The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
35
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 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.
University of Colorado Hospital
Aurora, Colorado, United States
Physical Activity
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
Time frame: 3 months and 6 months
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Measures participant's confidence in managing symptoms of chronic disease. Higher scores indicate greater confidence in symptom management. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Time frame: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Measures participant's confidence in managing daily activities. Higher scores indicate greater confidence in managing daily activities. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Time frame: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Measures participant's ability to participate in social roles and activities. Higher scores indicate more ability to participate. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale."
Time frame: Day 0, 3 months, 6 months and 12 months
Prosthesis Evaluation Questionnaire - Mobility Score
Self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)
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Time frame: Day 0, 3 months, 6 months and 12 months
Timed Up-and-Go Test
Time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.
Time frame: Day 0, 3 months, 6 months and 12 months
World Health Organization-Disability Assessment Schedule 2.0
Self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).
Time frame: Day 0, 3 months, 6 months and 12 months
Self-Efficacy for Managing Chronic Disease
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).
Time frame: Day 0, 3 months, 6 months and 12 months