- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114343
Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA)
October 28, 2021 updated by: University of Sao Paulo General Hospital
Effectiveness and Feasibility of a Technology-supported Home-based Exercise Program for Adolescents With Juvenile Idiopathic Arthritis (THE_JIA Study): a Randomized Controlled Trial.
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tiago Peçanha, PhD
- Phone Number: +5511948243542
- Email: tiagopecanha@usp.br
Study Locations
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-
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Sao Paulo, Brazil, 05403-010
- Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will perform weight-bearing exercises for 12 weeks.
The intervention will be delivered remotely through video calling with an exercise specialist.
Other Names:
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No Intervention: Usual care (control group)
Participants in the control group will receive usual care and general instructions about physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial function
Time Frame: Change from baseline to 12 weeks
|
Endothelial function will be assessed through the evaluation of brachial flow-mediated dilation using a vascular ultrasound.
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Change from baseline to 12 weeks
|
Cardiac chamber dimensions (left ventricle diastolic and systolic diameters, interventricular septum, left ventricular posterior wall)
Time Frame: 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.
|
Change from baseline to 12 weeks
|
Left ventricular ejection fraction (LVEF)
Time Frame: Change from baseline to 12 weeks
|
Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.
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Change from baseline to 12 weeks
|
Left ventricular mass index
Time Frame: Change from baseline to 12 weeks
|
The left ventricular mass index in grams per body surface area will be assessed using standard echocardiography.
|
Change from baseline to 12 weeks
|
Left ventricular diastolic function
Time Frame: 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.
|
Change from baseline to 12 weeks
|
Myocardial deformation
Time Frame: 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.
|
Change from baseline to 12 weeks
|
Body fat
Time Frame: Change from baseline to 12 weeks
|
Body fat in % will be assessed using dual-energy X-ray absorptiometry.
|
Change from baseline to 12 weeks
|
Lean mass
Time Frame: Change from baseline to 12 weeks
|
Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.
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Change from baseline to 12 weeks
|
Bone mineral content
Time Frame: Change from baseline to 12 weeks
|
Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.
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Change from baseline to 12 weeks
|
Aerobic fitness
Time Frame: 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.
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Change from baseline to 12 weeks
|
Vascular structure
Time Frame: Change from baseline to 12 weeks
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Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
|
Change from baseline to 12 weeks
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Feasibility of the intervention
Time Frame: Change from baseline to 12 weeks
|
Feasibility of the intervention will be assessed through interviews investigating the experiences of the participants during the intervention.
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Change from baseline to 12 weeks
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Adherence to the intervention
Time Frame: 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.
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Change from baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease activity
Time Frame: Change from baseline to 12 weeks
|
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
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Change from baseline to 12 weeks
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Disease activity
Time Frame: Change from baseline to 24 weeks
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Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
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Change from baseline to 24 weeks
|
Functional ability
Time Frame: Change from baseline to 12 weeks
|
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
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Functional ability
Time Frame: Change from baseline to 24 weeks
|
The functional ability of the participants with JIA will be assessed through the Brazilian-Portuguese version of the Childhood Health Assessment Questionnaire (CHAQ).
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Change from baseline to 24 weeks
|
Health-related quality of life
Time Frame: Change from baseline to 12 weeks
|
Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
|
Change from baseline to 12 weeks
|
Health-related quality of life
Time Frame: Change from baseline to 24 weeks
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Health-related quality of life will be assessed through the Pediatric Quality of Life Inventory (PedsQL).
|
Change from baseline to 24 weeks
|
Cardiometabolic blood markers
Time Frame: Change from baseline to 12 weeks
|
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.
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Change from baseline to 12 weeks
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C-reactive protein
Time Frame: Change from baseline to 12 weeks
|
C-reactive protein levels in the blood will be assessed after 12-h fasting and expressed as milligrams per litre.
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Change from baseline to 12 weeks
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Physical activity and sedentary behavior
Time Frame: Change from baseline to 12 weeks
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Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
|
Change from baseline to 12 weeks
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Physical activity and sedentary behavior
Time Frame: Change from baseline to 24 weeks
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Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
|
Change from baseline to 24 weeks
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Motivation to physical activity
Time Frame: Change from baseline to 12 weeks
|
Motivation to physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).
|
Change from baseline to 12 weeks
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Physical activity-related behavior
Time Frame: Change from baseline to 12 weeks
|
Physical activity-related behavior will be asseessed using the Stages of Change model.
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Change from baseline to 12 weeks
|
Food consumption
Time Frame: Change from baseline to 12 weeks
|
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
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Blood pressure
Time Frame: Change from baseline to 12 weeks
|
Blood pressure (arterial pressure) will be assessed non-invasively using a multi-parameter monitor.
|
Change from baseline to 12 weeks
|
Cardiac autonomic function
Time Frame: Change from baseline to 12 weeks
|
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
|
Muscle strength
Time Frame: Change from baseline to 12 weeks
|
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
|
Muscle strength
Time Frame: Change from baseline to 24 weeks
|
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
|
Handgrip strength
Time Frame: Change from baseline to 12 weeks
|
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
|
Change from baseline to 12 weeks
|
Handgrip strength
Time Frame: Change from baseline to 24 weeks
|
Handgrip strength will be assessed using handgrip dynamometry and expressed as kilograms.
|
Change from baseline to 24 weeks
|
Functional capacity - Timed-Stands
Time Frame: Change from baseline to 12 weeks
|
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
|
Functional capacity - Timed-Stands
Time Frame: Change from baseline to 24 weeks
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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
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Functional capacity - Timed Up-And-Go
Time Frame: Change from baseline to 12 weeks
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Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
|
Change from baseline to 12 weeks
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Functional capacity - Timed Up-And-Go
Time Frame: Change from baseline to 24 weeks
|
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
|
Change from baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
April 1, 2024
Study Registration Dates
First Submitted
October 7, 2021
First Submitted That Met QC Criteria
October 28, 2021
First Posted (Actual)
November 9, 2021
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
October 28, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THE_JIA study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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