NCT05768165进行中（未招募）不适用
Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
Vastra Gotaland Region4 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年8月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- Cardiopulmonary function
研究概览
简要总结
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Single blinded
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
- •Disease duration >1 year
- •Age (range 20-60 years)
- •Stable medication on anti- rheumatic drugs for >3 months
- •Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28)
排除标准
- •Cerebrovascular diseases
- •Severe hypertension
- •Chronic obstructive pulmonary disease or other severe pulmonary diseases
- •Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
- •Arthroplasty of large joints
- •Inability to manage Cardiopulmonary Exercise Testing (CPET)
- •Pregnancy
- •Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months
- •Inability to speak or read Swedish.
研究组 & 干预措施
Intervention group
Experimental
Cardiorespiratory and strength exercise training 2-3 sessions per week
干预措施: High intensity exercise (Behavioral)
Care as usual
No Intervention
Care as usual and information of health enhancing physical activity according to general recommendations
结局指标
主要结局
Cardiopulmonary function
时间窗: 0 -12 weeks
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)
次要结局
- Vascular function(0-12 weeks)
- Level of disease activity(0-12 months)
- Homeostatic model assessment of insulin resistance (HOMA IR)(0-12 weeks)
- Glycosylation level of hemoglobin (HbA1c)(0-12 weeks)
- Level of blood lipids(0-12 weeks)
- Erythrocyte Sedimentation Rate (ESR)(0-12 months)
- C-Reactive Protein (CRP)(0-12 months)
- Cytokine levels(0-12 weeks)
- Muscle function of lower extremities(0-12 weeks)
- Hand-grip force(0-12 weeks)
- Self-reported physical activity(0-12 months)
- Objective assessment of physical activity(0-12 months)
- Pain intensity(0-12 months)
- Waist circumference(0-12 weeks)
- Global health(0-12 months)
- Fatigue(0-12 months)
- Sleep(0-12 months)
- Attitude to exercise(0-12 months)
- Body compositions(0-12 weeks)
- Activity limitations(0-12 months)
研究者
研究点 (4)
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