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

Not Applicable

• Conditions: Surgery; Mobilization; Gynecologic Cancer
• Interventions: Device: 4 VIVOFIT-

• Registration Number: NCT04711421
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental: Feedback	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

Primary Outcome Measures

Name	Time	Method
Number of steps per day during the hospitalization period	Up to 1 week	umber of steps taken by patient as recirded by pedometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel