Sedentary BehaviorREMOVENCT04153214
Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk (REMOVE)
A study testing cycling in people with Sedentary Behavior, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The recent literature has highlighting the importance of the time of inactivity and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to Jan 2022
- 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 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy volunteer, male or female, between 18 and 61 years old
- Body mass index > 18,5 kg/m2 and ≤ 35 kg/m2
- More than 0.8 full time equivalent hours (FTE) with 75% of this time in a sitting position
- Able to provide informed consent to research participation
- Registered in the French social security system
Who cannot join
- Work involving multiple periods of sitting interruptions >1 minute
- Subject using a sit-to-stand office desk or a swiss ball
- Sports activity > 2.5 hours/week
- Contact jobs (face-to-face with people)
- Pregnant or breastfeeding women
- Medical or surgical history determined by principal investigator to be not compatible with the study
Show all 22Show fewer
- Subject with cardiorespiratory and/or osteo-articular disorders limiting their ability to perform physical tests or the use of active offices
- Subject with type 1 or type 2 diabetes treated with insulin
- Subject with progressive cardiovascular or neoplastic disease.
- Subject with a major infection within 3 months of inclusion.
- Subject with known neuromuscular pathology: myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia
- Subject with chronic or acute inflammatory pathology 3 months prior to inclusion
- Subject treated by beta-blocker
- Subject diagnosed and/or treated for schizophrenia, bipolar disorders, major depression
- Subject treated, or having stopped treatment for less than 3 months prior to inclusion, by corticosteroids, immunosuppressant, anabolic, growth hormone.
- Subject with unstable psychiatric condition
- Significant alcohol consumption (> 2-3 drinks per day depending on gender) or presence of substance abuse.
- Unable to walk or pedal 45 minutes in a row
- Subject who is excluded from another study or who received more than €4,500 in the year following his participation in clinical studies
- Subject deprived of their liberty by judicial or administrative decision
- Refusal to sign written consent to participate
- Subject participating in another study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Martine Duclos, 0473751664, mduclos@chu-clermontferrand.fr
Martine Duclos
About this study
Official title: Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk
The recent literature has highlighting the importance of the time of inactivity and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. As with physical activity, a dose-response relationship appears to exist: mortality would increase with time spent in sedentary behaviors. However, this relationship would not be linear: the more the daily sitting time increases, the more the consequences on mortality are important. It is now well demonstrated that time spent in sedentary adult behaviour finds primarily its origin in the work, characterized by prolonged and uninterrupted periods of sitting. Many strategies have been settled to break the prolonged sitting time. The most promising one seem to be the use of active workstations (treadmill, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. If active workstations have demonstrated their effectiveness with overweight or obese people by increasing daily energy expenditure, their interest in prevention in normal weight people is less known. In addition, the long-term effectiveness of a program of reactivation by active workstation on biological parameters, quantitative and qualitative time of sedentary behaviour (duration, number of breaks) and physical fitness was not assessed.
The main objective of this project is to study the effects of the use of a cycling workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time.
Read the detailed description
Subject will have a pre-inclusion visit during a medical consultation where the eligibility criteria to participate to this study will be checked.
After the inclusion of subject and their agreements to participate to the study, they will know in which group they are :
- Group who performs 30minutes twice a working day from day 1 to day 180 (interventional)
- Group who performs 30minutes twice a working day from day 90 to day 180 (control)
They will have evaluation at three different times : T0 (Day 1), T1 (Day 90), T2 (Day 180). The evaluation will evaluate :
- overall quantity and quality of physical activity time (work and non-work) and sedentary time
- Body composition
- Biological parameters
- Physical fitness
- Psychological parameters At the end of the protocol, there will be an assessment of the obstacles or motivations to this program.
