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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Chronic Disease; Chronic Diseases in Adolescence; Chronic Disease of Immune System
• Intervention / Treatment: Other: Exercise training group

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Gualano, PhD; Phone Number: +55 11 3061-8789; Email: gualano@usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-030
    • Recruiting
    • Univsersity of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and efficacy of a home-based exercise training program	Semi structured interview	From baseline to 3 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients perceptions during social isolation	Semi structured interview	From baseline to 3 months of follow-up
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
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
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
Strengths and difficulties	Will be assessed by means of Strengths & Difficulties Questionnaires	From baseline to 3 months of follow-up

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; COVID-19; Kidney Diseases; Renal Insufficiency, Chronic; Chronic Disease; Immune System Diseases
• Other Study ID Numbers: 31314220.5.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No