Systemic Lupus ErythematosusNCT05392790
Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus
A study testing Progressive resisted exercise training, Calcium and Vit D and Aerobic exercises in people with Systemic Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
Trial summary
systemic lupus erythematosus (SLE) is the most common autoimmune disease in women of childbearing age. Promoting physical activity is a major national priority for the general population, including patients with chronic diseases. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Progressive resisted exercise training, Calcium and Vit D and Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of systemic lupus erythematosus by the classification criteria ACRa and the 2019 EULARb/ACR Classification Criteria for systemic lupus erythematosus
- Systemic Lupus Erythematosus Disease Activity Index ≥4
- For 30 day prior, stable immunosuppressive therapy with steroid (0-20 mg/day) or other immunosuppressive medication such as hydroxychloroquine, chloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, belimumab, rituximab
Who cannot join
- Those who are pregnant.
- Patients with active lupus nephritis, cardiovascular dysfunction, rhythm and conduction disorders.
- Patients with musculoskeletal disturbances; kidney and pulmonary involvements; peripheral neuropathy and fibromyalgia.
- Use of tobacco; treatment with lipid-lowering, chronotropic or antihypertensive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resisted Exercise Program Combined with Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial
systemic lupus erythematosus (SLE) is the most common autoimmune disease in women of childbearing age. Promoting physical activity is a major national priority for the general population, including patients with chronic diseases. The aim of this study is to investigate the efficiency of combined effect of progressive resisted exercise with aerobic exercise for bone mineral density, quality of life, muscle strength and physical activity for patients with SLE.
Read the detailed description
The following factors were found to be significantly related to lower BMD by univariate analysis: Caucasian race, older age at diagnosis, higher age at the time of the first DXA, longer disease duration, higher cumulative corticosteroid dose, lower serum levels of 25(OH)D, higher SLE Damage Index score, and postmenopausal status. In the multivariate analysis only the following factors were significant: Caucasian race, increased number of pregnancies, postmenopausal status, higher SLE Damage Index, and higher cumulative corticosteroid dose.
As the quality of life among patients with SLE not fully associated with SLE disease activity, pharmacologic treatments that are effective for SLE disease activity might not be able to improve quality of life in these patients Therefore, the benefit of nonpharmacological therapies on quality of life has been explored.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Progressive resisted exercise training, Calcium and Vit D, Aerobic exercises
- Keywords
- Progressive Resisted Exercise, Aerobic Exercise, Osteoporosis, systemic Lupus Erythmatosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resisted exercise trainingOther
Also called Traditional medical treatment
Progressive resisted exercises will be started with the 8 maximum repetition test (8 RM) performed at progressive intensities. The subject will perform the 8 RM test at the beginning and the end of each cycle over the two-month training period. Each training session lasts sixty minutes and will be performed three times per week on alternate days.
Calcium and Vit DDrug
Also called Bi phosphnate
Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.
Aerobic exercisesOther
Also called Traditional medical treatment
Aerobic exercises will be applied at 70 - 80% of their maximum heart rate. Trained health professionals supervised the exercise program. Each exercise session will begin with a 5-10-minute warm-up, will be followed by 20 -30 minutes of aerobic activity, and will be concluded with a 5-10-minute cool-down period.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise plus progressive resisted exercise group | Experimental | Will receive aerobic exercise, progressive resisted exercise in addition to traditional care. Receives: Other: Progressive resisted exercise training; Drug: Calcium and Vit D; Other: Aerobic exercises |
| Aerobic exercise group | Experimental | Will receive aerobic exercise plus traditional care. Receives: Drug: Calcium and Vit D; Other: Aerobic exercises |
| Progressive resisted exercise group | Experimental | Will receive progressive resisted exercise Receives: Other: Progressive resisted exercise training; Drug: Calcium and Vit D |
| Control group | Other | Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate. Receives: Drug: Calcium and Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray absorptiometry (GE Healthcare or Hologic, USA)
Measured: 6 months
Bone Mineral Density
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray
Measured: follow up after 3 months
Secondary outcomes (6)
Quality of life (36-Item Short Form Health Survey)
HRQoL using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The SF-36 is a generic measure of HRQoL that contains 36 items grouped into: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
Measured: 6 months
Quality of life (36-Item Short Form Health Survey)
HRQoL using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The SF-36 is a generic measure of HRQoL that contains 36 items grouped into: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
Measured: follow up after 3 months
Muscle strength assessment
will be measured using the Isometric strength. Isometric strength of two lower extremity muscle groups (knee flexors and extensors) will be sampled using an isokinetic exercise machine, the CYBEX (CYBEX International, Inc., Medway, MA).
Measured: 6 months
Muscle strength assessment
will be measured using the Isometric strength. Isometric strength of two lower extremity muscle groups (knee flexors and extensors) will be sampled using an isokinetic exercise machine, the CYBEX (CYBEX International, Inc., Medway, MA).
Measured: follow up after 3 months
Level of physical activity
Patients will be asked to walk up and down a designated corridor in the medical practice for 2min. They will be told to walk at their usual pace and to turn around at the ends of the corridor without stopping.
