Effectiveness and Feasibility of a Technology-supported Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA Study): a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bone mineral content
研究概览
简要总结
This study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescents (< 18 years) with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Participants will be supported by educational materials, a heart rate monitor, and through periodic contact with an exercise specialist via video and phone calls, and text messages. The study's primary outcomes will be: cardiac and vascular function and structure using ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. In addition to that, the feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be assessed.
详细描述
Juvenile idiopathic arthritis (JIA) is the most common type of arthritis in children and adolescents under the age of 16. In addition to the articular features of the disease, JIA is also characterized by multiple comorbidities, including cardiovascular manifestations. Part of the health conditions observed in adolescents with JIA may be caused by a reduced practice of physical activity. Lack of physical activity in this disease has been attributed to generic and specific barriers, such as time constraints, low motivation, limited access to specialized exercise centers, lack of specific programs for JIA patients, among others. More recently, the COVID-19 pandemic has imposed additional challenges for the engagement in physical activity in populations with chronic disease, including patients with JIA. In this scenario, home-based exercise programs supported by technology have arisen as potentially effective alternatives to upregulate physical activity levels in adolescents with JIA, which needs to be further explored. Therefore, the aim of this study will be to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescent (< 18 years) patients with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages. Participants in the control group will receive usual care and general instructions about physical activity. The study's primary outcome will be the cardiac and vascular structure and function assessed by vascular ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. Secondary outcomes will include clinical aspects of the disease, blood parameters, physical activity and sedentary behavior, food consumption, health-related quality of life, blood pressure, and cardiac autonomic function. Feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be evaluated. The effects of the intervention on study outcomes will be assessed by a mixed model analysis (p < 0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Primary outcome (i.e., endothelial function) will be assessed by a blinded investigator.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with polyarticular or oligoarticular subtypes of juvenile idiopathic arthritis.
排除标准
- •Cardiovascular, metabolic, pulmonary or renal diseases
- •Untreat thyroid disease
- •Blood pressure > 140/80 mmHg
- •Use of statin
- •Use of tobacco
- •Any other disease or condition that may prevent the practice of physical activity
研究组 & 干预措施
Exercise group
Participants will be instructed to perform 3 sessions of weight-bearing exercise per week, for 12 weeks. Exercise intensity and duration will be low-to-moderate in the first 4 weeks, and will progressively increase during the program. Participants will be supported by educational materials, a heart rate monitor, and by means of periodic contact with an exercise specialist via video and phone calls, and text messages.
干预措施: Exercise (Behavioral)
Usual care (control group)
Participants in the control group will receive usual care and general instructions about physical activity.
结局指标
主要结局
Bone mineral content
时间窗: Change from baseline to 12 weeks
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
Endothelial function
时间窗: Change from baseline to 12 weeks
Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.
Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
时间窗: Change from baseline to 12 weeks
Left ventricle diastolic and systolic diameters, interventricular septum, and left ventricular posterior wall in millimeters per meter squared will be assessed using standard echocardiography.
Left ventricular ejection fraction (LVEF)
时间窗: Change from baseline to 12 weeks
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
Left ventricular mass index
时间窗: Change from baseline to 12 weeks
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
Body fat
时间窗: Change from baseline to 12 weeks
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
Left ventricular diastolic function
时间窗: Change from baseline to 12 weeks
Left ventricular diastolic function will be assessed using tissue Doppler-based measurements of transmitral E and A velocities in metre per second.
Myocardial deformation
时间窗: Change from baseline to 12 weeks
Myocardial deformation in longitudinal, radial, and circumferential directions will be assessed using two-dimensional speckle-tracking (2DST) echocardiography and expressed as a percentage.
Lean mass
时间窗: Change from baseline to 12 weeks
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
Vascular structure
时间窗: Change from baseline to 12 weeks
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Aerobic fitness
时间窗: Change from baseline to 12 weeks
Aerobic fitness will be assessed through a graded treadmill exercise test. VO2max will be assessed using a metabolic cart and expressed in millilitres per kilograms of body weight.
Adherence to the intervention
时间窗: Change from baseline to 12 weeks
The adherence to the intervention will be assessed using the data from the physical activity diaries and heart rate monitor and will be expressed as percentage of complete sessions.
Feasibility of the intervention
时间窗: Change from baseline to 12 weeks
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
次要结局
- C-reactive protein(Change from baseline to 12 weeks)
- Physical activity-related behavior(Change from baseline to 12 weeks)
- Blood pressure(Change from baseline to 12 weeks)
- Motivation to physical activity(Change from baseline to 12 weeks)
- Cardiac autonomic function(Change from baseline to 12 weeks)
- Functional capacity - Timed Up-And-Go(Change from baseline to 24 weeks)
- Functional ability(Change from baseline to 24 weeks)
- Health-related quality of life(Change from baseline to 24 weeks)
- Cardiometabolic blood markers(Change from baseline to 12 weeks)
- Disease activity(Change from baseline to 24 weeks)
- Handgrip strength(Change from baseline to 24 weeks)
- Physical activity and sedentary behavior(Change from baseline to 24 weeks)
- Food consumption(Change from baseline to 12 weeks)
- Muscle strength(Change from baseline to 24 weeks)
- Functional capacity - Timed-Stands(Change from baseline to 24 weeks)
- Disease activity(Change from baseline to 12 weeks)
- Functional ability(Change from baseline to 12 weeks)
- Health-related quality of life(Change from baseline to 12 weeks)
- Physical activity and sedentary behavior(Change from baseline to 12 weeks)
- Muscle strength(Change from baseline to 12 weeks)
- Handgrip strength(Change from baseline to 12 weeks)
- Functional capacity - Timed-Stands(Change from baseline to 12 weeks)
- Functional capacity - Timed Up-And-Go(Change from baseline to 12 weeks)