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

NCT07394361 | Enrolling By Invitation

• 2 other identifiers: SLE_KP_01CukurovaU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Lupus; Clinical Pilates

Outcome Measures

Primary Outcomes (1)

• Fatigue status (Fatigue Severity Scale)

  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 Outcomes (6)

• Pain score (Visual Analog Scale)

  5 months

• Emotional state (Hospital Anxiety and Depression Scale)

  5 months

• Functional capacity (6-minute walking test, 30-second sitting test, Handgrip measurement)

  5 months

• Sleep quality (Jenkins sleep scale)

  5 months

• SLE quality of life (Systemic lupus erythematosus quality of life scale)

  5 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Other: Home exercise program

Control group

ACTIVE COMPARATOR

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

Interventions

Clinical Pilates Training OTHER

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

Intervention group

Home exercise program OTHER

This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only female participants will be included to the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emir İbrahim IŞIK: lead

Study Sites (1)

Cukurova University

Adana, Saricam, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• Hashemi, S., Farahbakhsh, S., Fallahi, A., Daryanoosh, F., Babaei Beigi, M. A., & Jamshidian Tehrani, N. (2024). Aerobic and Anaerobic Exercise Benefits for Lupus: Fatigue, Fitness, and Life Quality. Iranian Rehabilitation Journal, 22(3), 499-508.

  BACKGROUND

• Ismail AMA, Saad AE, Abd-Elrahman NAF, Elfahl AMA. Response of Lipid Profile to Laser Acupuncture along with Diet and Pilates Exercise in Obese Women with Systemic Lupus Erythematosus: a Randomized Controlled Trial. J Acupunct Meridian Stud. 2023 Aug 31;16(4):152-158. doi: 10.51507/j.jams.2023.16.4.152.

  PMID: 37609770 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

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: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: February 6, 2026
• Study Start: March 7, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-04

Locations

TU (1)