Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease
Conditions
Keywords
Amputation, Physical Activity, Rehabilitation
Brief summary
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
Detailed description
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring: 1. participant retention 2. dose goal attainment 3. participant acceptability 4. safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.
Interventions
BEHAVIORALPhysical Activity Behavior Change (PABC)
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Lower limb amputation 1-5 years prior to enrollment * Type 2 Diabetes Mellitus and/or * Peripheral Artery Disease * Ambulatory using a lower limb prosthesis * English speaking
Exclusion criteria
* Traumatic or cancer-related etiology of the lower limb amputation * Unstable heart condition, including: * unstable angina * uncontrolled cardiac dysrhythmia * acute myocarditis * acute pericarditis * Uncontrolled hypertension * Acute systemic infection * Prisoner * Decisionally challenged volunteers * Cancer * Recent cerebral vascular accident (within two years) * lower extremity wound or ulcer that limits ability to ambulate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 3 months | Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention. |
| Dose Goal Attainment | 3 months | Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps. |
| Acceptability | 3 months | Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0. |
| Study-Related Adverse Events | 3 months | Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Life Function and Disability Scale, Frequency | 3 months | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. |
| Late Life Function and Disability Scale, Limitation | 3 months | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. |
| Accelerometer-Based Physical Activity | 3 months | Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early PABC Intervention GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. | 16 |
| Wait-List Control Intervention GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Total | Early PABC Intervention | Wait-List Control Intervention |
|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 7.6 | 67.9 years STANDARD_DEVIATION 6.2 | 63.4 years STANDARD_DEVIATION 8.9 |
| BMI | 29 kg/m^2 STANDARD_DEVIATION 6 | 27 kg/m^2 STANDARD_DEVIATION 5 | 31 kg/m^2 STANDARD_DEVIATION 6 |
| Chakrabarty Grade score | 85.2 units on a scale STANDARD_DEVIATION 15.4 | 84.8 units on a scale STANDARD_DEVIATION 18.4 | 85.7 units on a scale STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 15 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Functional Comorbidity Index score | 6.4 Number of Comorbidities STANDARD_DEVIATION 3.3 | 6.8 Number of Comorbidities STANDARD_DEVIATION 3.3 | 6.0 Number of Comorbidities STANDARD_DEVIATION 3.2 |
| Geriatric Depression Scale score | 3.9 units on a scale STANDARD_DEVIATION 3.9 | 4.1 units on a scale STANDARD_DEVIATION 4 | 3.7 units on a scale STANDARD_DEVIATION 3.8 |
| Level of Amputation Transfemoral | 5 Participants | 2 Participants | 3 Participants |
| Level of Amputation Transtibial | 26 Participants | 14 Participants | 12 Participants |
| Mini-Mental Status Examination score | 28.7 units on a scale STANDARD_DEVIATION 3.1 | 28.4 units on a scale STANDARD_DEVIATION 4.5 | 29.0 units on a scale STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 12 Participants | 14 Participants |
| Region of Enrollment United States | 31 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 31 Participants | 16 Participants | 15 Participants |
| Time Since Amputation (months) | 36 months STANDARD_DEVIATION 31 | 37 months STANDARD_DEVIATION 41 | 36 months STANDARD_DEVIATION 16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 8 / 16 | 5 / 16 | 8 / 15 | 7 / 15 |
| serious Total, serious adverse events | 1 / 16 | 2 / 16 | 1 / 15 | 0 / 15 |
Outcome results
Primary
Acceptability
Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early PABC Intervention | Acceptability | 5.8 score on a scale | Standard Deviation 0.8 |
Primary
Dose Goal Attainment
Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early PABC Intervention | Dose Goal Attainment | 3 Participants |
Primary
Retention Rate
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early PABC Intervention | Retention Rate | 14 Participants |
| GROUP 2: Wait-List Control Intervention | Retention Rate | 13 Participants |
Primary
Study-Related Adverse Events
Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early PABC Intervention | Study-Related Adverse Events | 20 Adverse Events |
| GROUP 2: Wait-List Control Intervention | Study-Related Adverse Events | 29 Adverse Events |
Secondary
Accelerometer-Based Physical Activity
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Accelerometer-Based Physical Activity | 1716 Steps |
| GROUP 2: Wait-List Control Intervention | Accelerometer-Based Physical Activity | 1773 Steps |
Secondary
Accelerometer-Based Physical Activity
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Accelerometer-Based Physical Activity | 1609 Steps |
| GROUP 2: Wait-List Control Intervention | Accelerometer-Based Physical Activity | 1897 Steps |
Secondary
Late Life Function and Disability Scale, Frequency
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Late Life Function and Disability Scale, Frequency | 49.3 score on a scale |
| GROUP 2: Wait-List Control Intervention | Late Life Function and Disability Scale, Frequency | 54.5 score on a scale |
Secondary
Late Life Function and Disability Scale, Frequency
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Late Life Function and Disability Scale, Frequency | 52.5 score on a scale |
| GROUP 2: Wait-List Control Intervention | Late Life Function and Disability Scale, Frequency | 51.3 score on a scale |
Secondary
Late Life Function and Disability Scale, Limitation
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Late Life Function and Disability Scale, Limitation | 71.4 score on a scale |
| GROUP 2: Wait-List Control Intervention | Late Life Function and Disability Scale, Limitation | 68.1 score on a scale |
Secondary
Late Life Function and Disability Scale, Limitation
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early PABC Intervention | Late Life Function and Disability Scale, Limitation | 74.3 score on a scale |
| GROUP 2: Wait-List Control Intervention | Late Life Function and Disability Scale, Limitation | 68.6 score on a scale |