AmputationPABCNCT02738086

Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

A study testing Physical Activity Behavior Change (PABC) in people with Amputation and Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease
What is being tested?: Physical Activity Behavior Change (PABC)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2016to 22 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Traumatic or cancer-related etiology of the lower limb amputation
Unstable heart condition, including:
unstable angina
uncontrolled cardiac dysrhythmia
acute myocarditis
acute pericarditis

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation

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.

Read the 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:

participant retention
dose goal attainment
participant acceptability
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.

Conditions: Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease
Being tested: Physical Activity Behavior Change (PABC)
Keywords: Amputation, Physical Activity, Rehabilitation
Medical subject headings: Diabetes Mellitus, Type 2, Peripheral Arterial Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical Activity Behavior Change (PABC)Behavioural
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.
Physical Activity Behavior Change (PABC)Behavioural
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

Study groups in NCT02738086
Study group	Role	What they receive
Early PABC Intervention	Experimental	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. Receives: Behavioral: Physical Activity Behavior Change (PABC)
Wait-List Control Intervention	Experimental	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. Receives: Behavioral: Physical Activity Behavior Change (PABC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention Rate
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months

Secondary outcomes (6)

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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 3 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201622 Feb 2019

First posted14 Apr 2016 (estimated)
Study start1 Jul 2016
Primary completion22 Feb 2019
Study completion22 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AmputationStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738086
Sponsor's protocol ID: F2054-P
Acronym: PABC
Status last verified: Feb 2020
First submitted: 16 Mar 2016
Last updated: 18 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Christiansen CL, Miller MJ, Kline PW, Fields TT, Sullivan WJ, Blatchford PJ, Stevens-Lapsley JE. Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial. PM R. 2020 Oct;12(10):957-966. doi: 10.1002/pmrj.12374. Epub 2020 May 6.
PubMed 32248638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
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Amputation, Surgical, Pain Management

All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
ClinicalTrials.gov ID: NCT02738086
Acronym / sponsor ID: PABC / F2054-P
Conditions: Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease
Keywords: Amputation, Physical Activity, Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jul 2016 (actual)
Primary completion: 22 Feb 2019 (actual)
Study completion: 22 Feb 2019 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 18 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

participant retention
dose goal attainment
participant acceptability
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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early PABC Intervention	Experimental	Behavioral: Physical Activity Behavior Change (PABC)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.
Wait-List Control Intervention	Experimental	Behavioral: Physical Activity Behavior Change (PABC)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.

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

Traumatic or cancer-related etiology of the lower limb amputation
Unstable heart condition, including:
Uncontrolled hypertension
Acute systemic infection
Prisoner

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Early PABC Intervention, Wait-List Control Intervention
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	Behavioural	Early PABC Intervention, Wait-List Control Intervention

Primary outcome

Retention Rate
Time frame: 3 months
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Dose Goal Attainment
Time frame: 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
Time frame: 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
Time frame: 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.

6 secondary outcomes

Accelerometer-Based Physical Activity
Time frame: 3 months
Late Life Function and Disability Scale, Frequency
Time frame: 3 months
Accelerometer-Based Physical Activity
Time frame: 6 months
Late Life Function and Disability Scale, Frequency
Time frame: 6 months
Late Life Function and Disability Scale, Limitation
Time frame: 3 months
Late Life Function and Disability Scale, Limitation
Time frame: 6 months

Results and safety

Results posted to the registry on 18 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early PABC Intervention (Months 1-3)	16	14
Wait-List Control Intervention (Months 4-6)	15	13

Primary outcome: Retention Rate

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Early PABC Intervention n = 16	GROUP 2: Wait-List Control Intervention n = 15
Value	14	13

Primary outcome: Dose Goal Attainment

Time frame: 3 months. Count of participants. Unit: Participants

Measure	PABC Intervention n = 29
Value	3

Primary outcome: Acceptability

Time frame: 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	PABC Intervention n = 29
Value	5.8 (0.8)

Primary outcome: Study-Related Adverse Events

Time frame: 3 months. Number. Unit: Adverse Events

Measure	Early PABC Intervention n = 16	GROUP 2: Wait-List Control Intervention n = 15
Value	20	29

6 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GROUP 1: Early PABC Intervention (Months 1-3)	1 of 16 (6.3%)	8 of 16 (50%)	0 of 16
GROUP 1: No Contact Phase (Months 4-6)	2 of 16 (12.5%)	5 of 16 (31.3%)	0 of 16
GROUP 2: PABC Attention Control (Months 1-3)	1 of 15 (6.7%)	8 of 15 (53.3%)	0 of 15
GROUP 2: PABC Intervention (Months 4-6)	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32248638Christiansen CL, Miller MJ, Kline PW, Fields TT, Sullivan WJ, Blatchford PJ, Stevens-Lapsley JE. Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial. PM R. 2020 Oct;12(10):957-966. doi: 10.1002/pmrj.12374. Epub 2020 May 6.
Individual participant dataSharing planned: No

Related trials for Amputation

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cory L. Christiansen, PhD principal investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Behavior Change (PABC) in people with Amputation and Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention Rate (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.