Clinical trial NCT05392790: Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus
Official title: Progressive Resisted Exercise Program Combined with Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Progressive Resisted Exercise
Aerobic Exercise
Osteoporosis
systemic Lupus Erythmatosus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 6 months
measure: Bone Mineral Density
timeFrame: follow up after 3 months
Secondary outcomes:
measure: Quality of life (36-Item Short Form Health Survey)
timeFrame: 6 months
measure: Quality of life (36-Item Short Form Health Survey)
timeFrame: follow up after 3 months
measure: Muscle strength assessment
timeFrame: 6 months
measure: Muscle strength assessment
timeFrame: follow up after 3 months
measure: Level of physical activity
timeFrame: 6 months
measure: Level of physical activity
timeFrame: follow up after 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Nesma Morgan Allam
Study officials:
affiliation: Assisstant professor of physical therapy for surgery, Faculty of physical therapy
name: Hadaya M Eladl, PhD
role: PRINCIPAL_INVESTIGATOR
References: