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Completed

NCT Number: NCT05392790

Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Skin and Connective Tissue Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nesma Morgan Allam

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Traditional medical treatment

Calcium and Vit D

Drug

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

Other names: Bi phosphnate

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.

Other names: Traditional medical treatment

Primary outcomes

  1. Bone Mineral Density

    Time frame: 6 months

    It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray absorptiometry (GE Healthcare or Hologic, USA)

  2. Bone Mineral Density

    Time frame: follow up after 3 months

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

Secondary outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: follow up after 3 months

    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.

  3. Muscle strength assessment

    Time frame: 6 months

    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).

  4. Muscle strength assessment

    Time frame: follow up after 3 months

    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).

  5. Level of physical activity

    Time frame: 6 months

    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. Level of physical activity

    Time frame: follow up after 3 months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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