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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711421
• Other study ID #: 0689-19
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Mobilization
• Surgery

Intervention

Device:
• 4 VIVOFIT-
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps per day during the hospitalization period	umber of steps taken by patient as recirded by pedometer	Up to 1 week
Secondary	Number of participants with complication following surgery	infectious ( wound), blood product transfusion	Up to 1 week
Secondary	Number of analgesic doses	Number of doses of analgesics consumed by patient	Up to 1 week
Secondary	Length of hospitalization	Duration of hospitalization following surgery	Up to 4 week
Secondary	Number of thromboembolic events	hromboembolic events, including deep vein thrombosis and pulmonary emboli	Up to 4 week