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

NCT ID: NCT04711421

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-05-01

Brief Summary

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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

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Conditions

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Surgery Mobilization Gynecologic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

4 VIVOFIT-

Intervention Type DEVICE

Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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4 VIVOFIT-

Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Aviad Cohen, MD

Role: primary

972-547333450

Ido Laskov, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32459426 (View on PubMed)

Other Identifiers

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0689-19

Identifier Type: -

Identifier Source: org_study_id

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