Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— THE_JIA  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05114343
• Other study ID #: THE_JIA study
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: April 2024

Study information

• Verified date: August 2021
• Source: University of Sao Paulo General Hospital
• Contact: Tiago Peçanha, PhD
• Phone: +5511948243542
• Email: tiagopecanha[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Arthritis
• Juvenile Idiopathic Arthritis
• Juvenile Rheumatoid Arthritis

Intervention

Behavioral:
• Exercise
Participants will perform weight-bearing exercises for 12 weeks. The intervention will be delivered remotely through video calling with an exercise specialist.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.	Change from baseline to 12 weeks
Primary	Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)	Left ventricle diastolic and systolic diameters, interventricular septum, and left ventricular posterior wall in millimeters per meter squared will be assessed using standard echocardiography.	Change from baseline to 12 weeks
Primary	Left ventricular ejection fraction (LVEF)	Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.	Change from baseline to 12 weeks
Primary	Left ventricular mass index	The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.	Change from baseline to 12 weeks
Primary	Left ventricular diastolic function	Left ventricular diastolic function will be assessed using tissue Doppler-based measurements of transmitral E and A velocities in metre per second.	Change from baseline to 12 weeks
Primary	Myocardial deformation	Myocardial deformation in longitudinal, radial, and circumferential directions will be assessed using two-dimensional speckle-tracking (2DST) echocardiography and expressed as a percentage.	Change from baseline to 12 weeks
Primary	Body fat	Body fat in % will be assessed using dual-energy X-ray absorptiometry.	Change from baseline to 12 weeks
Primary	Lean mass	Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.	Change from baseline to 12 weeks
Primary	Bone mineral content	Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.	Change from baseline to 12 weeks
Primary	Aerobic fitness	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.	Change from baseline to 12 weeks
Primary	Vascular structure	Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.	Change from baseline to 12 weeks
Primary	Feasibility of the intervention	Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.	Change from baseline to 12 weeks
Primary	Adherence to the intervention	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.	Change from baseline to 12 weeks
Secondary	Disease activity	Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.	Change from baseline to 12 weeks
Secondary	Disease activity	Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.	Change from baseline to 24 weeks
Secondary	Functional ability	The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).	Change from baseline to 12 weeks
Secondary	Functional ability	The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).	Change from baseline to 24 weeks
Secondary	Health-related quality of life	Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).	Change from baseline to 12 weeks
Secondary	Health-related quality of life	Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).	Change from baseline to 24 weeks
Secondary	Cardiometabolic blood markers	The following cardiometabolic markers from blood will be assessed after 12-h fasting: blood glucose and insulin, total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, and triglycerides. This data will be expressed in milligrams per deciliter.	Change from baseline to 12 weeks
Secondary	C-reactive protein	C-reactive protein levels in the blood will be assessed after 12-h fasting and expressed as milligrams per litre.	Change from baseline to 12 weeks
Secondary	Physical activity and sedentary behavior	Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).	Change from baseline to 12 weeks
Secondary	Physical activity and sedentary behavior	Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).	Change from baseline to 24 weeks
Secondary	Motivation to physical activity	Motivation to physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).	Change from baseline to 12 weeks
Secondary	Physical activity-related behavior	Physical activity-related behavior will be asseessed using the Stages of Change model.	Change from baseline to 12 weeks
Secondary	Food consumption	Food consumption will be assessed through 24-hour food recalls, collected on three non-consecutive days (one weekend day).	Change from baseline to 12 weeks
Secondary	Blood pressure	Blood pressure (arterial pressure) will be assessed non-invasively using a multi-parameter monitor.	Change from baseline to 12 weeks
Secondary	Cardiac autonomic function	Cardiac autonomic function will be assessed through the analysis of heart rate variability, which will be recorded using a heart rate monitor.	Change from baseline to 12 weeks
Secondary	Muscle strength	Muscle strength will be assessed by the one-repetition maximum test on the bench press and knee extension machines and will be expressed as kilograms.	Change from baseline to 12 weeks
Secondary	Muscle strength	Muscle strength will be assessed by the one-repetition maximum test on the bench press and knee extension machines and will be expressed as kilograms.	Change from baseline to 24 weeks
Secondary	Handgrip strength	Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.	Change from baseline to 12 weeks
Secondary	Handgrip strength	Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.	Change from baseline to 24 weeks
Secondary	Functional capacity - Timed-Stands	Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.	Change from baseline to 12 weeks
Secondary	Functional capacity - Timed-Stands	Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.	Change from baseline to 24 weeks
Secondary	Functional capacity - Timed Up-And-Go	Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.	Change from baseline to 12 weeks
Secondary	Functional capacity - Timed Up-And-Go	Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.	Change from baseline to 24 weeks