- Conditions
- Sedentary Behavior
- Being tested
- cycling
- Keywords
- Cardiometabolic health, Sedentary Behavior, Active workstation, Cycling desk
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclingBehavioural
Participants will have a portable pedal machine under their desk and will use it 60minutes per day
| Study group | Role | What they receive |
|---|---|---|
| Cycling workstation | Experimental | Participants will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 6 months Receives: Behavioral: cycling |
| control | Placebo comparator | Daily activities unchanged during 3 months. Then they will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 3 months. Receives: Behavioral: cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of the use of a cycling Workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time
Quantify by the use of an accelerometer device wears at the hip
Measured: month 3
Secondary outcomes (36)
Body composition
Body fat mass, body fat free mass will be assessed by bioimpedance analysis
Measured: day 90
Body composition
Body fat mass, body fat free mass will be assessed by bioimpedance analysis
Measured: day 180
Body composition
Body fat mass, body fat free mass will be assessed by bioimpedance analysis
Measured: day 1
Biological parameters - insulin
will be assessed in the fasting state using blood sample (insulin mlUI/L)
Measured: Day 1
Biological parameters - insulin
will be assessed in the fasting state using blood sample (insulin mlUI/L)
Measured: Day 90
Biological parameters - insulin
will be assessed in the fasting state using blood sample (insulin mlUI/L)
Measured: Day 180
Biological parameters - glucose
will be assessed in the fasting state using blood sample (glucose g/L)
Measured: Day 1
Biological parameters - glucose
will be assessed in the fasting state using blood sample (glucose g/L)
Measured: Day 90
Biological parameters - glucose
will be assessed in the fasting state using blood sample (glucose g/L)
Measured: Day 180
Biological parameters - triglycerides
will be assessed in the fasting state using blood sample (triglycerides g/L)
Measured: Day 1
Biological parameters - triglycerides
will be assessed in the fasting state using blood sample (triglycerides g/L)
Measured: Day 90
Biological parameters - triglycerides
will be assessed in the fasting state using blood sample (triglycerides g/L)
Measured: Day 180
Biological parameters - cholesterol
will be assessed in the fasting state using blood sample (cholesterol g/L)
Measured: Day 1
Biological parameters - cholesterol
will be assessed in the fasting state using blood sample (cholesterol g/L)
Measured: Day 90
Biological parameters - cholesterol
will be assessed in the fasting state using blood sample (cholesterol g/L)
Measured: Day 180
Biological parameters - CRP
will be assessed in the fasting state using blood sample (CRP-us mg/L)
Measured: Day 1
Biological parameters - CRP
will be assessed in the fasting state using blood sample (CRP-us mg/L)
Measured: Day 90
Biological parameters - CRP
will be assessed in the fasting state using blood sample (CRP-us mg/L)
Measured: Day 180
Biological parameters - anandamide
will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)
Measured: Day 1
Biological parameters - anandamide
will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)
Measured: Day 90
Biological parameters - anandamide
will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)
Measured: Day 180
Psychological assessment
Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)
Measured: Day 1
Psychological assessment
Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)
Measured: Day 90
Psychological assessment
Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)
Measured: Day 180
Resting metabolic rate
will be assessed at rest during 30 minutes using indirect calorimetry
Measured: Day 1
Resting metabolic rate
will be assessed at rest during 30 minutes using indirect calorimetry
Measured: Day 90
Resting metabolic rate
will be assessed at rest during 30 minutes using indirect calorimetry
Measured: Day 180
Physical capacity
will be assessed with the Step Test 6 minutes
Measured: Day 1
Physical capacity
will be assessed with the Step Test 6 minutes
Measured: Day 90
Physical capacity
will be assessed with the Step Test 6 minutes
Measured: Day 180
Muscle Strength
will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle
Measured: Day 1
Muscle Strength
will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle
Measured: Day 90
Muscle Strength
will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle
Measured: Day 180
Quality of the time spend to physical activities and sedentary behaviour
- moderate and high intensity physical activity
- low intensity physical activity
- total sedentary time
- number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip
Measured: Day 1
Quality of the time spend to physical activities and sedentary behaviour
- moderate and high intensity physical activity
- low intensity physical activity
- total sedentary time
- number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip
Measured: Day 90
Quality of the time spend to physical activities and sedentary behaviour
- moderate and high intensity physical activity
- low intensity physical activity
- total sedentary time
- number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start6 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153214
- Sponsor's protocol ID
- RBHP 2019 DUCLOS 2
- Other IDs
- 2019-A04449-48
- Acronym
- REMOVE
- Status last verified
- Jan 2020
- First submitted
- 4 Nov 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nasir H, Dutheil F, Ramos I, Guirado T, de Saint-Vincent S, Thivel D, Metz L, Duclos M. Effects of portable pedal machines at work on lipoprotein subfraction profile in sedentary workers - the REMOVE study. Lipids Health Dis. 2024 Apr 14;23(1):105. doi: 10.1186/s12944-024-02098-w.
