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Completed

NCT Number: NCT04083456

Dysvascular Amputation Self-Management of Health

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

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Key information

Conditions

Amputation Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Physical Activity

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

    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.

Secondary outcomes

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

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in participant's confidence in managing symptoms of chronic disease. Final scores range from 4 points (not at all confident) to 20 points (very confident).

  2. PROMIS: Self-Efficacy for Managing Daily Activities

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in participant's confidence in managing daily activities. Final scores range from 4 points (not at all confident) to 20 points (very confident).

  3. PROMIS: Ability to participate in social roles and activities

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in participant's ability to participate in social roles and activities. Final scores range from 8 points (never participates) to 40 points (always participates).

  4. Prosthesis Evaluation Questionnaire - Mobility Score

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)

  5. Timed Up-and-Go test

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.

  6. World Health Organization-Disability Assessment Schedule 2.0

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).

  7. Self-Efficacy for Managing Chronic Disease

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in self-reported confidence in managing different aspects of chronic disease. Final scores range from 1 (not at all confident in managing chronic disease) to 10 (totally confident in managing chronic disease).

Other outcomes

  1. Activities-specific Balance Confidence Scale

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in self-reported balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).

  2. Two-Minute Walk Test

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in the distance a participant can walk in two minutes. Use of assistive device is noted

  3. Five Meter Walk

    Time frame: Day 0, 3 months, 6 months and 12 months

    Change in the length of time it takes a participant to walk 5 meters, at a comfortable walking pace.

  4. Study Intervention Reach

    Time frame: Day 0

    Percentage of eligible participants enrolled

  5. Outpatient Practitioner Intervention Fidelity

    Time frame: Day 0 through 3 months

    An individual practitioner's percent adherence to outpatient intervention protocol

  6. Biobehavioral Practitioner Intervention Fidelity

    Time frame: Day 0 through 6 months

    An individual interventionist's percent adherence to biobehavioral intervention protocol

  7. FitBit Use Adherence

    Time frame: Month 12

    Number of days participant uses FitBit during the no-contact phase of the study

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation

Acronym: DASH

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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