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Functional Training for the Prevention of Deep Venous Thrombosis

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03740633
Enrollment
398
Registered
2018-11-14
Start date
2018-11-10
Completion date
2019-11-10
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Motion, Gynecologic Neoplasm, Deep Venous Thrombosis, Abdominal Breathing

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.

Interventions

BEHAVIORALpassive 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.

BEHAVIORALactive 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_PRODUCTRegular care

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

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
deep venous thrombosisOne yearsincidence of deep venous thrombosis

Secondary

MeasureTime frameDescription
adverse eventsOne yearadverse events related to the functional training
patient satisfactionOne yearpatient satisfaction surveyed by customed questionnaire

Countries

China

Contacts

Primary ContactLei Li, M.D.
lileigh@163.com+8613911988831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026