Functional Training for the Prevention of Deep Venous Thrombosis

Phase 3

• Conditions: Ankle Motion; Abdominal Breathing; Gynecologic Neoplasm; Deep Venous Thrombosis
• Interventions: Behavioral: passive ankle pump motions on the day of surgery; Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery; Combination Product: Regular care

• Registration Number: NCT03740633
• Lead Sponsor: Lei Li

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-10
• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-10
• Last Update Submitted: 2018-11-10
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 398

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Regular care	Patients in the study group accept functional training and regular care.
Study group	passive ankle pump motions on the day of surgery	Patients in the study group accept functional training and regular care.
Control group	Regular care	Patients in the control group only accept regular care.
Study group	active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery	Patients in the study group accept functional training and regular care.

Primary Outcome Measures

Name	Time	Method
deep venous thrombosis	One years	incidence of deep venous thrombosis

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	One year	patient satisfaction surveyed by customed questionnaire
adverse events	One year	adverse events related to the functional training

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China