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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univsersity of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety and efficacy of a home-based exercise training program
Semi structured interview

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2020
Last Updated
July 2, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04458246
Brief Title
Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic
Official Title
Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Chronic Diseases in Adolescence, Chronic Disease of Immune System, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and efficacy of a home-based exercise training program
Description
Semi structured interview
Time Frame
From baseline to 3 months of follow-up
Secondary Outcome Measure Information:
Title
Patients perceptions during social isolation
Description
Semi structured interview
Time Frame
From baseline to 3 months of follow-up
Title
Adolescents quality of life
Description
Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Time Frame
From baseline to 3 months of follow-up
Title
Disease activity
Description
Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Time Frame
From baseline to 3 months of follow-up
Title
Disease overall assessment
Description
Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Time Frame
From baseline to 3 months of follow-up
Title
Strengths and difficulties
Description
Will be assessed by means of Strengths & Difficulties Questionnaires
Time Frame
From baseline to 3 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Gualano, PhD
Phone
+55 11 3061-8789
Email
gualano@usp.br
Facility Information:
Facility Name
Univsersity of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, Phd
Phone
551130918783
Email
gualano@usp.br
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, Phd

12. IPD Sharing Statement

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

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