Acute Deep Vein ThrombosisEFFORT2NCT02148029
Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
A study testing Exercise in people with Acute Deep Vein Thrombosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs progress to chronic post-clot problems resulting in significant disability, loss of productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the primary cause of post-clot problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Deep Vein Thrombosis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2014to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Lower Extremity DVT
- DVT documented by ultrasound, CT/Magnetic Resonance imaging (MR) venogram, or conventional venogram
- Enrolled within 4 weeks of onset of symptoms
- Age 18 years or older
Who cannot join
- Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with ankle brachial index (ABI)\<0.5
- Immediate need for thrombolysis/thrombectomy
- DVT involving the inferior vena cava (IVC)
- Contraindication to anticoagulation
- Contraindications to exercise training
- Medical illness interfering with evaluation/follow-up
Show all 10Show fewer
- Life expectancy \<2 years
- Pregnancy
- Inability to walk
- Hemodynamically significant PE
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs progress to chronic post-clot problems resulting in significant disability, loss of productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence of reverse flow. The investigators have observed that clot breakdown is enhanced by increased blood flow and that moderate arm and leg exercise result in increased venous blood flow. Hence, the investigators predict that a supervised exercise program in patients with deep vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the risk of post clot problems. The primary hypothesis is that increased blood flow across the clot (induced by supervised exercise) will increase clot breakdown and decrease severity of post clot problems. The investigators are conducting a randomized clinical trial of standard therapy compared to progressive exercise training in patients with leg deep vein clots.
Read the detailed description
Standard anticoagulation therapy for acute deep vein thrombosis (DVT) reflects the current short term focus on preventing pulmonary embolism (PE) and recurrent DVT. Despite standard care, 25% to 50% of patients with DVT progress to the chronic post-thrombotic syndrome (PTS) resulting in significant disability, loss of productivity, and healthcare costs. The investigators postulate that a supervised exercise program in patients with acute DVT could increase lower extremity venous flow, accelerate thrombus resolution, and thereby decrease the risk of PTS. If the patient is unable to perform exercises, neuromuscular electrical stimulation (NMES) will be used to induce contraction of the muscles of the lower extremities.
Aim 1 will test whether a 3-month exercise program has long-term clinical benefits in acute DVT. The primary outcome measures will be the 2-year change in Villalta score for PTS and VEINES-QOL score (Venous Insufficiency Epidemiological and Economic Study-QOL).
Aim 2 will evaluate whether exercise therapy in patients with acute DVT enhances thrombus resolution. The outcome measure will be 3-month change in thrombus volume.
Aim 3 will assess the relationship between PTS, venous hemodynamics and exercise capacity. The outcome measures will be Villalta score, common femoral reflux, and 400-meter walk time.
- Conditions
- Acute Deep Vein Thrombosis
- Being tested
- Exercise, Standard Care
- Keywords
- Deep vein thrombosis, Post thrombotic syndrome, Thrombus resolution
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Upper and Lower extremity exercise
Standard CareOther
anticoagulation, compression, and ad-lib ambulation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard care: anticoagulation, compression, and ad-lib ambulation Receives: Other: Standard Care |
| Exercise | Experimental | Standard care + Interventional Exercise therapy Receives: Other: Exercise; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Change in Villalta Score
The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). Higher Villalta scores denote more severe symptoms and greater likelihood of PTS.
The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year follow-up.
The range of the Villalta score is 0-33, so the minimum possible change is -33 and the maximum possible change is 33, with 0 indicating no change in Villalta scores (same score at baseline and at 2-year follow-up).
An increase (positive change) in Villalta score indicates worsening symptoms, while a decrease (negative change) indicates improving symptoms.
Measured: Change from baseline to 2-year follow-up
2-year Change in VEINES-QOL Summary Score
The VEINES-QOL summary score is calculated from the Venous Insufficiency Epidemiological and Economic Study (VEINES) Quality of Life (QOL) questionnaire, and it provides an estimate of the overall impact of deep venous thrombosis (DVT) on the patient's quality of life. A higher VEINES-QOL score indicates better quality of life.
The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year visit.
The range of the VEINES-QOL summary score is 25-117, so the minimum possible change is -92 and the maximum possible change is 92, with 0 indicating no change in VEINES-QOL scores (same score at baseline and at 2-year follow-up).
An increase (positive change) in VEINES-QOL score indicates an improvement in quality of life, and a decrease (negative change) indicates worsening quality of life.
Measured: Change from baseline to 2-year follow-up
Secondary outcomes (2)
2-year Change in SF-36 Domain Scores
The 36-Item Short Form survey (SF-36) produces 8 domain scores, each quantifying a different aspect of quality of life:
- PF = Physical Functioning
- RP = Role limitations due to Physical health problems
- RE = Role limitations due to mental health or Emotional problems
- VT = energy/fatigue/Vitality
- MH = Mental Health/emotional well-being
- SF = Social Functioning
- BP = Bodily Pain
- GH = General Health
The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year visit.
The range for each domain score is 0-100, so the minimum possible change is -100 and the maximum possible change is +100, with 0 indicating no change in domain scores (same score at baseline and at 2-year follow-up).
An increase (positive change) in a domain score indicates improvement in that specific aspect of quality of life, and a decrease (negative change) indicates worsening quality of life in that domain.
