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
40
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
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.
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)
Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms
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).
Time frame: Day 0, 3 months, 6 months and 12 months
PROMIS: Self-Efficacy for Managing Daily Activities
Change in participant's confidence in managing daily activities. Final scores range from 4 points (not at all confident) to 20 points (very confident).
Time frame: Day 0, 3 months, 6 months and 12 months
PROMIS: Ability to participate in social roles and activities
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).
Time frame: Day 0, 3 months, 6 months and 12 months
Prosthesis Evaluation Questionnaire - Mobility Score
Change in self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)
Time frame: Day 0, 3 months, 6 months and 12 months
Timed Up-and-Go test
Change in time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.
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Time frame: Day 0, 3 months, 6 months and 12 months
World Health Organization-Disability Assessment Schedule 2.0
Change in 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
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).
Time frame: Day 0, 3 months, 6 months and 12 months