Bariatric SurgeryNCT04425005
Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric
A study testing Home-based exercise in people with Bariatric Surgery and Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bariatric Surgery, Obesity
- What is being tested?
- Home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2020to 7 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women submitted to bariatric surgery in the last 12 months.
- Not engaged in regular exercise training programs.
Who cannot join
- Patients with >12 months of post-operatory period.
- Patients with diagnosed mental disorders.
- Patients with physical limitations or not allowed by the physician to exercise.
- Patients infected with Covid-19 at the time of data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial
The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
Read the detailed description
Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.
- Conditions
- Bariatric Surgery, Obesity
- Being tested
- Home-based exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseOther
Home-based exercise training, supervised by videoconference.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Exercise training group | Experimental | Not described Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on waist circumference at 3 months of follow-up.
Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration.
Measured: Baseline and 3 months
Secondary outcomes (5)
Change from baseline on cardiometabolic risk factor at 3 months of follow-up.
Cardiometabolic risk will be calculated using mean blood pressure, fasting triglycerides, HDL, waist circumference and fasting glucose. These outocomes will be presented separately as well.
Measured: Baseline and 3 months
Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
Cardiopulmonary fitness will be assessed by a validated two-minutes step test.
Measured: Baseline and 3 months
Change from baseline on quality of life at 3 months of follow up.
Will be evaluated by the SF-36 health survey questionnaire.
Measured: Baseline and 3 months
Change from baseline on Physical activity levels at 3 months of follow up.
Will be evaluated by the International Physical Activity Questionnaire.
Measured: Baseline and 3 months follow-up.
Change from baseline on dietary intake at 3 months of follow up.
Will be assessed by 24 hours food intake recall.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start10 May 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- 55 participants (actual)
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
- Investigators
- Bruno Gualano, Principal investigator, HC FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425005
- Sponsor's protocol ID
- 21056813.3.0000.0068
- Status last verified
- Jan 2021
- First submitted
- 8 Jun 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04425005
- Acronym / sponsor ID
- 21056813.3.0000.0068
- Conditions
- Bariatric Surgery, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 11 Jun 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.
The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
Detailed description
Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Exercise training group | Experimental | Other: Home-based exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women submitted to bariatric surgery in the last 12 months.
- Not engaged in regular exercise training programs.
Key exclusion criteria (4 listed)
- Patients with >12 months of post-operatory period.
- Patients with diagnosed mental disorders.
- Patients with physical limitations or not allowed by the physician to exercise.
- Patients infected with Covid-19 at the time of data collection.
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 |
|---|---|---|
| Home-based exerciseHome-based exercise training, supervised by videoconference. | Other | Exercise training group |
Primary outcome
Change from baseline on waist circumference at 3 months of follow-up.
Time frame: Baseline and 3 months
Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration.
5 secondary outcomes
Change from baseline on cardiometabolic risk factor at 3 months of follow-up.
Time frame: Baseline and 3 months
Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
Time frame: Baseline and 3 months
Change from baseline on quality of life at 3 months of follow up.
Time frame: Baseline and 3 months
Change from baseline on Physical activity levels at 3 months of follow up.
Time frame: Baseline and 3 months follow-up.
Change from baseline on dietary intake at 3 months of follow up.
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
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.
Bruno Gualano principal investigator
HC FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Bariatric Surgery and Obesity, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on waist circumference at 3 months of follow-up. (time frame: Baseline and 3 months). 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 22 Jan 2021.