PubMed 38616275Guirado T, Metz L, Pereira B, Brun C, Birat A, Boscaro A, Bergouignan A, Thivel D, Duclos M. A 12-Week Cycling Workstation Intervention Improves Cardiometabolic Risk Factors in Healthy Inactive Office Workers. J Occup Environ Med. 2022 Aug 1;64(8):e467-e474. doi: 10.1097/JOM.0000000000002583. Epub 2022 Jun 11.
PubMed 35673701Guirado T, Metz L, Pereira B, Bergouignan A, Thivel D, Duclos M. Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial. Trials. 2021 May 22;22(1):359. doi: 10.1186/s13063-021-05317-2.
PubMed 34022938
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk
- ClinicalTrials.gov ID
- NCT04153214
- Acronym / sponsor ID
- REMOVE / RBHP 2019 DUCLOS 2
- Conditions
- Sedentary Behavior
- Keywords
- Cardiometabolic health, Sedentary Behavior, Active workstation, Cycling desk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 6 Nov 2019 (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 recent literature has highlighting the importance of the time of inactivity and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. As with physical activity, a dose-response relationship appears to exist: mortality would increase with time spent in sedentary behaviors. However, this relationship would not be linear: the more the daily sitting time increases, the more the consequences on mortality are important. It is now well demonstrated that time spent in sedentary adult behaviour finds primarily its origin in the work, characterized by prolonged and uninterrupted periods of sitting. Many strategies have been settled to break the prolonged sitting time. The most promising one seem to be the use of active workstations (treadmill, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. If active workstations have demonstrated their effectiveness with overweight or obese people by increasing daily energy expenditure, their interest in prevention in normal weight people is less known. In addition, the long-term effectiveness of a program of reactivation by active workstation on biological parameters, quantitative and qualitative time of sedentary behaviour (duration, number of breaks) and physical fitness was not assessed.
The main objective of this project is to study the effects of the use of a cycling workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time.
Detailed description
Subject will have a pre-inclusion visit during a medical consultation where the eligibility criteria to participate to this study will be checked.
