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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04458246
Enrollment
140
Registered
2020-07-07
Start date
2020-07-31
Completion date
2021-06-30
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 19 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Safety and efficacy of a home-based exercise training programFrom baseline to 3 months of follow-upSemi structured interview

Secondary

MeasureTime frameDescription
Patients perceptions during social isolationFrom baseline to 3 months of follow-upSemi structured interview
Adolescents quality of lifeFrom baseline to 3 months of follow-upQuality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Disease activityFrom baseline to 3 months of follow-upWill be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Disease overall assessmentFrom baseline to 3 months of follow-upWill be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Strengths and difficultiesFrom baseline to 3 months of follow-upWill be assessed by means of Strengths & Difficulties Questionnaires

Countries

Brazil

Contacts

Primary ContactBruno Gualano, PhD
gualano@usp.br+55 11 3061-8789

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026