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Dysvascular Amputation Self-Management of Health

NCT04083456 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-29

No results posted yet for this study

Summary

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Conditions

Interventions

BEHAVIORAL

Walking Biobehavioral Intervention

Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.

OTHER

Attention Control

Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Cory Christiansen, PT, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083456 on ClinicalTrials.gov