Abstract 3984

Poster Board III-920

Background

Exercise training is an effective treatment for lower limb arterial claudication and may also have the potential to improve the post-thrombotic syndrome (PTS).

Objectives

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.

Methods

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.

Results

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 measureActive 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 timeP 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 measureActive 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 timeP 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 
Conclusion

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

Disclosures:

No relevant conflicts of interest to declare.

Author notes

*

Asterisk with author names denotes non-ASH members.

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