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

Primary Purpose

Juvenile Idiopathic Arthritis, Juvenile Arthritis, Juvenile Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Juvenile Idiopathic Arthritis focused on measuring physical activity, exercise, vascular function, endothelial function, feasibility, home-based exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Usual care (control group)

Arm Description

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.

Participants in the control group will receive usual care and general instructions about physical activity.

Outcomes

Primary Outcome Measures

Endothelial function
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)
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)
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
Left ventricular mass index
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
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.
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.
Body fat
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
Lean mass
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
Bone mineral content
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
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.
Vascular structure
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Feasibility of the intervention
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
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.

Secondary Outcome Measures

Disease activity
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
Disease activity
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
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).
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).
Health-related quality of life
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
Health-related quality of life
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
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.
C-reactive protein
C-reactive protein levels in the blood will be assessed after 12-h fasting and expressed as milligrams per litre.
Physical activity and sedentary behavior
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Physical activity and sedentary behavior
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Motivation to physical activity
Motivation to physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).
Physical activity-related behavior
Physical activity-related behavior will be asseessed using the Stages of Change model.
Food consumption
Food consumption will be assessed through 24-hour food recalls, collected on three non-consecutive days (one weekend day).
Blood pressure
Blood pressure (arterial pressure) will be assessed non-invasively using a multi-parameter monitor.
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.
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.
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.
Handgrip strength
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Handgrip strength
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Functional capacity - Timed-Stands
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Functional capacity - Timed-Stands
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Functional capacity - Timed Up-And-Go
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Functional capacity - Timed Up-And-Go
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.

Full Information

First Posted
October 7, 2021
Last Updated
October 28, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05114343
Brief Title
Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis, Juvenile Arthritis, Juvenile Rheumatoid Arthritis
Keywords
physical activity, exercise, vascular function, endothelial function, feasibility, home-based exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary outcome (i.e., endothelial function) will be assessed by a blinded investigator.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care (control group)
Arm Type
No Intervention
Arm Description
Participants in the control group will receive usual care and general instructions about physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
physical activity
Intervention Description
Participants will perform weight-bearing exercises for 12 weeks. The intervention will be delivered remotely through video calling with an exercise specialist.
Primary Outcome Measure Information:
Title
Endothelial function
Description
Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.
Time Frame
Change from baseline to 12 weeks
Title
Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
Description
Left ventricle diastolic and systolic diameters, interventricular septum, and left ventricular posterior wall in millimeters per meter squared will be assessed using standard echocardiography.
Time Frame
Change from baseline to 12 weeks
Title
Left ventricular ejection fraction (LVEF)
Description
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
Time Frame
Change from baseline to 12 weeks
Title
Left ventricular mass index
Description
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
Time Frame
Change from baseline to 12 weeks
Title
Left ventricular diastolic function
Description
Left ventricular diastolic function will be assessed using tissue Doppler-based measurements of transmitral E and A velocities in metre per second.
Time Frame
Change from baseline to 12 weeks
Title
Myocardial deformation
Description
Myocardial deformation in longitudinal, radial, and circumferential directions will be assessed using two-dimensional speckle-tracking (2DST) echocardiography and expressed as a percentage.
Time Frame
Change from baseline to 12 weeks
Title
Body fat
Description
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
Time Frame
Change from baseline to 12 weeks
Title
Lean mass
Description
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
Time Frame
Change from baseline to 12 weeks
Title
Bone mineral content
Description
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
Time Frame
Change from baseline to 12 weeks
Title
Aerobic fitness
Description
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.
Time Frame
Change from baseline to 12 weeks
Title
Vascular structure
Description
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Time Frame
Change from baseline to 12 weeks
Title
Feasibility of the intervention
Description
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
Time Frame
Change from baseline to 12 weeks
Title
Adherence to the intervention
Description
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.
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Disease activity
Description
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
Time Frame
Change from baseline to 12 weeks
Title
Disease activity
Description
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
Time Frame
Change from baseline to 24 weeks
Title
Functional ability
Description
The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).
Time Frame
Change from baseline to 12 weeks
Title
Functional ability
Description
The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).
Time Frame
Change from baseline to 24 weeks
Title
Health-related quality of life
Description
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
Time Frame
Change from baseline to 12 weeks
Title
Health-related quality of life
Description
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
Time Frame
Change from baseline to 24 weeks
Title
Cardiometabolic blood markers
Description
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.
Time Frame
Change from baseline to 12 weeks
Title
C-reactive protein
Description
C-reactive protein levels in the blood will be assessed after 12-h fasting and expressed as milligrams per litre.
Time Frame
Change from baseline to 12 weeks
Title
Physical activity and sedentary behavior
Description
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Time Frame
Change from baseline to 12 weeks
Title
Physical activity and sedentary behavior
Description
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Time Frame
Change from baseline to 24 weeks
Title
Motivation to physical activity
Description
Motivation to physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).
Time Frame
Change from baseline to 12 weeks
Title
Physical activity-related behavior
Description
Physical activity-related behavior will be asseessed using the Stages of Change model.
Time Frame
Change from baseline to 12 weeks
Title
Food consumption
Description
Food consumption will be assessed through 24-hour food recalls, collected on three non-consecutive days (one weekend day).
Time Frame
Change from baseline to 12 weeks
Title
Blood pressure
Description
Blood pressure (arterial pressure) will be assessed non-invasively using a multi-parameter monitor.
Time Frame
Change from baseline to 12 weeks
Title
Cardiac autonomic function
Description
Cardiac autonomic function will be assessed through the analysis of heart rate variability, which will be recorded using a heart rate monitor.
Time Frame
Change from baseline to 12 weeks
Title
Muscle strength
Description
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.
Time Frame
Change from baseline to 12 weeks
Title
Muscle strength
Description
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.
Time Frame
Change from baseline to 24 weeks
Title
Handgrip strength
Description
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Time Frame
Change from baseline to 12 weeks
Title
Handgrip strength
Description
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
Time Frame
Change from baseline to 24 weeks
Title
Functional capacity - Timed-Stands
Description
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Time Frame
Change from baseline to 12 weeks
Title
Functional capacity - Timed-Stands
Description
Functional capacity will be assessed using the "Timed-Stands" test and expressed by the number of sit-to-stand repetitions.
Time Frame
Change from baseline to 24 weeks
Title
Functional capacity - Timed Up-And-Go
Description
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Time Frame
Change from baseline to 12 weeks
Title
Functional capacity - Timed Up-And-Go
Description
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Time Frame
Change from baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiago Peçanha, PhD
Phone
+5511948243542
Email
tiagopecanha@usp.br
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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

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