Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

• Published in: Canadian Medical Association journal (CMAJ) Vol. 183; no. 1; pp. 37 - 44
• Main Authors: Kahn, Susan R, Shrier, Ian, Shapiro, Stan, Houweling, Adrielle H, Hirsch, Andrew M, Reid, Robert D, Kearon, Clive, Rabhi, Khalil, Rodger, Marc A, Kovacs, Michael J, Anderson, David R, Wells, Philip S
• Format: Journal Article
• Language: English
• Published: Canada Joule Inc 11.01.2011; CMA Impact, Inc; Canadian Medical Association
• Subjects: Adolescent; Adult; Aged; Blood clot; Care and treatment; Cohort Studies; Development and progression; Effectiveness studies; Exercise; Exercise (intensity); Exercise Tolerance; Feasibility Studies; Female; Health aspects; Humans; Male; Medical treatment; Methods; Middle Aged; Patient outcomes; Pilot Projects; Postthrombotic Syndrome - etiology; Postthrombotic Syndrome - physiopathology; Postthrombotic Syndrome - therapy; Quality of Life; Thrombosis; Treatment Outcome; Young Adult; Canada
• ISSN: 0820-3946; 1488-2329
• DOI: 10.1503/cmaj.100248

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. 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. 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. 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.