Functional Training for the Prevention of Deep Venous Thrombosis

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* 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


Participation Criteria
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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 Exclusion Criteria: Not meeting all of the inclusion criteria Delayed extubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients in the study group accept functional training and regular care. | Behavioral: passive ankle pump motions on the day of surgery<br>* Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.<br>Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery<br>* 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.<br>Combination Product: Regular care<br>* Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization<br>|
| Active Comparator: Control group<br>Patients in the control group only accept regular care. | Combination Product: Regular care<br>* Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deep venous thrombosis | incidence of deep venous thrombosis | One years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | adverse events related to the functional training | One year | 
| patient satisfaction | patient satisfaction surveyed by customed questionnaire | One year |