Functional Training for the Prevention of Deep Venous Thrombosis

NCT ID: NCT03740633

Last Updated: 2018-11-14

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

PHASE3

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2019-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Motion Gynecologic Neoplasm Deep Venous Thrombosis Abdominal Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study group

Patients in the study group accept functional training and regular care.

Group Type EXPERIMENTAL

passive ankle pump motions on the day of surgery

Intervention Type BEHAVIORAL

Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.

active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery

Intervention Type BEHAVIORAL

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.

Regular care

Intervention Type COMBINATION_PRODUCT

Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization

Control group

Patients in the control group only accept regular care.

Group Type ACTIVE_COMPARATOR

Regular care

Intervention Type COMBINATION_PRODUCT

Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Regular care

Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

* Delayed extubation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

+8613911988831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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GO-FUN

Identifier Type: -

Identifier Source: org_study_id

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