EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial
Patients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting are at risk for blood clots which form in the veins. The occurrence of blood clots has major implications on personal health including the need for blood thinners and monitoring, potential bleeding, and complications related to blood clots on cardiovascular health. The goal of this study is to determine whether aerobic exercise training is a therapeutic strategy to offset risk of blood clots and improve quality of life among cancer patients during chemotherapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial|
- Thrombin Generation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary endpoint will be thrombin generation, a marker of VTE risk in cancer.
|Study Start Date:||March 2013|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
|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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01853202
|United States, Vermont|
|Fletcher Allen Healthcare|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Susan G Lakoski, MD||University of Vermont|