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

Not Applicable

• Conditions: Chronic Kidney Diseases; Chronic Disease; Chronic Disease of Immune System; Chronic Diseases in Adolescence
• Interventions: Other: Exercise training group

• Registration Number: NCT04458246
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exercise training group	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.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of a home-based exercise training program	From baseline to 3 months of follow-up	Semi structured interview

Secondary Outcome Measures

Name	Time	Method
Patients perceptions during social isolation	From baseline to 3 months of follow-up	Semi structured interview
Adolescents quality of life	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	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	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	From baseline to 3 months of follow-up	Will be assessed by means of Strengths \& Difficulties Questionnaires

Trial Locations

Locations (1)

Univsersity of Sao Paulo; 🇧🇷 Sao Paulo, Brazil