Amputation, Diabetes Mellitus, Peripheral Artery Disease
Conditions
Keywords
Amputation, Dysvascular Amputation, Diabetes, Peripheral Artery Disease, Physical Activity
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.
Interventions
BEHAVIORALWalking Biobehavioral Intervention
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.
OTHERAttention Control
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.
Sponsors
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled futility design
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 3 months and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms | Day 0, 3 months, 6 months and 12 months | 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. |
| Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities | Day 0, 3 months, 6 months and 12 months | 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. |
| Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities | Day 0, 3 months, 6 months and 12 months | 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." |
| Prosthesis Evaluation Questionnaire - Mobility Score | Day 0, 3 months, 6 months and 12 months | Self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility) |
| Timed Up-and-Go Test | Day 0, 3 months, 6 months and 12 months | 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 | 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 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCory Christiansen, PT, PhD
University of Colorado, Denver
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 |
| Amputation level transfemoral or knee disarticulation | 6 Participants |
| Amputation level transtibial | 15 Participants |
| Daily step count | 1066 steps per day STANDARD_DEVIATION 1099 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized African-American | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants |
| Race/Ethnicity, Customized multiracial | 1 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 2 / 17 |
| other Total, other adverse events | 16 / 18 | 13 / 17 |
| serious Total, serious adverse events | 8 / 18 | 8 / 17 |
Outcome results
None listed