Chronic DiseaseNCT04458246
Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic
A study testing Exercise training group in people with Chronic Disease and Chronic Diseases in Adolescence, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Chronic Disease, Chronic Diseases in Adolescence, Chronic Disease of Immune System
- What is being tested?
- Exercise training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients with physical limitations that preclude exercise.
- Patients diagnosed with COVID-19.
- Patients diagnosed with mental disorders.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Univsersity of Sao Paulo
São Paulo, 05508-030
Bruno Gualano, Phd, 551130918783, gualano@usp.br
Bruno Gualano, Phd
About this study
Official title: 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.
- Conditions
- Chronic Disease, Chronic Diseases in Adolescence, Chronic Disease of Immune System, Chronic Kidney Diseases
- Being tested
- Exercise training group
- Medical subject headings
- Chronic Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of a home-based exercise training program
Semi structured interview
Measured: From baseline to 3 months of follow-up
Secondary outcomes (5)
Patients perceptions during social isolation
Semi structured interview
Measured: 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)
Measured: 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).
Measured: 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).
Measured: From baseline to 3 months of follow-up
Strengths and difficulties
Will be assessed by means of Strengths \& Difficulties Questionnaires
Measured: From baseline to 3 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458246
- Sponsor's protocol ID
- 31314220.5.0000.0068
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04458246
- Acronym / sponsor ID
- 31314220.5.0000.0068
- Conditions
- Chronic Disease, Chronic Diseases in Adolescence, Chronic Disease of Immune System, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise training group10 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. |
| 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Inflammatory bowel disease;
- autoimmune hepatitis;
- liver transplant;
- renal transplant;
- systemic lupus erythematosus;
Key exclusion criteria (3 listed)
- Patients with physical limitations that preclude exercise.
- Patients diagnosed with COVID-19.
- Patients diagnosed with mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training groupOnline 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. | Other | Intervention |
Primary outcome
Safety and efficacy of a home-based exercise training program
Time frame: From baseline to 3 months of follow-up
Semi structured interview
5 secondary outcomes
Patients perceptions during social isolation
Time frame: From baseline to 3 months of follow-up
Adolescents quality of life
Time frame: From baseline to 3 months of follow-up
Disease activity
Time frame: From baseline to 3 months of follow-up
Disease overall assessment
Time frame: From baseline to 3 months of follow-up
Strengths and difficulties
Time frame: From baseline to 3 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training group in people with Chronic Disease and Chronic Diseases in Adolescence, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (+55 11 3061-8789, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of a home-based exercise training program (time frame: From baseline to 3 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.