Clinical trial NCT06166199: Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus
Official title: Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Physical exercise
High-intensity interval training
Resistance training
Quality of life
Aerobic capacity
Fatigue
Disease activity
Patients experiences
Inflammatory markers
Muscle function
Depressive symptoms
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Rheumatism Association
name: Region Örebro County
name: County Council of Norrbotten, Sweden
name: Karolinska University Hospital
First posted: 2023-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised-controlled single blinded multicenter study. The trial will follow the Consolidated Standards of Reporting Trials, www.consort-statement.org and comprise two arms.

After information of the study and written informed consent, the patients are block-randomised (from the aerobic capacity results) to either an intervention group doing supervised high-intensity interval training combined with resistance training or a control group. Both groups receive standard care.
Primary purpose: TREATMENT

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, disease activity and immune function in patients with SLE with low to moderate disease activity and no to little organ damage. The aim is also to explore and describe patient's experiences of the training.

The research questions are:

1. What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding aerobic capacity, muscle function, physician and patient reported disease activity, fatigue, depressive symptoms, and quality of life?
2. What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding inflammatory markers such as interleukin 6 and 10 and interferon molecules? Both acute exercise test (maximal ergometercycle test) effects as well as the long term effects of training will be evaluated.
3. How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?

Eligibility criteria: Inclusion Criteria:

* ≥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 Criteria:

* 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

Primary outcomes:
measure: Aerobic capacity
timeFrame: Baseline, months 3 and 6
measure: Physical capacity
timeFrame: Baseline, months 3 and 6
Secondary outcomes:
measure: Muscle function upper extremity
timeFrame: Baseline, months 3 and 6
measure: Self-reported disease activity
timeFrame: Baseline, months 3 and 6
measure: Fatigue
timeFrame: Baseline, months 3 and 6
measure: Anxiety and depressive symptoms
timeFrame: Baseline, months 3 and 6
measure: Quality of life in SLE
timeFrame: Baseline, months 3 and 6
measure: Generic Quality of life
timeFrame: Baseline, months 3 and 6
measure: Quality of life and health status
timeFrame: Baseline, months 3 and 6
measure: Disease activity
timeFrame: Baseline, months 3 and 6
measure: Inflammatory markers
timeFrame: Baseline, months 3 and 6
measure: Health status
timeFrame: Baseline, months 3 and 6
measure: Blood pressure
timeFrame: Baseline, month 3 and 6
Other outcomes:
measure: Organ damage
timeFrame: Baseline and 6 months
measure: Demographical, clinical and lifestyle behaviour data including age, gender, ethnic origin, and smoking status as well as other for the project important information about the disease such as autoantibody profiles and pharmacological treatment
timeFrame: Baseline. For some variables, such as medical treatment, also months 3 and 6
measure: Physical activity
timeFrame: Baseline, months 3 and 6
measure: Activity-minutes and sitting behaviour
timeFrame: Baseline, months 3 and 6
measure: Weight
timeFrame: Baseline, months 3 and 6
measure: Height
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline, months 3 and 6
measure: Muscle function lower extremity
timeFrame: Baseline, months 3 and 6
Locations:
city: Stockholm
country: Sweden
facility: Carina Boström
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Carina M Boström, Dr
role: PRINCIPAL_INVESTIGATOR
References: