Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial

Abstract

Objective: To determine preliminary efficacy of a home-based behavior-change intervention designed to promote exercise, walking activity, and disease self-management.

Design: A single-blind, randomized controlled pilot trial.

Setting: One Veterans Administration and 2 regional medical centers.

Participants: A total of 38 participants randomized to behavior-change intervention (n=19) or attention control (CTL; n=19) group.

Interventions: Weekly 30-minute telephone sessions for 12 weeks with intervention group sessions focused on health behavior change and CTL group sessions focused on health status monitoring.

Main outcome measures: Physical function, walking activity (steps/d averaged over 10d), and disability were measured at baseline, 12 weeks (intervention end), and 24 weeks after baseline with the Timed Up and Go (TUG) test as the primary outcome measure.

Results: The TUG test was not changed from baseline in either group and was not different between groups after 12 or 24 weeks. Several exploratory outcomes were assessed, including daily step count, which increased 1135 steps per day in the intervention group compared to 144 steps per day in the CTL group after 12 weeks (P=.03). Only the intervention group had within-group increase in steps per day from baseline to 12 (P<.001) and 24 (P=.03) weeks and spent significantly less time in sedentary activity (4.8% decrease) than the CTL group (0.2% decrease) at 24 weeks (P=.04). There were no other between-group differences in physical function or disability change over time.

Conclusion: The behavior-change intervention demonstrates promise for increasing walking activity for people with dysvascular transtibial amputation (TTA). The efficacy of implementing such intervention in the scope of conventional TTA rehabilitation should be further studied.

Trial registration: ClinicalTrials.gov NCT01929018.

Keywords: Amputation; Exercise; Rehabilitation; Walking.