Dysvascular Amputation Self-Management of Health

NCT04083456 | Completed Phase 2

• 2 other identifiers: 19-0534R01NR018450
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation; Diabetes Mellitus; Peripheral Artery Disease

Keywords

Amputation; Dysvascular Amputation; Diabetes; Peripheral Artery Disease; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Change in 10 day physical activity step count with ActivPAL activity monitor between the beginning of conventional prosthetic rehabilitation to the end of intervention. Maintenance will be observed at six months after the end of the intervention.

  Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months)

Secondary Outcomes (7)

• Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms

  Day 0, 3 months, 6 months and 12 months

• PROMIS: Self-Efficacy for Managing Daily Activities

  Day 0, 3 months, 6 months and 12 months

• PROMIS: Ability to participate in social roles and activities

  Day 0, 3 months, 6 months and 12 months

• Prosthesis Evaluation Questionnaire - Mobility Score

  Day 0, 3 months, 6 months and 12 months

• Timed Up-and-Go test

  Day 0, 3 months, 6 months and 12 months

Other Outcomes (7)

• Activities-specific Balance Confidence Scale

  Day 0, 3 months, 6 months and 12 months

• Two-Minute Walk Test

  Day 0, 3 months, 6 months and 12 months

• Five Meter Walk

  Day 0, 3 months, 6 months and 12 months

Study Arms (2)

Walking Biobehavioral Intervention (EXP)

EXPERIMENTAL

The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.

Behavioral: Walking Biobehavioral Intervention

Attention Control (CTL)

ACTIVE COMPARATOR

The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).

Other: Attention Control

Interventions

Walking Biobehavioral Intervention BEHAVIORAL

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.

Walking Biobehavioral Intervention (EXP)

Attention Control OTHER

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.

Attention Control (CTL)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within the age range of 50-85 years
• Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
• Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
• Participant goal of household walking or better using a prosthesis

You may not qualify if:

• Trauma or cancer-related etiology of the LLA
• Decisionally challenged individuals (MMSE score below 24)
• Prisoners
• Active cancer treatment
• Recent stroke (within 2 years)
• Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

  PMID: 37276273 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• Cory Christiansen, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled futility design

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 10, 2019
• Study Start: November 1, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: The investigators will publish the trial results within one year of testing the final participant.
• Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with NIH Data Sharing Policy Guidelines.

Locations

US (1)