PT - JOURNAL ARTICLE AU - Kahn, Susan R. AU - Shrier, Ian AU - Shapiro, Stan AU - Houweling, Adrielle H. AU - Hirsch, Andrew M. AU - Reid, Robert D. AU - Kearon, Clive AU - Rabhi, Khalil AU - Rodger, Marc A. AU - Kovacs, Michael J. AU - Anderson, David R. AU - Wells, Philip S. TI - Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial AID - 10.1503/cmaj.100248 DP - 2011 Jan 11 TA - Canadian Medical Association Journal PG - 37--44 VI - 183 IP - 1 4099 - http://www.cmaj.ca/content/183/1/37.short 4100 - http://www.cmaj.ca/content/183/1/37.full SO - CMAJ2011 Jan 11; 183 AB - Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial.