Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial
- 22 November 2010
- journal article
- research article
- Published by CMA Impact Inc. in CMAJ : Canadian Medical Association Journal
- Vol. 183 (1), 37-44
- https://doi.org/10.1503/cmaj.100248
Abstract
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.Keywords
This publication has 30 references indexed in Scilit:
- How I treat postthrombotic syndromeBlood, 2009
- Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndromeJournal of Thrombosis and Haemostasis, 2009
- Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardizationJournal of Thrombosis and Haemostasis, 2009
- Treadmill Exercise and Resistance Training in Patients With Peripheral Arterial Disease With and Without Intermittent ClaudicationJama-Journal Of The American Medical Association, 2009
- The design and interpretation of pilot trials in clinical research in critical careCritical Care Medicine, 2009
- Risk factors for post‐thrombotic syndrome in patients with a first deep venous thrombosisJournal of Thrombosis and Haemostasis, 2008
- Evaluation of a venous-return assist device to treat severe post-thrombotic syndrome (VENOPTS)Thrombosis and Haemostasis, 2008
- Mind-Set MattersPsychological Science, 2007
- Reliability of a device measuring triceps surae muscle fatigabilityBritish Journal of Sports Medicine, 2004
- Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trialJournal of Vascular Surgery, 2004