EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial (EXPECT)
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ClinicalTrials.gov Identifier: NCT01853202 |
Recruitment Status
:
Completed
First Posted
: May 14, 2013
Last Update Posted
: December 4, 2014
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Condition or disease | Intervention/treatment | Phase |
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Cancer Thrombosis | Behavioral: Supervised aerobic exercise training | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1 - Supervised aerobic exercise training
This group will participate in 3 supervised exercise sessions/week at an intensity of 50%-70% of the individually determined VO2max between 30-45 min/session for 12 weeks. The aerobic training intervention will closely mimic the standard exercise-based guidelines adopted in cardiac rehabilitation. All intervention sessions will be performed in a supervised setting with one-on-one supervision by an American College of Sports Medicine-certified exercise physiologist. Aerobic exercise training will be prescribed based on the guiding ACSM principles with the aim of improving VO2max. Walking was chosen because it is the preferred mode of exercise training in cancer patients.
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Behavioral: Supervised aerobic exercise training |
No Intervention: Group 2
The 12-week program will consist of monthly phone contacts to check in with patient and review their exercise log entries for that month in order to capture physical activity done outside of the intervention setting.
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- Thrombin Generation [ Time Frame: 12 weeks ]The primary endpoint will be thrombin generation, a marker of VTE risk in cancer.

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of lymphoma or cancer
- Beginning chemotherapy regimen
- Patient self-report of ability to walk 10 minutes without interruption or pain
- Age >18 and <80
- Willingness to participate in the oncology rehabilitation program at Tilley Drive South Burlington
Exclusion Criteria:
- Presence or history of DVT or PE prior to entry
- Antithrombotic therapy including warfarin, dabigatran, low molecular weight heparin or unfractionated heparin which will alter levels of hemostatic factors (Off Lovenox 48 hours before first study blood draw)
- Medical condition that alters ability to walk for exercise

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): NCT01853202
United States, Vermont | |
Fletcher Allen Healthcare | |
Burlington, Vermont, United States, 05401 |
Principal Investigator: | Susan G Lakoski, MD | University of Vermont |
Publications:
Responsible Party: | Susan Lakoski, Assistant Professor, University of Vermont College of Medicine, University of Vermont |
ClinicalTrials.gov Identifier: | NCT01853202 History of Changes |
Other Study ID Numbers: |
VCC 1220 |
First Posted: | May 14, 2013 Key Record Dates |
Last Update Posted: | December 4, 2014 |
Last Verified: | December 2014 |
Keywords provided by Susan Lakoski, University of Vermont:
Cancer Chemotherapy Thrombosis Prevention Exercise |
Additional relevant MeSH terms:
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |