Exercise training for the treatment of post-thrombotic syndrome: the EXPO pilot trial

INTERVENTION: Active Training: Six‐month exercise training program designed to improve leg strength, leg endurance, leg flexibility and general cardiovascular fitness. Attention Control: Six‐month program consisting of: 1. Standardised one‐hour education session on PTS (what PTS is, why patients get it, how to manage it; exercise will be kept 'neutral', i.e., not specifically addressed) given by a trained thrombosis nurse‐educator not involved with the assessment of study outcomes, and 2. Monthly phone contacts by the same thrombosis nurse to 'check in' with the patient, ask about their PTS and provide support Contact for public queries: Adrielle H. Houweling Clinical Trial Coordinator, The EXPO Pilot Trial Sir Mortimer B. Davis Jewish General Hospital 3755 Cote St. Catherine, rm. A‐121 Montreal, Quebec H3T 1E2 Canada Tel: +1 514 340 8222 ext. 4717 Fax: +1 514 340 7564 CONDITION: Post‐thrombotic syndrome ; Circulatory System ; Other venous embolism and thrombosis PRIMARY OUTCOME: Feasibility indicators (measured throughout trial):; 1. Proportion of patients screened who are eligible to participate in the trial; 2. Proportion of eligible patients who consent to participate in the trial; 3. Proportion of subjects who are adherent with the intervention ; 4. Proportion of subjects who complete the trial SECONDARY OUTCOME: 1. Venous disease‐specific, measured at baseline, 3 months and 6 months; 2. Generic QOL, measured at baseline, 3 months and 6 months; 3. Severity of PTS (Villalta PTS Scale), measured at baseline, 3 months and 6 months; 4. Leg (triceps surae) strength, measured at baseline, 3 months and 6 months; 5. Leg flexibility, measured at baseline, 3 months and 6 months; 6. Time‐on‐treadmill, measured at pre‐randomisation and 6 months INCLUSION CRITERIA: 1. Aged 18 ‐ 75 years, either sex 2. Previous unilateral deep vein thrombosis (DVT) diagnosed using standardised ultrasound or venographic criteria 3. PTS in same leg as previous DVT (Villalta PTS Scale score greater than 4)