PABC: Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02738086
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation; Diabetes Mellitus, Type 2; Peripheral Artery Disease	Behavioral: Physical Activity Behavior Change (PABC); Behavioral: Physical Activity Behavior Change (PABC)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Feb 22, 2019
• Actual Study Completion Date: Feb 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: 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
Experimental: 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.	Behavioral: 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.; Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Retention Rate [3 months]

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

2. 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.

3. 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.

4. 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 Outcome Measures

1. 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.

2. 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.

3. Accelerometer-Based Physical Activity [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.

4. Late Life Function and Disability Scale, Frequency [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.

5. 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.

6. Late Life Function and Disability Scale, Limitation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Cory L. Christiansen, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 9, 2015
• Informed Consent Form - Dec 21, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02738086
• Other Study ID Numbers: F2054-P
• First Posted: Apr 14, 2016
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Amputation; Physical Activity; Rehabilitation
• Additional relevant MeSH terms: Peripheral Arterial Disease; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Early PABC Intervention (Months 1-3)	Wait-List Control Intervention (Months 4-6)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	16	15
COMPLETED	14	13
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Early PABC Intervention	Wait-List Control Intervention	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	16	15	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.9 (6.2)	63.4 (8.9)	65.7 (7.6)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	16 100%	15 100%	31 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	2 13.3%	3 9.7%
Not Hispanic or Latino	15 93.8%	13 86.7%	28 90.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 6.3%	1 6.7%	2 6.5%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 18.8%	0 0%	3 9.7%
White	12 75%	14 93.3%	26 83.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	16 100%	15 100%	31 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27 (5)	31 (6)	29 (6)
Time Since Amputation (months) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	37 (41)	36 (16)	36 (31)
Level of Amputation (Count of Participants)
Transtibial	14 87.5%	12 80%	26 83.9%
Transfemoral	2 12.5%	3 20%	5 16.1%
Geriatric Depression Scale score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.1 (4.0)	3.7 (3.8)	3.9 (3.9)
Mini-Mental Status Examination score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.4 (4.5)	29.0 (1.6)	28.7 (3.1)
Chakrabarty Grade score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	84.8 (18.4)	85.7 (12.4)	85.2 (15.4)
Functional Comorbidity Index score (Number of Comorbidities) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of Comorbidities]	6.8 (3.3)	6.0 (3.2)	6.4 (3.3)

Outcome Measures

1. Primary Outcome

Title	Retention Rate
Description	Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	16	15
Count of Participants [Participants]	14 87.5%	13 86.7%

2. Primary Outcome

Title	Dose Goal Attainment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PABC Intervention
Arm/Group Description	Groups 1 and 2 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.
Measure Participants	29
Count of Participants [Participants]	3 18.8%

3. Primary Outcome

Title	Acceptability
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PABC Intervention
Arm/Group Description	Groups 1 and 2 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.
Measure Participants	29
Mean (Standard Deviation) [score on a scale]	5.8 (0.8)

4. Primary Outcome

Title	Study-Related Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	16	15
Number [Adverse Events]	20	29

5. Secondary Outcome

Title	Accelerometer-Based Physical Activity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	14	13
Mean (95% Confidence Interval) [Steps]	1609	1897

6. Secondary Outcome

Title	Late Life Function and Disability Scale, Frequency
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (95% Confidence Interval) [score on a scale]	49.3	54.5

7. Secondary Outcome

Title	Accelerometer-Based Physical Activity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	14	13
Mean (95% Confidence Interval) [Steps]	1716	1773

8. Secondary Outcome

Title	Late Life Function and Disability Scale, Frequency
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	14	13
Mean (95% Confidence Interval) [score on a scale]	52.5	51.3

9. Secondary Outcome

Title	Late Life Function and Disability Scale, Limitation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (95% Confidence Interval) [score on a scale]	71.4	68.1

10. Secondary Outcome

Title	Late Life Function and Disability Scale, Limitation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early PABC Intervention	GROUP 2: Wait-List Control Intervention
Arm/Group Description	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.	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.
Measure Participants	14	13
Mean (95% Confidence Interval) [score on a scale]	74.3	68.6

Adverse Events

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.
Arm/Group Title	GROUP 1: Early PABC Intervention (Months 1-3)		GROUP 1: No Contact Phase (Months 4-6)		GROUP 2: PABC Attention Control (Months 1-3)		GROUP 2: PABC Intervention (Months 4-6)
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	GROUP 1: Early PABC Intervention (Months 1-3)		GROUP 1: No Contact Phase (Months 4-6)		GROUP 2: PABC Attention Control (Months 1-3)		GROUP 2: PABC Intervention (Months 4-6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/15 (0%)		0/15 (0%)
Serious Adverse Events
	GROUP 1: Early PABC Intervention (Months 1-3)		GROUP 1: No Contact Phase (Months 4-6)		GROUP 2: PABC Attention Control (Months 1-3)		GROUP 2: PABC Intervention (Months 4-6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		2/16 (12.5%)		1/15 (6.7%)		0/15 (0%)
Cardiac disorders
Cardiac Disorder - Other	1/16 (6.3%)	1	1/16 (6.3%)	1	0/15 (0%)	0	0/15 (0%)	0
Psychiatric disorders
Suicidal Ideation	0/16 (0%)	0	1/16 (6.3%)	1	0/15 (0%)	0	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Non-Healing Wounds	0/16 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	GROUP 1: Early PABC Intervention (Months 1-3)		GROUP 1: No Contact Phase (Months 4-6)		GROUP 2: PABC Attention Control (Months 1-3)		GROUP 2: PABC Intervention (Months 4-6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/16 (50%)		5/16 (31.3%)		8/15 (53.3%)		7/15 (46.7%)
Injury, poisoning and procedural complications
Fall	4/16 (25%)	4	2/16 (12.5%)	2	5/15 (33.3%)	5	3/15 (20%)	3
Skin and subcutaneous tissue disorders
Wound	7/16 (43.8%)	8	3/16 (18.8%)	3	5/15 (33.3%)	5	6/15 (40%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.