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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458246
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Disease Chronic Diseases in Adolescence Chronic Disease of Immune System Chronic Kidney Diseases Other: Exercise training group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: 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.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and efficacy of a home-based exercise training program [ Time Frame: From baseline to 3 months of follow-up ]
    Semi structured interview


Secondary Outcome Measures :
  1. Patients perceptions during social isolation [ Time Frame: From baseline to 3 months of follow-up ]
    Semi structured interview

  2. Adolescents quality of life [ Time Frame: From baseline to 3 months of follow-up ]
    Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)

  3. Disease activity [ Time Frame: From baseline to 3 months of follow-up ]
    Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).

  4. Disease overall assessment [ Time Frame: From baseline to 3 months of follow-up ]
    Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).

  5. Strengths and difficulties [ Time Frame: From baseline to 3 months of follow-up ]
    Will be assessed by means of Strengths & Difficulties Questionnaires


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458246


Contacts
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Contact: Bruno Gualano, PhD +55 11 3061-8789 gualano@usp.br

Locations
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Brazil
Univsersity of Sao Paulo Recruiting
Sao Paulo, Brazil, 05508-030
Contact: Bruno Gualano, Phd    551130918783    gualano@usp.br   
Principal Investigator: Bruno Gualano, Phd         
Sponsors and Collaborators
University of Sao Paulo
More Information
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Responsible Party: Bruno Gualano, Dr, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04458246    
Other Study ID Numbers: 31314220.5.0000.0068
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Immune System Diseases
Chronic Disease
 Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes