Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

Cairo University (CU)

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Calcium and Vit D; Other: Progressive resisted exercise training; Other: Aerobic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05392790

P.T.REC/012/003638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 4 patient groups

Aerobic exercise plus progressive resisted exercise group

Experimental group

Description:

Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.

Treatment:

Other: Aerobic exercises

Other: Progressive resisted exercise training

Drug: Calcium and Vit D

Aerobic exercise group

Experimental group

Description:

Will receive aerobic exercise plus traditional care.

Treatment:

Other: Aerobic exercises

Drug: Calcium and Vit D

Progressive resisted exercise group

Experimental group

Description:

Will receive progressive resisted exercise

Treatment:

Other: Progressive resisted exercise training

Drug: Calcium and Vit D

Control group

Other group

Description:

Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Treatment:

Drug: Calcium and Vit D