After the inclusion of subject and their agreements to participate to the study, they will know in which group they are :
- Group who performs 30minutes twice a working day from day 1 to day 180 (interventional)
- Group who performs 30minutes twice a working day from day 90 to day 180 (control)
They will have evaluation at three different times : T0 (Day 1), T1 (Day 90), T2 (Day 180). The evaluation will evaluate :
- overall quantity and quality of physical activity time (work and non-work) and sedentary time
- Body composition
- Biological parameters
- Physical fitness
- Psychological parameters At the end of the protocol, there will be an assessment of the obstacles or motivations to this program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling workstation | Experimental | Behavioral: cyclingParticipants will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 6 months |
| control | Placebo comparator | Behavioral: cyclingDaily activities unchanged during 3 months. Then they will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 3 months. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteer, male or female, between 18 and 61 years old
- Body mass index > 18,5 kg/m2 and ≤ 35 kg/m2
- More than 0.8 full time equivalent hours (FTE) with 75% of this time in a sitting position
- Able to provide informed consent to research participation
- Registered in the French social security system
Key exclusion criteria (22 listed)
- Work involving multiple periods of sitting interruptions >1 minute
- Subject using a sit-to-stand office desk or a swiss ball
- Sports activity > 2.5 hours/week
- Contact jobs (face-to-face with people)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| cyclingParticipants will have a portable pedal machine under their desk and will use it 60minutes per day | Behavioural | Cycling workstation, control |
Primary outcome
effects of the use of a cycling Workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time
Time frame: month 3
Quantify by the use of an accelerometer device wears at the hip
36 secondary outcomes
Body composition
Time frame: day 90
Body composition
Time frame: day 180
Body composition
Time frame: day 1
Biological parameters - insulin
Time frame: Day 1
Biological parameters - insulin
Time frame: Day 90
Biological parameters - insulin
Time frame: Day 180
Biological parameters - glucose
Time frame: Day 1
Biological parameters - glucose
Time frame: Day 90
Biological parameters - glucose
Time frame: Day 180
Biological parameters - triglycerides
Time frame: Day 1
Biological parameters - triglycerides
Time frame: Day 90
Biological parameters - triglycerides
Time frame: Day 180
Biological parameters - cholesterol
Time frame: Day 1
Biological parameters - cholesterol
Time frame: Day 90
Biological parameters - cholesterol
Time frame: Day 180
Biological parameters - CRP
Time frame: Day 1
Biological parameters - CRP
Time frame: Day 90
Biological parameters - CRP
Time frame: Day 180
Biological parameters - anandamide
Time frame: Day 1
Biological parameters - anandamide
Time frame: Day 90
Biological parameters - anandamide
Time frame: Day 180
Psychological assessment
Time frame: Day 1
Psychological assessment
Time frame: Day 90
Psychological assessment
Time frame: Day 180
Resting metabolic rate
Time frame: Day 1
Resting metabolic rate
Time frame: Day 90
Resting metabolic rate
Time frame: Day 180
Physical capacity
Time frame: Day 1
Physical capacity
Time frame: Day 90
Physical capacity
Time frame: Day 180
Muscle Strength
Time frame: Day 1
Muscle Strength
Time frame: Day 90
Muscle Strength
Time frame: Day 180
Quality of the time spend to physical activities and sedentary behaviour
Time frame: Day 1
Quality of the time spend to physical activities and sedentary behaviour
Time frame: Day 90
Quality of the time spend to physical activities and sedentary behaviour
Time frame: Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 38616275Nasir H, Dutheil F, Ramos I, Guirado T, de Saint-Vincent S, Thivel D, Metz L, Duclos M. Effects of portable pedal machines at work on lipoprotein subfraction profile in sedentary workers - the REMOVE study. Lipids Health Dis. 2024 Apr 14;23(1):105. doi: 10.1186/s12944-024-02098-w.
- Derived from this study: PubMed 35673701Guirado T, Metz L, Pereira B, Brun C, Birat A, Boscaro A, Bergouignan A, Thivel D, Duclos M. A 12-Week Cycling Workstation Intervention Improves Cardiometabolic Risk Factors in Healthy Inactive Office Workers. J Occup Environ Med. 2022 Aug 1;64(8):e467-e474. doi: 10.1097/JOM.0000000000002583. Epub 2022 Jun 11.
- Derived from this study: PubMed 34022938Guirado T, Metz L, Pereira B, Bergouignan A, Thivel D, Duclos M. Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial. Trials. 2021 May 22;22(1):359. doi: 10.1186/s13063-021-05317-2.
Related trials for Sedentary Behavior
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cycling in people with Sedentary Behavior, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 22 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 22 Jan 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 France. 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. Some participants in this study may receive a placebo. 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 Lise LACLAUTRE (04 73 75 11 95, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of the use of a cycling Workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153214, which also lists 3 linked publications.
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 2020.