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Functional Training for the Prevention of Deep Venous Thrombosis

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ClinicalTrials.gov Identifier: NCT03740633
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Ankle Motion Gynecologic Neoplasm Deep Venous Thrombosis Abdominal Breathing 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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Patients in the study group accept functional training and regular care.
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.

Behavioral: 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

Active Comparator: Control group
Patients in the control group only accept regular care.
Combination Product: Regular care
Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization




Primary Outcome Measures :
  1. deep venous thrombosis [ Time Frame: One years ]
    incidence of deep venous thrombosis


Secondary Outcome Measures :
  1. adverse events [ Time Frame: One year ]
    adverse events related to the functional training

  2. patient satisfaction [ Time Frame: One year ]
    patient satisfaction surveyed by customed questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740633


Contacts
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Contact: Lei Li, M.D. +8613911988831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03740633     History of Changes
Other Study ID Numbers: GO-FUN
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Genital Neoplasms, Female
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Urogenital Neoplasms
Neoplasms by Site
Neoplasms