Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic
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ClinicalTrials.gov Identifier: NCT04458246 |
Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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Chronic Disease Chronic Diseases in Adolescence Chronic Disease of Immune System Chronic Kidney Diseases | Other: Exercise training group | Not Applicable |
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 |

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.
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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.
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- Safety and efficacy of a home-based exercise training program [ Time Frame: From baseline to 3 months of follow-up ]Semi structured interview
- Patients perceptions during social isolation [ Time Frame: From baseline to 3 months of follow-up ]Semi structured interview
- 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)
- 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).
- 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).
- Strengths and difficulties [ Time Frame: From baseline to 3 months of follow-up ]Will be assessed by means of Strengths & Difficulties Questionnaires

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Ages Eligible for Study: | 10 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Bruno Gualano, PhD | +55 11 3061-8789 | gualano@usp.br |
Brazil | |
Univsersity of Sao Paulo | Recruiting |
Sao Paulo, Brazil, 05508-030 | |
Contact: Bruno Gualano, Phd 551130918783 gualano@usp.br | |
Principal Investigator: Bruno Gualano, Phd |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Kidney Diseases Renal Insufficiency, Chronic Immune System Diseases Chronic Disease Urologic Diseases Renal Insufficiency Respiratory Tract Infections Infections Pneumonia, Viral |
Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Disease Attributes Pathologic Processes |