Post-thrombotic syndrome Circulatory System Other venous embolism and thrombosis
Conditions
Interventions
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 consisti
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 th
Sponsors
Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. Acute DVT within previous six months 2. Contra-indications to exercise training, e.g. arthritis of lower extremities, angina, symptomatic chronic obstructive lung disease, congestive heart failure, severe claudication, poor balance 3. Expected lifespan less than six months or general medical condition that would make study unfeasible, e.g. advanced cancer or cardiopulmonary disease 4. Pregnancy or lactation 5. Open venous leg ulcer 6. Not conversant in either English or French 7. Geographic inaccessibility which precludes participation 8. Unwilling or unable to provide signed informed consent 9. Screening (i.e. pre-randomisation) exercise stress test (Bruce Ramp protocol) demonstrating uncontrolled hypertension, ischaemia, or arrhythmia (such patients will be referred for appropriate medical evaluation)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed