NCT02738086: PABC

Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

Completed NA Results posted Last updated 18 February 2020

What this trial tests

NA trial testing Physical Activity Behavior Change (PABC) in Amputation in 31 participants. Completed in 22 February 2019.

Timeline

1 July 2016

Primary endpoint
22 February 2019

22 February 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	1 July 2016
Primary completion	22 February 2019
Estimated completion	22 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Physical Activity Behavior Change (PABC)
• Physical Activity Behavior Change (PABC)

Conditions studied

• Amputation — all drugs for Amputation →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 50 to 85, any sex, with Amputation or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Rate Primary · 3 months

Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.

Group	Value	95% CI
Early PABC Intervention	14
GROUP 2: Wait-List Control Intervention	13

Dose Goal Attainment Primary · 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.

Group	Value	95% CI
PABC Intervention	3

Acceptability Primary · 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.

Group	Value	95% CI
PABC Intervention	5.8	± 0.8

Study-Related Adverse Events Primary · 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.

Group	Value	95% CI
Early PABC Intervention	20
GROUP 2: Wait-List Control Intervention	29

Accelerometer-Based Physical Activity Secondary · 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.

Group	Value	95% CI
Early PABC Intervention	1609	826 – 2393
GROUP 2: Wait-List Control Intervention	1897	1242 – 2551

Late Life Function and Disability Scale, Frequency Secondary · 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.

Group	Value	95% CI
Early PABC Intervention	49.3	46.2 – 52.4
GROUP 2: Wait-List Control Intervention	54.5	48.5 – 60.6

Accelerometer-Based Physical Activity Secondary · 6 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.

Group	Value	95% CI
Early PABC Intervention	1716	948 – 2483
GROUP 2: Wait-List Control Intervention	1773	1189 – 2357

Late Life Function and Disability Scale, Frequency Secondary · 6 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.

Group	Value	95% CI
Early PABC Intervention	52.5	48.6 – 56.3
GROUP 2: Wait-List Control Intervention	51.3	48.4 – 54.3

Late Life Function and Disability Scale, Limitation Secondary · 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.

Group	Value	95% CI
Early PABC Intervention	71.4	63.2 – 79.7
GROUP 2: Wait-List Control Intervention	68.1	55.3 – 80.9

Late Life Function and Disability Scale, Limitation Secondary · 6 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.

Group	Value	95% CI
Early PABC Intervention	74.3	65.3 – 83.3
GROUP 2: Wait-List Control Intervention	68.6	60.7 – 76.4

Adverse events — posted to ClinicalTrials.gov

Time frame: For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GROUP 1: Early PABC Intervention (Months 1-3)

Serious: 1/16 (6%)

Deaths: 0/16

GROUP 1: No Contact Phase (Months 4-6)

Serious: 2/16 (13%)

Deaths: 0/16

GROUP 2: PABC Attention Control (Months 1-3)

Serious: 1/15 (7%)

Deaths: 0/15

GROUP 2: PABC Intervention (Months 4-6)

Serious: 0/15 (0%)

Deaths: 0/15

Serious adverse events (3 terms)

Reaction	System	GROUP 1: Early PABC Interv…	GROUP 1: No Contact Phase …	GROUP 2: PABC Attention Co…	GROUP 2: PABC Intervention…
Cardiac Disorder - Other	Cardiac disorders	—	—	—	—
Non-Healing Wounds	Skin and subcutaneous tissue disorders	—	—	—	—
Suicidal Ideation	Psychiatric disorders	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	GROUP 1: Early PABC Interv…	GROUP 1: No Contact Phase …	GROUP 2: PABC Attention Co…	GROUP 2: PABC Intervention…
Wound	Skin and subcutaneous tissue disorders	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—

Most-reported serious reactions: Cardiac Disorder - Other, Non-Healing Wounds, Suicidal Ideation.

Data from ClinicalTrials.gov NCT02738086 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Falls After Dysvascular Transtibial Amputation: A Secondary Analysis of Falling Characteristics and Reduced Physical Performance.
   Anderson CB, Miller MJ, Murray AM, Fields TT, et al · · 2021 · cited 22× · PMID 32249517 · DOI 10.1002/pmrj.12376
2. Physical Function and Pre-Amputation Characteristics Explain Daily Step Count after Dysvascular Amputation.
   Miller MJ, Cook PF, Kline PW, Anderson CB, et al · · 2019 · cited 17× · PMID 30729727 · DOI 10.1002/pmrj.12121
3. Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial.
   Christiansen CL, Christiansen CL, Miller MJ, Kline PW, et al · · 2020 · cited 13× · PMID 32248638 · DOI 10.1002/pmrj.12374