Back to resultsFunctional Training for the Prevention of Deep Venous Thrombosis
Primary Purpose
Ankle Motion, Gynecologic Neoplasm, Deep Venous Thrombosis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
passive ankle pump motions on the day of surgery
active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery
Regular care
Sponsored by
About this trial
This is an interventional prevention trial for Ankle Motion
Eligibility Criteria
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Patients in the study group accept functional training and regular care.
Patients in the control group only accept regular care.
Outcomes
Primary Outcome Measures
deep venous thrombosis
incidence of deep venous thrombosis
Secondary Outcome Measures
adverse events
adverse events related to the functional training
patient satisfaction
patient satisfaction surveyed by customed questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03740633
Brief Title
Functional Training for the Prevention of Deep Venous Thrombosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Anticipated)
Study Completion Date
November 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Motion, Gynecologic Neoplasm, Deep Venous Thrombosis, Abdominal Breathing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
398 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients in the study group accept functional training and regular care.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in the control group only accept regular care.
Intervention Type
Behavioral
Intervention Name(s)
passive ankle pump motions on the day of surgery
Intervention Description
Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.
Intervention Type
Behavioral
Intervention Name(s)
active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Regular care
Intervention Description
Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization
Primary Outcome Measure Information:
Title
deep venous thrombosis
Description
incidence of deep venous thrombosis
Time Frame
One years
Secondary Outcome Measure Information:
Title
adverse events
Description
adverse events related to the functional training
Time Frame
One year
Title
patient satisfaction
Description
patient satisfaction surveyed by customed questionnaire
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+8613911988831
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
008613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Learn more about this trial
Functional Training for the Prevention of Deep Venous Thrombosis
We'll reach out to this number within 24 hrs