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Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Progressive resisted exercise training
Calcium and Vit D
Aerobic exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Progressive Resisted Exercise, Aerobic Exercise, Osteoporosis, systemic Lupus Erythmatosus

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Nesma Morgan AllamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Aerobic exercise plus progressive resisted exercise group

Aerobic exercise group

Progressive resisted exercise group

Control group

Arm Description

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

Will receive aerobic exercise plus traditional care.

Will receive progressive resisted exercise

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.

Full Information

First Posted
May 23, 2022
Last Updated
March 1, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05392790
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Progressive Resisted Exercise, Aerobic Exercise, Osteoporosis, systemic Lupus Erythmatosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise plus progressive resisted exercise group
Arm Type
Experimental
Arm Description
Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
Will receive aerobic exercise plus traditional care.
Arm Title
Progressive resisted exercise group
Arm Type
Experimental
Arm Description
Will receive progressive resisted exercise
Arm Title
Control group
Arm Type
Other
Arm Description
Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.
Intervention Type
Other
Intervention Name(s)
Progressive resisted exercise training
Other Intervention Name(s)
Traditional medical treatment
Intervention Description
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
Drug
Intervention Name(s)
Calcium and Vit D
Other Intervention Name(s)
Bi phosphnate
Intervention Description
Traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Other Intervention Name(s)
Traditional medical treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray absorptiometry (GE Healthcare or Hologic, USA)
Time Frame
6 months
Title
Bone Mineral Density
Description
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray
Time Frame
follow up after 3 months
Secondary Outcome Measure Information:
Title
Quality of life (36-Item Short Form Health Survey)
Description
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.
Time Frame
6 months
Title
Quality of life (36-Item Short Form Health Survey)
Description
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.
Time Frame
follow up after 3 months
Title
Muscle strength assessment
Description
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).
Time Frame
6 months
Title
Muscle strength assessment
Description
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).
Time Frame
follow up after 3 months
Title
Level of physical activity
Description
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.
Time Frame
6 months
Title
Level of physical activity
Description
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.
Time Frame
follow up after 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Systemic lupus erythmatosus is most common in females.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesma M Allam, PhD
Phone
00201281968332
Email
dr.nesma2011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadaya M Eladl, PhD
Organizational Affiliation
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nesma Morgan Allam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Study protocol

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Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

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