Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Aerobic capacity
研究概览
简要总结
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
详细描述
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:
- 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?
- 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.
- How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessors are blinded for which patient is randomised to which group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
结局指标
主要结局
Aerobic capacity
时间窗: Baseline, months 3 and 6
Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test
Physical capacity
时间窗: Baseline, months 3 and 6
Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test
次要结局
- Muscle function upper extremity(Baseline, months 3 and 6)
- Health status(Baseline, months 3 and 6)
- Anxiety and depressive symptoms(Baseline, months 3 and 6)
- Blood pressure(Baseline, month 3 and 6)
- Self-reported disease activity(Baseline, months 3 and 6)
- Inflammatory markers(Baseline, months 3 and 6)
- Fatigue(Baseline, months 3 and 6)
- Quality of life in SLE(Baseline, months 3 and 6)
- Generic Quality of life(Baseline, months 3 and 6)
- Quality of life and health status(Baseline, months 3 and 6)
- Disease activity(Baseline, months 3 and 6)
研究者
Carina Boström
Associate professor, university lecturer
Karolinska Institutet