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

NCT ID: NCT04458246

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-06-30

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Exercise training group

Intervention Type OTHER

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training group

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.

Intervention Type OTHER

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Univsersity of Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruno Gualano, PhD

Role: CONTACT

+55 11 3061-8789

Facility Contacts

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Bruno Gualano, Phd

Role: primary

551130918783

Other Identifiers

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31314220.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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