Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

Progressive Resisted Exercise Program Combined with Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: Progressive resisted exercise training; Drug: Calcium and Vit D; Other: Aerobic exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Nesma Morgan Allam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise plus progressive resisted exercise group; Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.	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.; Other Names: Traditional medical treatment; Drug: Calcium and Vit D; Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.; Other Names: Bi phosphnate; Other: 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.; Other Names: Traditional medical treatment
Experimental: Aerobic exercise group; Will receive aerobic exercise plus traditional care.	Drug: Calcium and Vit D; Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.; Other Names: Bi phosphnate; Other: 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.; Other Names: Traditional medical treatment
Experimental: Progressive resisted exercise group; Will receive progressive resisted exercise	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.; Other Names: Traditional medical treatment; Drug: Calcium and Vit D; Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.; Other Names: Bi phosphnate
Other: Control group; Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.	Drug: Calcium and Vit D; Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.; Other Names: Bi phosphnate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (36-Item Short Form Health Survey)	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.	6 months
Quality of life (36-Item Short Form Health Survey)	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.	follow up after 3 months
Muscle strength assessment	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).	6 months
Muscle strength assessment	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).	follow up after 3 months
Level of physical activity	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.	6 months
Level of physical activity	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.	follow up after 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hadaya M Eladl, PhD, Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Osteoporosis; Progressive Resisted Exercise; systemic Lupus Erythmatosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: P.T.REC/012/003638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No