Lupus Erythematosus, SystemicNCT07394361
The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women With Systemic Lupus Erythematosus
A study testing Clinical Pilates Training and Home exercise program in people with Lupus Erythematosus, Systemic, run by Emir İbrahim IŞIK at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Clinical Pilates Training and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- uncontrolled hypertension,
- severe anemia (hb <8 g/dL),
- having undergone orthopedic surgery in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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:
- To examine the effect of a home exercise program on physical and psychological parameters in patients with SLE.
- 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.
- 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).
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Clinical Pilates Training, Home exercise program
- Keywords
- Lupus, Clinical Pilates
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pilates TrainingOther
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
Home exercise programOther
This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (6)
Pain score (Visual Analog Scale)
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.
Measured: 5 months
Emotional state (Hospital Anxiety and Depression Scale)
The emotional state of the patient will be evaluated using the hospital anxiety and depression scale (HADS).
Measured: 5 months
Functional capacity (6-minute walking test, 30-second sitting test, Handgrip measurement)
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.
Measured: 5 months
Sleep quality (Jenkins sleep scale)
The patient's sleep quality will be evaluated using the Jenkins sleep scale (JSS).
Measured: 5 months
SLE quality of life (Systemic lupus erythematosus quality of life scale)
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.
Measured: 5 months
Functional status (Health assessment questionnaire)
The functional status of the patient will be evaluated using the health assessment questionnaire (HAQ).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start7 Mar 2025
- Primary completion30 Jan 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emir İbrahim IŞIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emir İbrahim IŞIK, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394361
- Sponsor's protocol ID
- SLE_KP_01
- Other IDs
- CukurovaU
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 37609770
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07394361
- Acronym / sponsor ID
- SLE_KP_01
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Lupus, Clinical Pilates
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Emir İbrahim IŞIKUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To examine the effect of a home exercise program on physical and psychological parameters in patients with SLE.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Clinical Pilates Training, Other: Home exercise programThe 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. |
| Control group | Active comparator | Other: Home exercise programThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pilates TrainingWarm-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 | Intervention group |
| Home exercise programThis program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks. | Other | Control group, Intervention group |
Primary outcome
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.
6 secondary outcomes
Pain score (Visual Analog Scale)
Time frame: 5 months
Emotional state (Hospital Anxiety and Depression Scale)
Time frame: 5 months
Functional capacity (6-minute walking test, 30-second sitting test, Handgrip measurement)
Time frame: 5 months
Sleep quality (Jenkins sleep scale)
Time frame: 5 months
SLE quality of life (Systemic lupus erythematosus quality of life scale)
Time frame: 5 months
Functional status (Health assessment questionnaire)
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- BackgroundHashemi, 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.
- Results publication: PubMed 37609770Ismail 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates Training and Home exercise program in people with Lupus Erythematosus, Systemic, run by Emir İbrahim IŞIK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue status (Fatigue Severity Scale) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.