TY - JOUR
T1 - Six-month exercise training program to treat post-thrombotic syndrome
T2 - A randomized controlled two-centre trial
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.
N1 - Funding Information:
Competing interests: Susan Kahn is principal investigator of an ongoing trial funded by the Canadian Institutes for Health Research (CIHR) investigating active versus placebo compression stockings to prevent post-thrombotic syndrome after deep venous thrombosis, for which Sigvaris Corp. has provided active and placebo compression stockings. She is a coapplicant and steering committee member on an NIH-funded trial (funded by the United States National Institutes of Health) of pharmacomechanical catheter-directed thrombolysis plus standard anticoagulation alone. She has received honoraria to speak on post-thrombotic syndrome at various national and international academic conferences. Clive Kearon is principal investigator for a CIHR grant for the evaluation of a d-dimer-based management strategy for selecting patients with unprovoked venous thromboembolism for indefinite anticoagulation. He is a steering committee member for one recently completed and two ongoing studies of venous thromboembolism treatment by Boehringer Ingelheim. Marc Rodger served on an advisory board for Boehringer Ingelheim, Sanofi-Aventis and bioMérieux. He is appointed at the Ottawa Hospital Research Institute, which received compensation from Boehringer Ingelheim, Sanofi-Aventis, bioMérieux and LEO Pharma for this service. No competing interests declared by Ian Shrier, Stan Shapiro, Adrielle Houweling, Andrew Hirsch, Robert Reid, Khalil Rabhi, Michael Kovacs, David Anderson and Philip Wells.
Funding Information:
Funding: This study was funded by the CIHR Randomized Controlled Trials Program (grant no. MTC82338) . Susan Kahn is national investigator (chercheur national) of the Fonds de la recherche en santé du Québec (FRSQ). Ian Shrier was supported by an FRSQ Senior Clinician Scientist Award. Clive Kearon is a career investigator of the Heart and Stroke Foundation of Ontario and is supported by a CIHR Team Grant in Venous Thromboembolism (grant no. FRN 79846) . Marc Rodger is a career scientist of the Heart and Stroke Foundation of Ontario and is supported by the Early Researcher Award of the Ministry of Research and Innovation. Philip Wells and Marc Rodger hold Department of Medicine Research Awards, and Philip Wells holds a Canada Research Chair in Thromboembolic Diseases.
PY - 2011/1/11
Y1 - 2011/1/11
N2 - 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; ρ = 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; ρ = 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. (Trial registered at www .controlled-trials.com, no. ISRCTN56430072.)
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; ρ = 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; ρ = 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. (Trial registered at www .controlled-trials.com, no. ISRCTN56430072.)
UR - http://www.scopus.com/inward/record.url?scp=78651414572&partnerID=8YFLogxK
U2 - 10.1503/cmaj.100248
DO - 10.1503/cmaj.100248
M3 - Article
AN - SCOPUS:78651414572
SN - 0820-3946
VL - 183
SP - 37
EP - 44
JO - CMAJ
JF - CMAJ
IS - 1
ER -