Dysvascular Amputation Self-Management of Health

Phase 2

Completed

• Conditions: Diabetes Mellitus; Amputation; Peripheral Artery Disease

• Registration Number: NCT04083456
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Study Start: 2019-11-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical Activity	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 Outcome Measures

Name	Time	Method
PROMIS: Ability to participate in social roles and activities	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).
Timed Up-and-Go test	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.
World Health Organization-Disability Assessment Schedule 2.0	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).
Self-Efficacy for Managing Chronic Disease	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).
Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms	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).
PROMIS: Self-Efficacy for Managing Daily Activities	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).
Prosthesis Evaluation Questionnaire - Mobility Score	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)

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States