Diabetes ComplicationsNCT01929018
Collaborative-care Rehabilitation After Dysvascular Amputation
A study testing Exercise, Walking Program and Health Self-Management Support in people with Diabetes Complications and Peripheral Arterial Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetes Complications, Peripheral Arterial Disease
- What is being tested?
- Exercise, Walking Program and Health Self-Management Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2013to 29 Jun 2017
- 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
- Diabetes and/or Peripheral Artery Disease
- Unilateral transtibial amputation < 6 months prior to screening
- Household ambulation using definitive prosthesis prior to baseline testing
- Participation in physical rehabilitation at time of baseline testing
- Live within 45 minutes of a participating clinic
Who cannot join
- Require wheelchair for mobility (use prosthesis for transfers only)
- Ankle-level or above amputation on contralateral limb
- Traumatic or cancer-related amputation
- Uncontrolled heart condition
- Acute systemic infection
- Pregnancy
- Decisionally challenged
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.
- Being tested
- Exercise, Walking Program, Health Self-Management Support
- Keywords
- Amputation, Rehabilitation, Exercise, Movement
- Medical subject headings
- Diabetes Complications, Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking ProgramBehavioural
A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management SupportBehavioural
Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Exercise, activity, and self-management | Experimental | Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions. Receives: Behavioral: Exercise; Behavioral: Walking Program; Behavioral: Health Self-Management Support |
| Home and phone visit | No intervention | No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up-and-Go Test
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
Measured: Baseline, 12-weeks, and 24 weeks
Secondary outcomes (8)
Two-Minute Walk Test
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Measured: Baseline, 12 weeks, and 24 weeks
Five Meter Walk Test
Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".
Measured: Baseline, 12 weeks, and 24 weeks
Prosthesis Evaluation Questionnaire - Mobility Section
Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.
Measured: Baseline, 12 weeks, and 24 weeks
Houghton Scale
Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.
Measured: Baseline, 12 weeks, and 24 weeks
Patient-Specific Function Scale
Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.
Measured: Baseline, 12 weeks, and 24 weeks
Physical Activity Step Counts
Instrumented physical activity measure, average step counts per day
Measured: Baseline, 12 weeks, and 24 weeks
Self-Efficacy in Managing Chronic Disease Questionnaire
Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.
Measured: Baseline, 12 weeks, and 24 weeks
World Health Organization Disability Assessment Scale
Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).
Measured: Baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study start9 Oct 2013
- Primary completion27 Mar 2017
- Study completion29 Jun 2017
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 Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cory L Christiansen, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929018
- Sponsor's protocol ID
- 13-0179
- Status last verified
- Jul 2019
- First submitted
- 19 Aug 2013
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Christiansen CL, Miller MJ, Murray AM, Stephenson RO, Stevens-Lapsley JE, Hiatt WR, Schenkman ML. Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2160-2167. doi: 10.1016/j.apmr.2018.04.011. Epub 2018 May 7.
PubMed 29746823
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
- ClinicalTrials.gov ID
- NCT01929018
- Acronym / sponsor ID
- 13-0179
- Keywords
- Amputation, Rehabilitation, Exercise, Movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise, activity, and self-management | Experimental | Behavioral: Exercise, Behavioral: Walking Program, Behavioral: Health Self-Management SupportExercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions. |
| Home and phone visit | No intervention | –No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes and/or Peripheral Artery Disease
- Unilateral transtibial amputation < 6 months prior to screening
- Household ambulation using definitive prosthesis prior to baseline testing
- Participation in physical rehabilitation at time of baseline testing
- Live within 45 minutes of a participating clinic
Key exclusion criteria (8 listed)
- Require wheelchair for mobility (use prosthesis for transfers only)
- Ankle-level or above amputation on contralateral limb
- Traumatic or cancer-related amputation
- Uncontrolled heart condition
- Acute systemic infection
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 |
|---|---|---|
| ExerciseExercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period. | Behavioural | Exercise, activity, and self-management |
| Walking ProgramA walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks. | Behavioural | Exercise, activity, and self-management |
| Health Self-Management SupportHealth self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period. | Behavioural | Exercise, activity, and self-management |
Primary outcome
Timed Up-and-Go Test
Time frame: Baseline, 12-weeks, and 24 weeks
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
8 secondary outcomes
Two-Minute Walk Test
Time frame: Baseline, 12 weeks, and 24 weeks
Five Meter Walk Test
Time frame: Baseline, 12 weeks, and 24 weeks
Prosthesis Evaluation Questionnaire - Mobility Section
Time frame: Baseline, 12 weeks, and 24 weeks
Houghton Scale
Time frame: Baseline, 12 weeks, and 24 weeks
Patient-Specific Function Scale
Time frame: Baseline, 12 weeks, and 24 weeks
Physical Activity Step Counts
Time frame: Baseline, 12 weeks, and 24 weeks
Self-Efficacy in Managing Chronic Disease Questionnaire
Time frame: Baseline, 12 weeks, and 24 weeks
World Health Organization Disability Assessment Scale
Time frame: Baseline, 12 weeks, and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29746823Christiansen CL, Miller MJ, Murray AM, Stephenson RO, Stevens-Lapsley JE, Hiatt WR, Schenkman ML. Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2160-2167. doi: 10.1016/j.apmr.2018.04.011. Epub 2018 May 7.
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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, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Walking Program and Health Self-Management Support in people with Diabetes Complications and Peripheral Arterial Disease, run by University of Colorado, Denver 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 8 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 14 Aug 2019. 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 14 Aug 2019). 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?
Timed Up-and-Go Test (time frame: Baseline, 12-weeks, and 24 weeks). 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 NCT01929018, 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 14 Aug 2019.