Status:
RECRUITING
Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Swedish Rheumatism Association
Region Örebro County
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus
Detailed Description
The overall aim of this randomized controlled study, is to evaluate the safety and effects of HIIT combined with resistance exercises on aerobic capacity, muscle function, patient reported outcomes, d...
Eligibility Criteria
Inclusion
- ≥18 years old
- Fulfilment of the 1982 American College of Rheumatology (ACR) criteria; or 2012 Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index (DI)) classification criteria; or EULAR/ACR criteria; or patients that have received the diagnosis SLE on clinical grounds
- Low to moderate disease activity, for example defined as a score of ≤5 in the clinical version of the SLE Disease Activity Index 2000 (SLEDAI-2K), i.e., excluding the serological descriptors (anti-dsDNA positivity and low complement levels)
- Low/minimal or no organ damage, for example defined as a score of ≤3 in the SLICC/ACR DI
- Stable pharmacological treatment
- The ability to perform a maximal ergometercycle exercise test
- Be able to read and understand Swedish
Exclusion
- Symptoms or signs of cerebro-vascular disease, pulmonary embolus, pulmonary hypertension, pulmonary fibrosis, cardiovascular disease, angina pectoris, myocardial infarction, dyspnea at rest, uncontrolled blood pressure and uncontrolled diabetes within one year prior to study entry. Chronic kidney disease with
- Patients who fulfil the absolute contraindications for maximal exercise testing according to American Heart Association
- Patients who cannot perform a maximal ergometercycle exercise test due to the disease
- Diseases or other conditions that strongly reduce the ability to exercise or that exercise is not recommended
- Patients who perform regular aerobic fitness training and muscle strength exercise sessions at fixed times, \>1 time/week
- Pregnancy
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06166199
Start Date
November 1 2022
End Date
December 31 2026
Last Update
December 12 2023
Active Locations (1)
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1
Carina Boström
Stockholm, Huddinge, Sweden, 141 83