Dysvascular Amputation Self-Management of Health (DASH)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Peripheral Artery Disease; Diabetes Mellitus; Amputation

Treatments: Behavioral: Walking Biobehavioral Intervention; Other: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04083456

R01NR018450 (U.S. NIH Grant/Contract)

19-0534

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Walking Biobehavioral Intervention (EXP)

Experimental group

Description:

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.

Treatment:

Behavioral: Walking Biobehavioral Intervention

Attention Control (CTL)

Active Comparator group

Description:

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).

Treatment:

Other: Attention Control