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| Name | Class |
|---|---|
| University of Maryland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard care: anticoagulation, compression, and ad-lib ambulation |
|
| Exercise | Experimental | Standard care + Interventional Exercise therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Upper and Lower extremity exercise |
| |
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change from baseline to 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brajesh K Lal, MD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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Of 107 enrolled participants, 102 were randomized to one of the treatment groups.
Adult (18+) patients who recently experienced acute lower extremity Deep Vein Thrombosis (DVT) were screened and enrolled within 28 days of the DVT diagnosis, received a 3-month treatment (either standard care alone or standard care + exercise program), followed for 2 years, and evaluated at 1 month, 3 months, 6 months, 1 year, and 2 years. Participants were recruited from a vascular imaging lab based on physician referral. Participants were enrolled September 2014 - June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard care (anticoagulation, compression, and ad-lib ambulation) |
| FG001 | Exercise | Standard care + 3-month exercise therapy Exercise: upper and lower extremity exercise Standard care: anticoagulation, compression, and ad-lib ambulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with acute DVT
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard care (anticoagulation, compression, and ad-lib ambulation) |
| BG001 | Exercise | Standard care + 3-month exercise therapy Exercise: upper and lower extremity exercise Standard care: anticoagulation, compression, and ad-lib ambulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who underwent physical examination at baseline and at the 2-year visit (some patients could not tolerate the physical examination necessary to ascertain Villalta score, and some patients did not complete a 2-year follow-up visit). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 2-year follow-up |
Adverse events were collected for 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard care: anticoagulation, compression & ad-lib ambulation Control: Standard care: anticoagulation, compression & ad-lib ambulation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment | Chronic renal failure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brajesh K. Lal | Veterans Administration of Baltimore Maryland | 410-328-5840 | blal@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2023 | Jan 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2019 | Jan 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Other |
anticoagulation, compression, and ad-lib ambulation |
|
| 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. | Change from baseline to 3-month follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Villalta score | 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 minimum possible score is 0, and the maximum possible score is 33. | Patients who underwent physical examination at baseline (some patients could not tolerate the physical examination necessary to ascertain Villalta score). | Mean | Standard Deviation | units on a scale |
|
| 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 minimum possible score is 25 and the maximum possible score is 117. | Patients who completed the VEINES-QOL questionnaire at baseline (some patients refused or were unable to complete the questionnaire). | Mean | Standard Deviation | units on a scale |
|
| 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:
Higher scores denote better quality of life. For each domain score, the minimum possible score is 0 and the maximum possible score is 100. | Patients who completed the SF-36 questionnaire at baseline (some patients refused or were unable to complete the questionnaire). | Mean | Standard Deviation | units on a scale |
|
| Thrombus volume | Patients for whom thrombus volume could be determined through imaging (thrombus volume could not be determined for some patients). | Mean | Standard Deviation | mL |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Control | Standard care (anticoagulation, compression, and ad-lib ambulation) |
| OG001 | Exercise | Standard care + 3-month exercise therapy Exercise: upper and lower extremity exercise Standard care: anticoagulation, compression, and ad-lib ambulation |
|
|
|
| Primary | 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. | Patients who completed the VEINES-QOL questionnaire at baseline and at the 2-year visit (some patients refused or were unable to complete the questionnaire, and some patients did not complete a 2-year follow-up visit). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 2-year follow-up |
|
|
|
|
| Secondary | 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:
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. | Patients who completed the SF-36 questionnaire at baseline and at the 2-year visit (some patients refused or were unable to complete the questionnaire, and some patients did not complete a 2-year follow-up visit). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 2-year follow-up |
|
|
|
|
