The Effect of High-intensity Intermittent Exercise and Moderate-intensity Continuous Exercise on Serum Irisin Levels, Disease Activity, Functional Status, and Quality of Life in Patients With Axial Spondyloarthritis: a Prospective, Randomized Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Kirsehir Ahi Evran Universitesi
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- serum irisin level
概览
简要总结
This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
详细描述
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting young individuals, with a prevalence of 0.3-1.4%. The main features of the disease include inflammatory back pain, reduced joint mobility, and functional disability. In addition, accumulating evidence over recent years has demonstrated that inflammatory rheumatic diseases are associated with an increased risk of cardiovascular disease. Exercise constitutes an important component of the management of inflammatory rheumatic diseases and is widely used to reduce pain and improve joint mobility.
Irisin is a myokine secreted by skeletal muscle through the cleavage of the membrane protein fibronectin type III domain-containing protein 5 (FNDC-5). Irisin is considered a mediator of exercise-induced metabolic benefits and has been shown to exert protective effects in several non-metabolic diseases. At the molecular level, irisin contributes to increased energy expenditure and metabolic regulation by promoting the browning of white adipose tissue. Previous studies have demonstrated that serum irisin levels increase following exercise.
Studies evaluating the role of irisin in ankylosing spondylitis have reported lower serum irisin levels in patients with more severe disease manifestations. However, no studies investigating the effects of exercise therapy on serum irisin levels in patients with axial spondyloarthritis have been identified in the literature. Previous research has focused on the relationship between disease severity and serum irisin levels, as well as the association between serum irisin levels and cardiovascular disease in patients with ankylosing spondylitis. Overall, low serum irisin levels are thought to be indicative of subclinical atherosclerosis, increased cardiovascular risk, and more severe disease. Evaluating the relationship between serum irisin levels and exercise in patients with axial spondyloarthritis may provide important contributions to disease management and follow-up. Therefore, the present study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with axillary spondyloarthropathy according to ASAS diagnostic criteria,
- •Having a high disease severity (ASDAS-CRP above 2.1),
- •Being sedentary (not engaging in physical activity at least 3 days a week in the last 3 months),
- •Having no change in ankylosing spondylitis medical treatment in the last 3 months,
- •Not having any orthopedic, neurological, cardiovascular, or mental disease that would affect exercise,
- •Not using any assistive devices for ambulation,
- •Having a BMI of 25 kg/m2 or less,
- •Male and female patients aged 18-50 years.
排除标准
- •Those with uncontrolled cardiopulmonary disease (such as hypertension, chronic obstructive pulmonary disease, heart failure),
- •Having comorbidities that reduce exercise capacity,
- •Pregnancy,
- •Malignancy,
- •Those with a recent history of surgery,
- •Those who have engaged in regular exercise (aquatic exercise, land exercise, etc.) in the previous 3 months
研究组 & 干预措施
high-intensity exercise
Patients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend follow-up appointments regularly. Additionally, this group will undergo a high-intensity interval training (HIIT) program with a physiotherapist for 40 sessions in total, 5 sessions per week for 8 weeks, each lasting 35 minutes. Patients will work at 80% to 100% of their maximum heart rate. The first 4 weeks will be at 80% of maximum heart rate, followed by 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT, for a total exercise time of 35 minutes.
干预措施: High-Intensity Interval Training (Other)
moderate intensity exercise
Patients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend regular follow-up appointments. Additionally, these patients will undergo a 40-minute, 5-session, 40-minute moderate-intensity continuous exercise (MCIT) program with a physiotherapist over 8 weeks. Patients will exercise at 50-70% of their maximum heart rate and with an RPE of 11-13 for 30 minutes. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise duration of 40 minutes.
干预措施: Moderate-Intensity Continuous Exercise (Other)
control
Patients in this group will receive information and education about their illness and will be advised to continue their current medical treatment and attend their follow-up appointments regularly.
干预措施: control group (Other)
结局指标
主要结局
serum irisin level
时间窗: Before treatment and after treatment (week 8)
Blood samples will be taken from patients one day before the start of treatment, after a 12-hour fast, and again the morning after a 12-hour fast, immediately after the end of treatment. The collected blood samples will be centrifuged at 1500 g for 10 minutes to obtain serum. The obtained serum will be stored at -80°C until the day of the study. The aim of these serum samples is to determine the level of irisin.
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Before treatment, after treatment (week 8))
- Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP)(Before treatment, after treatment (week 8))
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Before treatment, after treatment (week 8))
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(Before treatment, after treatment (week 8))
- Ankylosing Spondylitis Quality of Life Scale (ASQoL)(Before treatment, after treatment (week 8))
研究者
Nazife Kapan
Asst. Prof.
Kirsehir Ahi Evran Universitesi