Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Registration Number
- NCT05392790
- Lead Sponsor
- Cairo University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic exercise group Calcium and Vit D Will receive aerobic exercise plus traditional care. Progressive resisted exercise group Calcium and Vit D Will receive progressive resisted exercise Aerobic exercise plus progressive resisted exercise group Calcium and Vit D Will receive aerobic exercise, progressive resisted exercise in addition to traditional care. Progressive resisted exercise group Progressive resisted exercise training Will receive progressive resisted exercise Aerobic exercise group Aerobic exercises Will receive aerobic exercise plus traditional care. Control group Calcium and Vit D Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate. Aerobic exercise plus progressive resisted exercise group Aerobic exercises Will receive aerobic exercise, progressive resisted exercise in addition to traditional care. Aerobic exercise plus progressive resisted exercise group Progressive resisted exercise training Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.
- Primary Outcome Measures
Name Time Method Bone Mineral Density follow up after 3 months It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray
- Secondary Outcome Measures
Name Time Method Muscle strength assessment follow up after 3 months 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).
Level of physical activity follow up after 3 months 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.
Quality of life (36-Item Short Form Health Survey) follow up after 3 months 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.
Trial Locations
- Locations (1)
Nesma Morgan Allam
🇪🇬Tanta, Egypt