Clinical trial NCT05114343: Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis
Official title: Effectiveness and Feasibility of a Technology-supported Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA Study): a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Juvenile Arthritis
Juvenile Rheumatoid Arthritis
Keywords: physical activity
exercise
vascular function
endothelial function
feasibility
home-based exercise
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients with polyarticular or oligoarticular subtypes of juvenile idiopathic arthritis.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Endothelial function
timeFrame: Change from baseline to 12 weeks
measure: Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
timeFrame: Change from baseline to 12 weeks
measure: Left ventricular ejection fraction (LVEF)
timeFrame: Change from baseline to 12 weeks
measure: Left ventricular mass index
timeFrame: Change from baseline to 12 weeks
measure: Left ventricular diastolic function
timeFrame: Change from baseline to 12 weeks
measure: Myocardial deformation
timeFrame: Change from baseline to 12 weeks
measure: Body fat
timeFrame: Change from baseline to 12 weeks
measure: Lean mass
timeFrame: Change from baseline to 12 weeks
measure: Bone mineral content
timeFrame: Change from baseline to 12 weeks
measure: Aerobic fitness
timeFrame: Change from baseline to 12 weeks
measure: Vascular structure
timeFrame: Change from baseline to 12 weeks
measure: Feasibility of the intervention
timeFrame: Change from baseline to 12 weeks
measure: Adherence to the intervention
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Disease activity
timeFrame: Change from baseline to 12 weeks
measure: Disease activity
timeFrame: Change from baseline to 24 weeks
measure: Functional ability
timeFrame: Change from baseline to 12 weeks
measure: Functional ability
timeFrame: Change from baseline to 24 weeks
measure: Health-related quality of life
timeFrame: Change from baseline to 12 weeks
measure: Health-related quality of life
timeFrame: Change from baseline to 24 weeks
measure: Cardiometabolic blood markers
timeFrame: Change from baseline to 12 weeks
measure: C-reactive protein
timeFrame: Change from baseline to 12 weeks
measure: Physical activity and sedentary behavior
timeFrame: Change from baseline to 12 weeks
measure: Physical activity and sedentary behavior
timeFrame: Change from baseline to 24 weeks
measure: Motivation to physical activity
timeFrame: Change from baseline to 12 weeks
measure: Physical activity-related behavior
timeFrame: Change from baseline to 12 weeks
measure: Food consumption
timeFrame: Change from baseline to 12 weeks
measure: Blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Cardiac autonomic function
timeFrame: Change from baseline to 12 weeks
measure: Muscle strength
timeFrame: Change from baseline to 12 weeks
measure: Muscle strength
timeFrame: Change from baseline to 24 weeks
measure: Handgrip strength
timeFrame: Change from baseline to 12 weeks
measure: Handgrip strength
timeFrame: Change from baseline to 24 weeks
measure: Functional capacity - Timed-Stands
timeFrame: Change from baseline to 12 weeks
measure: Functional capacity - Timed-Stands
timeFrame: Change from baseline to 24 weeks
measure: Functional capacity - Timed Up-And-Go
timeFrame: Change from baseline to 12 weeks
measure: Functional capacity - Timed Up-And-Go
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
Study officials:
References: