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

NCT05114343 | Unknown

• 1 other identifier: THE_JIA study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis; Juvenile Arthritis; Juvenile Rheumatoid Arthritis

Keywords

physical activity; exercise; vascular function; endothelial function; feasibility; home-based exercise

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• Left ventricular ejection fraction (LVEF)

  Left ventricular ejection fraction (LVEF) in percentage will be assessed using standard echocardiography.

  Change from baseline to 12 weeks

• 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

• 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

• 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

• Body fat

  Body fat in % will be assessed using dual-energy X-ray absorptiometry.

  Change from baseline to 12 weeks

• Lean mass

  Lean mass in kilograms will be assessed using dual-energy X-ray absorptiometry.

  Change from baseline to 12 weeks

• Bone mineral content

  Bone mineral content in grams will be assessed using dual-energy X-ray absorptiometry.

  Change from baseline to 12 weeks

• 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

• 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

• 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

• 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 Outcomes (23)

• Disease activity

  Change from baseline to 12 weeks

• Disease activity

  Change from baseline to 24 weeks

• Functional ability

  Change from baseline to 12 weeks

• Functional ability

  Change from baseline to 24 weeks

• Health-related quality of life

  Change from baseline to 12 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Usual care (control group)

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

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

Also known as: physical activity

Exercise group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tiago Peçanha, PhD

CONTACT

+5511948243542; tiagopecanha@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome (i.e., endothelial function) will be assessed by a blinded investigator.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 9, 2021
• Study Start: December 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: April 1, 2024
• Last Updated: November 9, 2021

Record last verified: 2021-08

Locations

BR (1)