Measured: Change from baseline to 2-year follow-up
3-month Percent-change in Thrombus Volume
Percent-change in thrombus volume (mL) is calculated by subtracting the baseline volume from the volume at the 3-month visit then dividing the result by the baseline volume and multiplying by 100.
A negative change indicates a decrease in thrombus volume; i.e. the thrombus shrank in size and is therefore closer to complete resolution.
A percent-change of -100% indicates complete thrombus resolution.
Measured: Change from baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start15 Sep 2014
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Brajesh K Lal, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148029
- Sponsor's protocol ID
- F0995-R
- Acronym
- EFFORT2
- Status last verified
- Oct 2024
- First submitted
- 21 May 2014
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
- ClinicalTrials.gov ID
- NCT02148029
- Acronym / sponsor ID
- EFFORT2 / F0995-R
- Conditions
- Acute Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Post thrombotic syndrome, Thrombus resolution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Maryland
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs progress to chronic post-clot problems resulting in significant disability, loss of productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence of reverse flow. The investigators have observed that clot breakdown is enhanced by increased blood flow and that moderate arm and leg exercise result in increased venous blood flow. Hence, the investigators predict that a supervised exercise program in patients with deep vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the risk of post clot problems. The primary hypothesis is that increased blood flow across the clot (induced by supervised exercise) will increase clot breakdown and decrease severity of post clot problems. The investigators are conducting a randomized clinical trial of standard therapy compared to progressive exercise training in patients with leg deep vein clots.
Detailed description
Standard anticoagulation therapy for acute deep vein thrombosis (DVT) reflects the current short term focus on preventing pulmonary embolism (PE) and recurrent DVT. Despite standard care, 25% to 50% of patients with DVT progress to the chronic post-thrombotic syndrome (PTS) resulting in significant disability, loss of productivity, and healthcare costs. The investigators postulate that a supervised exercise program in patients with acute DVT could increase lower extremity venous flow, accelerate thrombus resolution, and thereby decrease the risk of PTS. If the patient is unable to perform exercises, neuromuscular electrical stimulation (NMES) will be used to induce contraction of the muscles of the lower extremities.
Aim 1 will test whether a 3-month exercise program has long-term clinical benefits in acute DVT. The primary outcome measures will be the 2-year change in Villalta score for PTS and VEINES-QOL score (Venous Insufficiency Epidemiological and Economic Study-QOL).
Aim 2 will evaluate whether exercise therapy in patients with acute DVT enhances thrombus resolution. The outcome measure will be 3-month change in thrombus volume.
Aim 3 will assess the relationship between PTS, venous hemodynamics and exercise capacity. The outcome measures will be Villalta score, common femoral reflux, and 400-meter walk time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard CareStandard care: anticoagulation, compression, and ad-lib ambulation |
| Exercise | Experimental | Other: Exercise, Other: Standard CareStandard care + Interventional Exercise therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute Lower Extremity DVT
- DVT documented by ultrasound, CT/Magnetic Resonance imaging (MR) venogram, or conventional venogram
- Enrolled within 4 weeks of onset of symptoms
- Age 18 years or older
Key exclusion criteria (10 listed)
- Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with ankle brachial index (ABI)\<0.5
- Immediate need for thrombolysis/thrombectomy
- DVT involving the inferior vena cava (IVC)
- Contraindication to anticoagulation
- Contraindications to exercise training
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 |
|---|---|---|
| ExerciseUpper and Lower extremity exercise | Other | Exercise |
| Standard Careanticoagulation, compression, and ad-lib ambulation | Other | Control, Exercise |
Primary outcome
2-year Change in Villalta Score
Time frame: Change from baseline to 2-year follow-up
The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). Higher Villalta scores denote more severe symptoms and greater likelihood of PTS. The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year follow-up. The range of the Villalta score is 0-33, so the minimum possible change is -33 and the maximum possible change is 33, with 0 indicating no change in Villalta scores (same score at baseline and at 2-year follow-up). An increase (positive change) in Villalta score indicates worsening symptoms, while a decrease (negative change) indicates improving symptoms.
2-year Change in VEINES-QOL Summary Score
Time frame: Change from baseline to 2-year follow-up
The VEINES-QOL summary score is calculated from the Venous Insufficiency Epidemiological and Economic Study (VEINES) Quality of Life (QOL) questionnaire, and it provides an estimate of the overall impact of deep venous thrombosis (DVT) on the patient's quality of life. A higher VEINES-QOL score indicates better quality of life. The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year visit. The range of the VEINES-QOL summary score is 25-117, so the minimum possible change is -92 and the maximum possible change is 92, with 0 indicating no change in VEINES-QOL scores (same score at baseline and at 2-year follow-up). An increase (positive change) in VEINES-QOL score indicates an improvement in quality of life, and a decrease (negative change) indicates worsening quality of life.
2 secondary outcomes
2-year Change in SF-36 Domain Scores
Time frame: Change from baseline to 2-year follow-up
3-month Percent-change in Thrombus Volume
Time frame: Change from baseline to 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Brajesh K Lal, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Acute Deep Vein Thrombosis, run by VA Office of Research and Development at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 2024. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Change in Villalta Score (time frame: Change from baseline to 2-year follow-up). The study lists 2 primary outcomes in all. 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 23 Oct 2024.