Measured: 6 months
Level of physical activity
Patients will be asked to walk up and down a designated corridor in the medical practice for 2min. They will be told to walk at their usual pace and to turn around at the ends of the corridor without stopping.
Measured: follow up after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start23 May 2022
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Principal investigator, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392790
- Sponsor's protocol ID
- P.T.REC/012/003638
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resisted Exercise Program Combined with Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05392790
- Acronym / sponsor ID
- P.T.REC/012/003638
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Progressive Resisted Exercise, Aerobic Exercise, Osteoporosis, systemic Lupus Erythmatosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 26 May 2022 (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 the most common autoimmune disease in women of childbearing age. Promoting physical activity is a major national priority for the general population, including patients with chronic diseases. The aim of this study is to investigate the efficiency of combined effect of progressive resisted exercise with aerobic exercise for bone mineral density, quality of life, muscle strength and physical activity for patients with SLE.
Detailed description
The following factors were found to be significantly related to lower BMD by univariate analysis: Caucasian race, older age at diagnosis, higher age at the time of the first DXA, longer disease duration, higher cumulative corticosteroid dose, lower serum levels of 25(OH)D, higher SLE Damage Index score, and postmenopausal status. In the multivariate analysis only the following factors were significant: Caucasian race, increased number of pregnancies, postmenopausal status, higher SLE Damage Index, and higher cumulative corticosteroid dose.
As the quality of life among patients with SLE not fully associated with SLE disease activity, pharmacologic treatments that are effective for SLE disease activity might not be able to improve quality of life in these patients Therefore, the benefit of nonpharmacological therapies on quality of life has been explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise plus progressive resisted exercise group | Experimental | Other: Progressive resisted exercise training, Drug: Calcium and Vit D, Other: Aerobic exercisesWill receive aerobic exercise, progressive resisted exercise in addition to traditional care. |
| Aerobic exercise group | Experimental | Drug: Calcium and Vit D, Other: Aerobic exercisesWill receive aerobic exercise plus traditional care. |
| Progressive resisted exercise group | Experimental | Other: Progressive resisted exercise training, Drug: Calcium and Vit DWill receive progressive resisted exercise |
| Control group | Other | Drug: Calcium and Vit DWill receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of systemic lupus erythematosus by the classification criteria ACRa and the 2019 EULARb/ACR Classification Criteria for systemic lupus erythematosus
- Systemic Lupus Erythematosus Disease Activity Index ≥4
- For 30 day prior, stable immunosuppressive therapy with steroid (0-20 mg/day) or other immunosuppressive medication such as hydroxychloroquine, chloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, belimumab, rituximab
Key exclusion criteria (4 listed)
- Those who are pregnant.
- Patients with active lupus nephritis, cardiovascular dysfunction, rhythm and conduction disorders.
- Patients with musculoskeletal disturbances; kidney and pulmonary involvements; peripheral neuropathy and fibromyalgia.
- Use of tobacco; treatment with lipid-lowering, chronotropic or antihypertensive drugs
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 |
|---|---|---|
| Progressive resisted exercise trainingAlso: Traditional medical treatmentProgressive resisted exercises will be started with the 8 maximum repetition test (8 RM) performed at progressive intensities. The subject will perform the 8 RM test at the beginning and the end of each cycle over the two-month training period. Each training session lasts sixty minutes and will be performed three times per week on alternate days. | Other | Aerobic exercise plus progressive resisted exercise group, Progressive resisted exercise group |
| Calcium and Vit DAlso: Bi phosphnateTraditional medical treatment in the form of Calcium, Vit D and Bi phosphnate. | Drug | Aerobic exercise group, Aerobic exercise plus progressive resisted exercise group, Control group, Progressive resisted exercise group |
| Aerobic exercisesAlso: Traditional medical treatmentAerobic exercises will be applied at 70 - 80% of their maximum heart rate. Trained health professionals supervised the exercise program. Each exercise session will begin with a 5-10-minute warm-up, will be followed by 20 -30 minutes of aerobic activity, and will be concluded with a 5-10-minute cool-down period. | Other | Aerobic exercise group, Aerobic exercise plus progressive resisted exercise group |
Primary outcome
Bone Mineral Density
Time frame: 6 months
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray absorptiometry (GE Healthcare or Hologic, USA)
Bone Mineral Density
Time frame: follow up after 3 months
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray
6 secondary outcomes
Quality of life (36-Item Short Form Health Survey)
Time frame: 6 months
Quality of life (36-Item Short Form Health Survey)
Time frame: follow up after 3 months
Muscle strength assessment
Time frame: 6 months
Muscle strength assessment
Time frame: follow up after 3 months
Level of physical activity
Time frame: 6 months
Level of physical activity
Time frame: follow up after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Yes. Study results
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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. This study is not recruiting at the moment.
Hadaya M Eladl, PhD principal investigator
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resisted exercise training, Calcium and Vit D and Aerobic exercises in people with Systemic Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone Mineral Density (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.