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

Overview

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?

Interventions

• Behavioral HIIT combined with resistance training
  Patients with SLE will undergo supervised HIIT on an ergometercycle, 4 x 4 minutes interval, (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week. Between months 3 and 6 the patient

Primary outcome measures

• Aerobic capacity [Time frame: Baseline, months 3 and 6]
• Physical capacity [Time frame: Baseline, months 3 and 6]

Secondary outcome measures (11)

• Muscle function upper extremity [Time frame: Baseline, months 3 and 6]
• Self-reported disease activity [Time frame: Baseline, months 3 and 6]
• Fatigue [Time frame: Baseline, months 3 and 6]
• Anxiety and depressive symptoms [Time frame: Baseline, months 3 and 6]
• Quality of life in SLE [Time frame: Baseline, months 3 and 6]
• Generic Quality of life [Time frame: Baseline, months 3 and 6]
• Quality of life and health status [Time frame: Baseline, months 3 and 6]
• Disease activity [Time frame: Baseline, months 3 and 6]
• Inflammatory markers [Time frame: Baseline, months 3 and 6]
• Health status [Time frame: Baseline, months 3 and 6]
• Blood pressure [Time frame: Baseline, month 3 and 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Carina Boström — Stockholm

Identifiers

NCT: NCT06166199 · 2021-05523-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