Functional Training for the Prevention of Deep Venous Thrombosis

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740633
• Other study ID #: GO-FUN
• Status: Recruiting
• Phase: Phase 3
• Start date: November 10, 2018
• Est. completion date: November 10, 2019

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Breathing
• Ankle Motion
• Deep Venous Thrombosis
• Genital Neoplasms, Female
• Gynecologic Neoplasm
• Thrombosis
• Venous Thrombosis

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deep venous thrombosis	incidence of deep venous thrombosis	One years
Secondary	adverse events	adverse events related to the functional training	One year
Secondary	patient satisfaction	patient satisfaction surveyed by customed questionnaire	One year