Functional Training for the Prevention of Deep Venous Thrombosis

November 10, 2018 updated by: Lei Li

The Effects of Post-operative Functional Training on the Prevention of Deep Venous Thrombosis in the Patients of Gynecological Malignancies: A Phase 3 Randomized Control Study

This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

398

Phase

  • Phase 3

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Having received major surgeries for gynecologic malignancies
  • Good performance status
  • Aged 18 years or older
  • Signed an approved informed consents
  • No injuries to the skin, musculoskeletal system
  • No venous thromboembolic disease before surgeries

Exclusion Criteria:

  • Not meeting all of the inclusion criteria
  • Delayed extubation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Patients in the study group accept functional training and regular care.
Behavioral: passive ankle pump motions on the day of surgery
Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.
Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery
Active ankle pump motions include flexion and extension, circumduction, which will be conducted by patient on the 1-3 day after the surgery. On the same time, the patient is given abdominal breathing training.
Combination product: Regular care
Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization
Active Comparator: Control group
Patients in the control group only accept regular care.
Combination product: Regular care
Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
deep venous thrombosis
Time Frame: One years
incidence of deep venous thrombosis
One years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: One year
adverse events related to the functional training
One year
patient satisfaction
Time Frame: One year
patient satisfaction surveyed by customed questionnaire
One year

Collaborators and Investigators

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

Sponsor

Lei Li

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)

November 10, 2018

Primary Completion (Anticipated)

November 10, 2019

Study Completion (Anticipated)

November 10, 2019

Study Registration Dates

First Submitted

November 10, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 10, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO-FUN

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.

Clinical Trials on Deep Venous Thrombosis

Clinical Trials on passive ankle pump motions on the day of surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe