Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.

January 14, 2021 updated by: Tel-Aviv Sourasky Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
        • Principal Investigator:
          • eli shprecher, prof.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patients following gynecology and gynecology oncology surgery Consent to participation No medical recommendation for bed rest and limited mobility

Exclusion Criteria:

Refusal to participate Medical recommendation to limit mobility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Feedback
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
Device: 4 VIVOFIT-
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
No Intervention: No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complication following surgery
Time Frame: Up to 1 week
infectious ( wound), blood product transfusion
Up to 1 week
Number of analgesic doses
Time Frame: Up to 1 week
Number of doses of analgesics consumed by patient
Up to 1 week
Length of hospitalization
Time Frame: Up to 4 week
Duration of hospitalization following surgery
Up to 4 week
Number of thromboembolic events
Time Frame: Up to 4 week
hromboembolic events, including deep vein thrombosis and pulmonary emboli
Up to 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0689-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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