SurgeryNCT04711421
Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.
A study testing 4 VIVOFIT- in people with Surgery and Mobilization, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery, Mobilization, Gynecologic Cancer
- What is being tested?
- 4 VIVOFIT-
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2020to 1 May 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients following gynecology and gynecology oncology surgery Consent to participation No medical recommendation for bed rest and limited mobility
Who cannot join
- Refusal to participate Medical recommendation to limit mobility
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv, 64239
Aviad Cohen, MD, 972-547333450, co.aviad@gmail.com
Ido Laskov, MD, idolaskov@yahoo.com
About this study
This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.
- Conditions
- Surgery, Mobilization, Gynecologic Cancer
- Being tested
- 4 VIVOFIT-
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 VIVOFIT-Device
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Feedback | Experimental | Patients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve feedback regrding the number of steps taken by them at the end of each day Receives: Device: 4 VIVOFIT- |
| No Intervention: Control | No intervention | Patients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve no feedback regrding the number of steps taken by them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps per day during the hospitalization period
umber of steps taken by patient as recirded by pedometer
Measured: Up to 1 week
Secondary outcomes (4)
Number of participants with complication following surgery
infectious ( wound), blood product transfusion
Measured: Up to 1 week
Number of analgesic doses
Number of doses of analgesics consumed by patient
Measured: Up to 1 week
Length of hospitalization
Duration of hospitalization following surgery
Measured: Up to 4 week
Number of thromboembolic events
hromboembolic events, including deep vein thrombosis and pulmonary emboli
Measured: Up to 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 May 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711421
- Sponsor's protocol ID
- 0689-19
- Status last verified
- May 2020
- First submitted
- 9 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
PubMed 32459426
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.
- ClinicalTrials.gov ID
- NCT04711421
- Acronym / sponsor ID
- 0689-19
- Conditions
- Surgery, Mobilization, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Feedback | Experimental | Device: 4 VIVOFIT-Patients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve feedback regrding the number of steps taken by them at the end of each day |
| No Intervention: Control | No intervention | –Patients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve no feedback regrding the number of steps taken by them. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients following gynecology and gynecology oncology surgery Consent to participation No medical recommendation for bed rest and limited mobility
Key exclusion criteria (1 listed)
- Refusal to participate Medical recommendation to limit mobility
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 |
|---|---|---|
| 4 VIVOFIT-Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team | Device | Experimental: Feedback |
Primary outcome
Number of steps per day during the hospitalization period
Time frame: Up to 1 week
umber of steps taken by patient as recirded by pedometer
4 secondary outcomes
Number of participants with complication following surgery
Time frame: Up to 1 week
Number of analgesic doses
Time frame: Up to 1 week
Length of hospitalization
Time frame: Up to 4 week
Number of thromboembolic events
Time frame: Up to 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 32459426Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
- Individual participant dataSharing planned: No
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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 4 VIVOFIT- in people with Surgery and Mobilization, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 15 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps per day during the hospitalization period (time frame: Up to 1 week). 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 NCT04711421, which also lists 1 linked publication.
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 15 Jan 2021.