using the sitting access test. The patient's hand grip strength will be evaluated using a hand dynamometer. The patient's sleep quality will be evaluated using the Jenkins sleep scale (JSS). The quality of life of the patient will be evaluated using the systemic lupus erythematosus quality of life scale (SLEQoL). The functional status of the patient will be evaluated using the health assessment questionnaire (HAQ).

Study Type

Interventional

Enrollment (Estimated)

30

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 (Türkiye)
    • Saricam
      • Adana, Saricam, Turkey (Türkiye), 01250
        • Çukurova 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being a woman between the 18 Years to 65 Years ,
  • meeting the American College of Rheumatology SLE diagnostic criteria,
  • having low disease activity (SLEDAI ≤4),
  • agreeing to participate in the study

Exclusion Criteria:

  • presence of malignancy, pregnancy, change of treatment within the last 3 months,
  • use of steroids equivalent to >16 mg prednisolone for the last 3 months, - -
  • have other rheumatic diseases,
  • have a regular exercise habit (physical activity more than two times a week),
  • have a disease that restricts physical activity (such as neurological disorder, orthopedic disorder, cognitive disorder, immobility),
  • have serious heart, lung or kidney involvement,
  • uncontrolled hypertension,
  • severe anemia (hb <8 g/dL),
  • having undergone orthopedic surgery in 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: Intervention group
The intervention group will participate in supervised clinical Pilates exercises. These exercises will be administered in the form of group sessions, which are to be held twice per week. In addition to the home exercise program, which is to be followed for a period of eight weeks.
Other: Clinical Pilates Training

Warm-up (5 min) Segmental extremity movements Centering Roll down

Pilates exercises (35 min) One leg stretch Double leg stretch Shoulder bridge Chest lift Hundreds Side band Arm opening Cobra Swimming Push-up

Cool-down (5 min) Cat stretching Camel stretching Relaxation exercises

Other: Home exercise program
This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.
Active Comparator: Control group
The control group will be provided with a home exercise program. This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.
Other: Home exercise program
This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue status (Fatigue Severity Scale)
Time Frame: 5 months
The patient's fatigue status will be evaluated using the fatigue severity scale (FSS). The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score (Visual Analog Scale)
Time Frame: 5 months
The patient's pain during rest and activity will be evaluated using the visual analog scale (VAS). The visual analogue scale is a psychometric response scale that can be used in questionnaires. It is a measurement tool for subjective characteristics or attitudes that cannot be measured directly. When responding to a VAS item, respondents indicate their level of agreement with a statement by indicating a position along a continuous line between two endpoints.
5 months
Emotional state (Hospital Anxiety and Depression Scale)
Time Frame: 5 months
The emotional state of the patient will be evaluated using the hospital anxiety and depression scale (HADS).
5 months
Functional capacity (6-minute walking test, 30-second sitting test, Handgrip measurement)
Time Frame: 5 months
The functional capacity of the patient will be evaluated using a 6-minute walking test and a 30-second sitting test. The patient's flexibility will be evaluated using the sitting access test. The patient's hand grip strength will be evaluated using a hand dynamometer.
5 months
Sleep quality (Jenkins sleep scale)
Time Frame: 5 months
The patient's sleep quality will be evaluated using the Jenkins sleep scale (JSS).
5 months
SLE quality of life (Systemic lupus erythematosus quality of life scale)
Time Frame: 5 months
The quality of life of the patient will be evaluated using the systemic lupus erythematosus quality of life scale (SLEQoL). SLEQoL is a lupus-specific scale developed in the United Kingdom. It is based on patient needs and the ability of patients to meet their needs. It is a simple questionnaire consisting of 25 items related to symptoms, functioning and disease-related issues. A 'correct' answer to the questions is considered 1 point and an 'incorrect' answer is considered 0 point. The total score is between 0 and 25, with a higher score indicating a lower quality of life.
5 months
Functional status (Health assessment questionnaire)
Time Frame: 5 months
The functional status of the patient will be evaluated using the health assessment questionnaire (HAQ).
5 months

Collaborators and Investigators

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

Sponsor

Emir İbrahim IŞIK

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)

March 7, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLE_KP_01
  • CukurovaU (Other Identifier: CukurovaU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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 Lupus Erythematosus, Systemic

Clinical Trials on Clinical Pilates Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe