Abstract
Abstract 3984
Poster Board III-920
Exercise training is an effective treatment for lower limb arterial claudication and may also have the potential to improve the post-thrombotic syndrome (PTS).
We conducted a randomized, allocation concealed, controlled, assessor-blinded multicenter pilot trial to provide preliminary data on the effectiveness of a 6-month exercise training program in improving the PTS.
Patients aged 18-75 years with unilateral DVT diagnosed >6 months previously and ipsilateral PTS (Villalta criteria) were screened for participation in the trial at 2 centres in Canada (Montreal & Ottawa). Eligible, consenting patients were randomized to Active Training (AT), a 26-week trainer-supervised program consisting of leg strengthening, leg stretching and aerobic exercise, or Attention Control (AC), a 1-hour presentation on PTS + monthly phone follow-ups. Participants had study visits at Baseline (T0), 3 mths (T3) and 6 mths (T6) to measure generic (SF-36) and venous disease-specific (VEINES-QOL) quality of life (QOL), PTS severity (Villalta scale), leg strength (number of heel lifts) and leg flexibility (stretch angle, in degrees, for quadriceps, hamstring, gastrocnemius and soleus muscles). Within-subject changes from T0 to T6 were compared in AT vs. AC using repeated measures two-way ANOVA.
From 2007-2008, 43 patients were recruited (21 randomized to AT, 22 to AC). Mean age was 47 years, 44% were male, and 49% had moderate or severe PTS. At 3 and 6 mths, PTS severity category improved in 65% of AT vs. 26% of AC (p=0.02) and 61% of AT vs. 46% of AC (p=ns), respectively. Other results are shown in Table (for all outcomes except Villalta score, + change signifies improvement from T0 to T6).
| Outcome measure . | Active Training Within subject change, T6-T0, Mean (SD) . | Attention Control Within subject change, T6-T0, Mean (SD) . | Between-group (AT vs. AC), within subject difference, T6- T0, Mean (95% CI) . | P value for interaction between treatment group and time . | P value, age and sex adjusted . |
|---|---|---|---|---|---|
| VEINES-QOL score | 6.0 (5.1) | 1.4 (7.2) | +4.6 (0.54, 8.7) | 0.027 | 0.052 |
| SF-36 Physical Component Score | 5.6 (7.7) | 0.2 (7.6) | +5.4 (0.5, 10.4) | 0.03 | 0.09 |
| Villalta score | -3.6 (3.7) | -1.6 (4.3) | -2.0 (-4.6, 0.6) | 0.14 | 0.12 |
| Number heel lifts | 5.2 (10.6) | -2.5 (10.6) | +7.7 (0.7, 14.7) | 0.03 | 0.04 |
| Stretch angle quadriceps (°) | 10.2 (20.5) | 0.3 (6.6) | +9.9 (-1.0, 20.7) | 0.04 | 0.04 |
| Stretch angle hamstring (°) | 2.7 (11.0) | -3.7 (22.7) | +6.4 (-5.8, 18.5) | 0.29 | 0.47 |
| Stretch angle gastroc (°) | 4.6 (8.0) | 2.3 (8.9) | +2.2 (-3.4, 7.8) | 0.43 | 0.35 |
| Stretch angle soleus (°) | 3.3 (10.7) | 2.6 (8.5) | +0.7 (-5.7, 7.0) | 0.83 | 0.88 |
| Outcome measure . | Active Training Within subject change, T6-T0, Mean (SD) . | Attention Control Within subject change, T6-T0, Mean (SD) . | Between-group (AT vs. AC), within subject difference, T6- T0, Mean (95% CI) . | P value for interaction between treatment group and time . | P value, age and sex adjusted . |
|---|---|---|---|---|---|
| VEINES-QOL score | 6.0 (5.1) | 1.4 (7.2) | +4.6 (0.54, 8.7) | 0.027 | 0.052 |
| SF-36 Physical Component Score | 5.6 (7.7) | 0.2 (7.6) | +5.4 (0.5, 10.4) | 0.03 | 0.09 |
| Villalta score | -3.6 (3.7) | -1.6 (4.3) | -2.0 (-4.6, 0.6) | 0.14 | 0.12 |
| Number heel lifts | 5.2 (10.6) | -2.5 (10.6) | +7.7 (0.7, 14.7) | 0.03 | 0.04 |
| Stretch angle quadriceps (°) | 10.2 (20.5) | 0.3 (6.6) | +9.9 (-1.0, 20.7) | 0.04 | 0.04 |
| Stretch angle hamstring (°) | 2.7 (11.0) | -3.7 (22.7) | +6.4 (-5.8, 18.5) | 0.29 | 0.47 |
| Stretch angle gastroc (°) | 4.6 (8.0) | 2.3 (8.9) | +2.2 (-3.4, 7.8) | 0.43 | 0.35 |
| Stretch angle soleus (°) | 3.3 (10.7) | 2.6 (8.5) | +0.7 (-5.7, 7.0) | 0.83 | 0.88 |
In our pilot trial, exercise training improved PTS severity, QOL, leg strength and leg flexibility in patients with PTS. Exercise training appears to be a promising modality to treat PTS, and a large, adequately powered trial is warranted. Funded by Canadian Institutes of Health Research
No relevant conflicts of interest to declare.
Author notes
Asterisk with author names denotes non-ASH members.
