Ankle MotionPhase 3NCT03740633
Functional Training for the Prevention of Deep Venous Thrombosis
A Phase 3 study testing 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 and Regular care in people with Ankle Motion and Gynecologic Neoplasm, run by Lei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ankle Motion, Gynecologic Neoplasm, Deep Venous Thrombosis
- What is being tested?
- 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 and Regular care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 10 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting all of the inclusion criteria
- Delayed extubation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
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
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.
- Being tested
- 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
- Medical subject headings
- Genital Neoplasms, Female, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive ankle pump motions on the day of surgeryBehavioural
Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.
active ankle pump motions and abdominal breathing training on the 1-3 day after the surgeryBehavioural
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.
Regular careCombination product
Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients in the study group accept functional training and regular care. Receives: 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 |
| Control group | Active comparator | Patients in the control group only accept regular care. Receives: Combination Product: Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
deep venous thrombosis
incidence of deep venous thrombosis
Measured: One years
Secondary outcomes (2)
adverse events
adverse events related to the functional training
Measured: One year
patient satisfaction
patient satisfaction surveyed by customed questionnaire
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start10 Nov 2018
- Primary completion10 Nov 2019 (estimated)
- Study completion10 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle MotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740633
- Sponsor's protocol ID
- GO-FUN
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03740633
- Acronym / sponsor ID
- GO-FUN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 10 Nov 2019 (estimated)
- Study completion
- 10 Nov 2019 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | 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 carePatients in the study group accept functional training and regular care. |
| Control group | Active comparator | Combination Product: Regular carePatients in the control group only accept regular care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Not meeting all of the inclusion criteria
- Delayed extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive ankle pump motions on the day of surgeryPassive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery. | Behavioural | Study group |
| active ankle pump motions and abdominal breathing training on the 1-3 day after the surgeryActive 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. | Behavioural | Study group |
| Regular careRegular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization | Combination product | Control group, Study group |
Primary outcome
deep venous thrombosis
Time frame: One years
incidence of deep venous thrombosis
2 secondary outcomes
adverse events
Time frame: One year
patient satisfaction
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 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 and Regular care in people with Ankle Motion and Gynecologic Neoplasm, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deep venous thrombosis (time frame: One years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.