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

The study was a small pilot, so it had limited power to detect differences in secondary outcomes. Multiple secondary outcomes were reported without adjustment for multiple comparisons. Participants chose their own weekly goals, so exercise and functional training were not targeted equally across people. The intervention was a bundle of education, goal setting, self-monitoring, feedback, and planning, so the contribution of any single part cannot be separated. Outcome assessors were blinded, but participants and therapists were not. Two participants were lost to follow-up, and some could not complete performance measures because of illness. No direct measurement of intervention fidelity was made. Control group exercise behavior was not tracked except step count. TUG variability was higher than expected, limiting ability to identify group differences. Accelerometer activity intensity may not equal direct energy expenditure.

The work was funded by NIH grants K12 HD055931 and NIH/NCATS UL1-TR001082. Author disclosures state no previous presentation, manuscript, abstract, or conference presentation of the research.

Do not conclude that the behavior-change telephone program improves physical function or disability. The primary timed chair-to-walk test showed no difference between groups, and the step-count gain came from a small pilot with self-selected goals.