Feasibility randomized controlled trial of remotely supervised exercise versus self-directed exercise for intermittent claudication

Background: This trial examined the feasibility of a future trial of remotely supervised exercise (RSE) versus self-directed exercise (SDE) for stable claudication.

Methods: Randomized, single center, assessor blind, feasibility trial. In the intervention arm patients received fortnightly video or telephone calls from a physiotherapist with a tailored exercise prescription and review of progress with the aim of a minimum of 120 min of leg exercise per week. In the comparator arm, patients were asked to do this themselves. Both groups had an electronic walking log which was inspected at 3 and 6 months. The primary endpoint was maximum walking distance recorded by a blinded assessor. As this was a feasibility study the randomization target was 40 patients.

Results: 44 patients were randomized over a 2 year period. The eligibility rate was 57% of those screened. The participation rate was 100% of those eligible. The withdrawal rate was 27% of those randomized. Maximum walking distance improved, on average, by +369m in the remotely supervised group and by +322m in the SDE group. Quality of life gains were similar in both arms.

Conclusion: A large randomized controlled trial comparing RSE with SDE would be difficult using this protocol, because of the high withdrawal rate and small treatment effect.