Vascular DiseasesNCT04335695
Standardized Vascular Rehabilitation Program to Improve Patient Disease and Quality of Life
A study testing Vascular Rehabilitation in people with Vascular Diseases and Peripheral Artery Disease, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to identify the type of patients being referred for the Vascular Rehabilitation Program (VRP) and to study the success rates of the program according to improvements in walking distance and quality of life surveys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Peripheral Artery Disease, Peripheral Vascular Diseases
- What is being tested?
- Vascular Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the vascular rehabilitation program at The Heart Hospital Cardiac Rehabilitation Facility.
- Female or male patients ≥18 years of age.
- Patient must be accessible for treatment and follow-up.
- Agrees to wear the activity tracker wrist-worn device
- Agrees to the follow-up QOL survey schedule
- Agrees to the follow-up ABI schedule
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
Who cannot join
- Declines participation in the study.
- Has a life-expectancy less than 18 months.
- Unable to complete necessary study follow-up procedures.
- Unwilling to wear the wrist-worn activity tracker device.
- Women who are pregnant.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
Show all 11Show fewer
- severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- home oxygen
- neurologic or orthopedic conditions limiting ability to appropriately comply with rehabilitation program.
- class III or class IV NY class congestive heart failure
- Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Heart Hospital- Plano
Plano, Texas, 75093
About this study
The purpose of this study is to identify the type of patients being referred for the Vascular Rehabilitation Program (VRP) and to study the success rates of the program according to improvements in walking distance and quality of life surveys. Subjects will be in the VRP for 6-12 weeks and then be followed for 12 months after they complete the program. This is a single-site study at Baylor Scott \& White Heart Hospital-Plano.
Read the detailed description
Peripheral arterial occlusive disease (PAOD) affects 8.5 million people in the United States. One of the most common symptoms of PAOD is claudication. While there are surgical and endovascular treatments to address the underlying arterial occlusions and relieve patients from their symptoms, the initial and primary treatment of vasculogenic claudication is exercise. Numerous studies have documented the success rates of conservative management in the short and long term. However, the main barriers to the use and success of this treatment have been physician reluctance to prescribe and supervise and lack of enthusiasm by the patients. Furthermore, unlike cardiac rehabilitation, supervised rehabilitation and therapy was not a covered benefit for patients until recently.
Beginning in 2018, Centers for Medicare Services (CMS) mandated coverage for supervised therapy for vasculogenic claudication. In 2019, a vascular rehabilitation program was established at The Heart Hospital Plano. As healthcare moves from a fee-for-service model to a payment-for-quality model, treatments such as this are becoming more important. It is necessary to have a better understanding of qualifying patients, the success of this treatment, and the durability and risk factors for success and failure in the real world outside of randomized trials.
This will be the first study of vascular rehabilitation as therapy for vasculogenic claudication in the community setting since this benefit was approved by CMS. It will integrate the areas of Vascular Surgery, Cardiology, Nursing and Cardiac Rehabilitation into a single collaborative project. The project also nicely aligns with the Baylor Scott\&White Healthcare System goal of population management in evaluating this lifestyle treatment as an alternative to intervention.
This is a prospective, non-randomized, observational study designed to demonstrate clinically significant benefit in patients undergoing the vascular rehabilitation program at The Heart Hospital Plano.
Informed consent will be obtained from all patients who wish to be enrolled in the study and will be asked to complete quality-of-life surveys specific for vasculogenic claudication (VascuQoL [Appendix 5] and Walking Impairment Questionnaire [Appendix 6]) at their study intake visit, study exit visit, and at 3, 6, 9, and 12 months following discharge from the rehabilitation program. The 3, 6, 9, and 12-month collection periods will be performed via phone.
Ankle brachial indices will be obtained at the time of study enrollment and again at the completion of the rehabilitation program according to standard practice.
A full medical history and relevant demographic and clinical information will be recorded in a de-identified database. This will include but not be limited to age, gender, BMI, tobacco use and medications. Appendix 1.
