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

NCT04458246 | Unknown

• 1 other identifier: 31314220.5.0000.0068
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of a home-based exercise training program

  Semi structured interview

  From baseline to 3 months of follow-up

Secondary Outcomes (5)

• Patients perceptions during social isolation

  From baseline to 3 months of follow-up

• Adolescents quality of life

  From baseline to 3 months of follow-up

• Disease activity

  From baseline to 3 months of follow-up

• Disease overall assessment

  From baseline to 3 months of follow-up

• Strengths and difficulties

  From baseline to 3 months of follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO 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 be advised to maintain their daily routine.

Interventions

Exercise training group OTHER

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.

Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with physical limitations that preclude exercise.
• Patients diagnosed with COVID-19.
• Patients diagnosed with mental disorders.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

MeSH Terms

Conditions

Chronic Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Bruno Gualano, PhD

CONTACT

+55 11 3061-8789; gualano@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

BR (1)