Functional Training for the Prevention of Deep Venous Thrombosis

Lei Li

Status and phase: Unknown; Phase 3

Conditions: Gynecologic Neoplasm; Abdominal Breathing; Deep Venous Thrombosis; Ankle Motion

Treatments: Combination Product: Regular care; Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery; Behavioral: passive ankle pump motions on the day of surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03740633

GO-FUN

Details and patient eligibility

About

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.

Enrollment: 398 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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398 participants in 2 patient groups

Study group

Experimental group

Description:

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

Treatment:

Combination Product: Regular care

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

Control group

Active Comparator group

Description:

Patients in the control group only accept regular care.

Treatment:

Combination Product: Regular care