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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458246
• Other study ID #: 31314220.5.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: +55 11 3061-8789
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease of Immune System
• Chronic Diseases in Adolescence
• Chronic Kidney Diseases
• Immune System Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Brazil	Univsersity of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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