Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic

Study Overview
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Brief Summary
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Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.

Official Title
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Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial

Conditions
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Chronic Disease, Chronic Diseases in Adolescence, Chronic Disease of Immune System, Chronic Kidney Diseases

Intervention / Treatment
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* Other: Exercise training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with either one of the following chronic conditions: Inflammatory bowel disease; autoimmune hepatitis; liver transplant; renal transplant; systemic lupus erythematosus; juvenile dermatomyositis; juvenile idiopathic arthritis. Exclusion Criteria: Patients with physical limitations that preclude exercise. Patients diagnosed with COVID-19. Patients diagnosed with mental disorders.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will receive an online home-based aerobic training, three times a week, during 3 months. | Other: Exercise training group<br>* Online aerobic home-based exercise training, 3 times per week, during 3 months. The exercise program is composed by 3 levels (starter, intermediate and advanced) which be completed in the first, second and third month of intervention, respectively.<br>|
| No Intervention: Control<br>10 patients from each chronic diseases conditions (1- Inflammatory bowel disease; 2- autoimmune hepatitis; 3- liver transplant; 4- renal transplant; 5- systemic lupus erythematosus; 6- juvenile dermatomyositis; 7- juvenile idiopathic arthritis) will be advised to maintain their daily routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of a home-based exercise training program | Semi structured interview | From baseline to 3 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients perceptions during social isolation | Semi structured interview | From baseline to 3 months of follow-up | 
| Adolescents quality of life | Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0) | From baseline to 3 months of follow-up | 
| Disease activity | Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity). | From baseline to 3 months of follow-up | 
| Disease overall assessment | Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition). | From baseline to 3 months of follow-up | 
| Strengths and difficulties | Will be assessed by means of Strengths & Difficulties Questionnaires | From baseline to 3 months of follow-up |