Walking distance until symptoms occur and total walking distance will be assessed at the study intake and study exit visits and at 3-month intervals for an additional 12 months. Assessments obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4. Appendix 2. Appendix 3.
Every patient will be given a wrist-worn activity tracker to track their daily walking habits during the time period that they are enrolled in the study. This data will be downloaded and stored in the de-identified database.
Following discharge from the vascular rehabilitation program, patients will be contacted every three-months for a year for a follow up quality-of-life survey and walking distance and claudication assessment.
- Being tested
- Vascular Rehabilitation
- Medical subject headings
- Vascular Diseases, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular RehabilitationBehavioural
Vascular rehabilitation is a supervised exercise therapy program that includes healthy lifestyle changes to help patients gain strength, energy and confidence to return to daily activities. A program of supervised exercise rehabilitation is considered a primary treatment for people with Peripheral Artery Disease and Intermittent Claudication. In addition, patients will be given a wrist-worn activity tracker and be in contact with a research coordinator every 3 months after they are discharged from the Vascular Rehab program.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Rehabilitation and Follow Up | Other | All subjects will be enrolled in a 6-12 Vascular Rehab Program (VRP) and then be followed for one year following discharge from the VRP. Receives: Behavioral: Vascular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ankle brachial indices at baseline of VRP and at the termination of VRP (6-12 weeks) (ABI range 0-2)
ABI will be obtained according to standard practice. Severe disease= <=0.4; Mild to moderate disease= 0.41-0.9; Normal= >1.0
Measured: 6-12 weeks (depending on time in the VRP)
Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175
Quality-of-life survey specific for vasculogenic claudication (VascuQoL) (Range QOL not impacted=175; QOL poorly impacted=7)
Measured: Baseline to 1 year after discharge
Changes to walking distance until symptoms of claudication at VRP enrollment, VRP discharge, and at one year post discharge
Measured: Baseline to 1 year after discharge
Changes to total walking distance at VRP enrollment, VRP discharge, and at one year post discharge
These will be obtained in the VRP at beginning of VRP and termination of VRP. These measurements will also be obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4.
Measured: 13-15 months
Secondary outcomes (2)
Determination of activity level evaluated on daily, weekly, monthly and cumulative levels
Measurement of activity (walking distance from pedometer)
Measured: Baseline to 1 year after discharge
Rate of lower extremity revascularization intervention that occurs during the study period (1 year following program discharge).
Measured: Baseline to 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start13 Dec 2019
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Why it stopped: Study not feasible-Not able to enroll the patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will enroll in the Vascular Rehab program at Baylor Scott \& White Heart Hospital and be followed for 1 year after the program ends.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William P Shutze, MD, Principal investigator, Baylor Scott & White Heart Hospital Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335695
- Sponsor's protocol ID
- 019-309
- Status last verified
- Oct 2022
- First submitted
- 30 Mar 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't plan to shared IPD outside our organization but plan to share the cumulative results of the study.
Publications
Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23.
PubMed 25721067Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
PubMed 28938901Conijn AP, Jens S, Terwee CB, Breek JC, Koelemay MJ. Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):316-34. doi: 10.1016/j.ejvs.2014.12.002. Epub 2015 Jan 22.
PubMed 25618453Conijn AP, Loukachov VV, Bipat S, Koelemay MJ. Test-retest Reliability and Measurement Error Are Excellent for the Dutch Version of the VascuQol Questionnaire in Patients with Intermittent Claudication. Eur J Vasc Endovasc Surg. 2015 Oct;50(4):502-5. doi: 10.1016/j.ejvs.2015.07.007. Epub 2015 Aug 8.
PubMed 26264883Conijn AP, Jonkers W, Rouwet EV, Vahl AC, Reekers JA, Koelemay MJ. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication. Cardiovasc Intervent Radiol. 2015 Oct;38(5):1112-8. doi: 10.1007/s00270-015-1060-0. Epub 2015 Mar 14.