| Secondary | 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. | Patients for whom thrombus volume could be determined through imaging at baseline and at the 3-month visit (thrombus volume could not be determined for some patients, and some patients did not complete a 3-month follow-up visit). | Posted | Mean | Standard Deviation | Percent of baseline thrombus size | Change from baseline to 3-month follow-up |
|
|
|
|
| Post-Hoc | Villalta Score in People With vs Without Common Femoral Reflux | Common femoral reflux (yes/no) is used as a measure of hemodynamics; determined through lower extremity Ultrasonography. 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 minimum possible score is 0, and the maximum possible score is 33. | Patients who underwent physical examination (to ascertain Villalta score) as well as lower extremity Ultrasonography (to assess hemodynamics of the common femoral vein) at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Post-Hoc | Time Required to Walk 400 Meters in Patients With vs Without PTS | The 400-meter walk tests exercise capacity. Post-thrombotic syndrome (PTS) is defined as a Villalta score of 5 or higher. | Patients who underwent physical examination to ascertain Villalta score and completed 400-meter walk at baseline (some patients could not tolerate physical examination and some patients were unable to complete walk). | Posted | Mean | Standard Deviation | minutes | Baseline |
|
|
|
|
| 6 |
| 48 |
| 14 |
| 48 |
| 0 |
| 48 |
| EG001 | Exercise | Standard care + Interventional Exercise therapy Exercise: Upper and Lower extremity exercise Standard care: anticoagulation, compression & ad-lib ambulation | 3 | 54 | 9 | 54 | 0 | 54 |
|
| Hernia repair | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment | incarcerated ventral hernia |
|
| Bowel Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment | Bowel obstruction by tumor |
|
| Colon Cancer | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment | Colon |
|
| Prostate Cancer | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment | Prostate Cancer |
|
| Chronic Pain After Fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment | Chronic pain after hip and ankle fracture |
|
| Cholecystectomy | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment | Gallbladder removal surgery |
|
| Neuroendocrine tumor | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment | neuroendocrine tumor |
|
| Disseminated infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment | Disseminated infection with suspected Nocardia(bacteria) |
|
| Tumor | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment | Lung Biopsy |
|
| Gun Shot Wound | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment | Gun Shot Wound |
|
| Respirtory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment | Pneumonia and Shortness of Breath |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment | Pulmonary Embolism |
|
| Gastrointestinal Bleed | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment | Upper Gastrointestinal Bleed |
|
| Intracranial bleeding | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment | Intracranial bleeding |
|
| Homicidal ideation | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment | worsening of bipolar disorder and homicidal ideation |
|
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| D014689 |
| Venous Insufficiency |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change in RE domain score |
|
| Change in VT domain score |
|
| Change in MH domain score |
|
| Change in SF domain score |
|
| Change in BP domain score |
|
| Change in GH domain score |
|
Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score. |
| t-test, 2 sided |
| 0.13 |
| Mean Difference (Net) |
| 5.0 |
| Standard Error of the Mean |
| 3.3 |
| 2-Sided |
| 95 |
| -1.6 |
| 11.6 |
Mean difference = Exercise - Control |
| Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score. | t-test, 2 sided | 0.33 | Mean Difference (Net) | 2.7 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -2.8 | 8.2 | Mean difference = Exercise - Control | Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score. | t-test, 2 sided | 0.43 | Mean Difference (Net) | 5.6 | Standard Error of the Mean | 7.1 | 2-Sided | 95 | -8.7 | 20.0 | Mean difference = Exercise - Control | Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score. | t-test, 2 sided | 0.64 | Mean Difference (Net) | -2.6 | Standard Error of the Mean | 5.6 | 2-Sided | 95 | -13.8 | 8.6 | Mean difference = Exercise - Control | Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score. | t-test, 2 sided | 0.64 | Mean Difference (Net) | -3.9 | Standard Error of the Mean | 8.3 | 2-Sided | 95 | -20.5 | 12.8 | Mean difference = Exercise - Control | Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score. | t-test, 2 sided | 0.35 | Mean Difference (Net) | 9.5 | Standard Error of the Mean | 10.1 | 2-Sided | 95 | -10.7 | 29.7 | Mean difference = Exercise - Control | Superiority |
| Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score. | t-test, 2 sided | 0.50 | Mean Difference (Net) | -3.5 | Standard Error of the Mean | 5.3 | 2-Sided | 95 | -14.1 | 7.0 | Mean difference = Exercise - Control | Superiority |
| Control |
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| Control |
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