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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-010
        • Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Exercise
Participants will perform weight-bearing exercises for 12 weeks. The intervention will be delivered remotely through video calling with an exercise specialist.
Other Names:
  • physical activity
No Intervention: Usual care (control group)
Participants in the control group will receive usual care and general instructions about physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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.
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.
Change from baseline to 12 weeks
Vascular structure
Time Frame: Change from baseline to 12 weeks
Vascular structure will be assessed through the analysis of common carotid intima-media thickness using a vascular ultrasound.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Change from baseline to 12 weeks
Disease activity
Time Frame: Change from baseline to 24 weeks
Participants' disease activity will be calculated using the Juvenile Arthritis Disease Activity Score.
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
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).
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
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
Physical activity and sedentary behavior
Time Frame: Change from baseline to 12 weeks
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Change from baseline to 12 weeks
Physical activity and sedentary behavior
Time Frame: Change from baseline to 24 weeks
Physical activity and sedentary behavior will be assessed using a thigh-worn accelerometer (activPAL).
Change from baseline to 24 weeks
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
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.
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
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
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
Functional capacity - Timed Up-And-Go
Time Frame: Change from baseline to 12 weeks
Functional capacity will be assessed busing the "Timed Up-And-Go" test and expressed in seconds.
Change from baseline to 12 weeks
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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