Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

NCT ID: NCT05392790

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-12-30

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aerobic exercise plus progressive resisted exercise group

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

Group Type: EXPERIMENTAL

Calcium and Vit D

Intervention Type: DRUG

Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Aerobic exercises

Intervention Type: OTHER

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.

Progressive resisted exercise training

Intervention Type: OTHER

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.

Aerobic exercise group

Will receive aerobic exercise plus traditional care.

Group Type: EXPERIMENTAL

Calcium and Vit D

Intervention Type: DRUG

Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Aerobic exercises

Intervention Type: OTHER

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.

Progressive resisted exercise group

Will receive progressive resisted exercise

Group Type: EXPERIMENTAL

Calcium and Vit D

Intervention Type: DRUG

Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Progressive resisted exercise training

Intervention Type: OTHER

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.

Control group

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

Group Type: OTHER

Calcium and Vit D

Intervention Type: DRUG

Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Interventions

Calcium and Vit D

Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.

Intervention Type: DRUG

Aerobic exercises

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.

Intervention Type: OTHER

Progressive resisted exercise training

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.

Intervention Type: OTHER

Other Intervention Names

Traditional medical treatment; Bi phosphnate; Traditional medical treatment

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadaya M Eladl, PhD

Role: PRINCIPAL_INVESTIGATOR

Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Locations

Nesma Morgan Allam

Tanta, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003638

Identifier Type: -

Identifier Source: org_study_id