Dysvascular Amputation Self-Management of Health
- Conditions
- Diabetes MellitusAmputationPeripheral Artery Disease
- Interventions
- Behavioral: Walking Biobehavioral InterventionOther: Attention Control
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
- Arm && Interventions
Group Intervention Description Walking Biobehavioral Intervention (EXP) Walking Biobehavioral Intervention 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. Attention Control (CTL) Attention Control 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).
- 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