Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

NCT05392790 | Completed

• 1 other identifier: P.T.REC/012/003638
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Progressive Resisted Exercise; Aerobic Exercise; Osteoporosis; systemic Lupus Erythmatosus

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• Bone Mineral Density

  It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray

  follow up after 3 months

Secondary Outcomes (6)

• Quality of life (36-Item Short Form Health Survey)

  6 months

• Quality of life (36-Item Short Form Health Survey)

  follow up after 3 months

• Muscle strength assessment

  6 months

• Muscle strength assessment

  follow up after 3 months

• Level of physical activity

  6 months

Study Arms (4)

Aerobic exercise plus progressive resisted exercise group

EXPERIMENTAL

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

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

Aerobic exercise group

EXPERIMENTAL

Will receive aerobic exercise plus traditional care.

Drug: Calcium and Vit D; Other: Aerobic exercises

Progressive resisted exercise group

EXPERIMENTAL

Will receive progressive resisted exercise

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.

Drug: Calcium and Vit D

Interventions

Progressive resisted exercise training 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.

Also known as: Traditional medical treatment

Aerobic exercise plus progressive resisted exercise group; Progressive resisted exercise group

Calcium and Vit D DRUG

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

Also known as: Bi phosphnate

Aerobic exercise group; Aerobic exercise plus progressive resisted exercise group; Control group; Progressive resisted exercise group

Aerobic exercises 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.

Also known as: Traditional medical treatment

Aerobic exercise group; Aerobic exercise plus progressive resisted exercise group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Systemic lupus erythmatosus is most common in females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Nesma Morgan Allam

Tanta, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Osteoporosis

Interventions

Calcium; Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hadaya M Eladl, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: May 23, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 20, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: Study protocol

Locations

EG (1)