PubMed 25772399
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Vascular Rehabilitation Program to Improve Patient Disease and Quality of Life
- ClinicalTrials.gov ID
- NCT04335695
- Acronym / sponsor ID
- 019-309
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study not feasible-Not able to enroll the patient population
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the type of patients being referred for the Vascular Rehabilitation Program (VRP) and to study the success rates of the program according to improvements in walking distance and quality of life surveys. Subjects will be in the VRP for 6-12 weeks and then be followed for 12 months after they complete the program. This is a single-site study at Baylor Scott \& White Heart Hospital-Plano.
Detailed description
Peripheral arterial occlusive disease (PAOD) affects 8.5 million people in the United States. One of the most common symptoms of PAOD is claudication. While there are surgical and endovascular treatments to address the underlying arterial occlusions and relieve patients from their symptoms, the initial and primary treatment of vasculogenic claudication is exercise. Numerous studies have documented the success rates of conservative management in the short and long term. However, the main barriers to the use and success of this treatment have been physician reluctance to prescribe and supervise and lack of enthusiasm by the patients. Furthermore, unlike cardiac rehabilitation, supervised rehabilitation and therapy was not a covered benefit for patients until recently.
Beginning in 2018, Centers for Medicare Services (CMS) mandated coverage for supervised therapy for vasculogenic claudication. In 2019, a vascular rehabilitation program was established at The Heart Hospital Plano. As healthcare moves from a fee-for-service model to a payment-for-quality model, treatments such as this are becoming more important. It is necessary to have a better understanding of qualifying patients, the success of this treatment, and the durability and risk factors for success and failure in the real world outside of randomized trials.
This will be the first study of vascular rehabilitation as therapy for vasculogenic claudication in the community setting since this benefit was approved by CMS. It will integrate the areas of Vascular Surgery, Cardiology, Nursing and Cardiac Rehabilitation into a single collaborative project. The project also nicely aligns with the Baylor Scott\&White Healthcare System goal of population management in evaluating this lifestyle treatment as an alternative to intervention.
This is a prospective, non-randomized, observational study designed to demonstrate clinically significant benefit in patients undergoing the vascular rehabilitation program at The Heart Hospital Plano.
Informed consent will be obtained from all patients who wish to be enrolled in the study and will be asked to complete quality-of-life surveys specific for vasculogenic claudication (VascuQoL [Appendix 5] and Walking Impairment Questionnaire [Appendix 6]) at their study intake visit, study exit visit, and at 3, 6, 9, and 12 months following discharge from the rehabilitation program. The 3, 6, 9, and 12-month collection periods will be performed via phone.
Ankle brachial indices will be obtained at the time of study enrollment and again at the completion of the rehabilitation program according to standard practice.
A full medical history and relevant demographic and clinical information will be recorded in a de-identified database. This will include but not be limited to age, gender, BMI, tobacco use and medications. Appendix 1.
Walking distance until symptoms occur and total walking distance will be assessed at the study intake and study exit visits and at 3-month intervals for an additional 12 months. Assessments obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4. Appendix 2. Appendix 3.
Every patient will be given a wrist-worn activity tracker to track their daily walking habits during the time period that they are enrolled in the study. This data will be downloaded and stored in the de-identified database.
Following discharge from the vascular rehabilitation program, patients will be contacted every three-months for a year for a follow up quality-of-life survey and walking distance and claudication assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will enroll in the Vascular Rehab program at Baylor Scott \& White Heart Hospital and be followed for 1 year after the program ends.
| Arm | Type | Receives |
|---|---|---|
| Vascular Rehabilitation and Follow Up | Other | Behavioral: Vascular RehabilitationAll subjects will be enrolled in a 6-12 Vascular Rehab Program (VRP) and then be followed for one year following discharge from the VRP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled in the vascular rehabilitation program at The Heart Hospital Cardiac Rehabilitation Facility.
- Female or male patients ≥18 years of age.
- Patient must be accessible for treatment and follow-up.
- Agrees to wear the activity tracker wrist-worn device
- Agrees to the follow-up QOL survey schedule
Key exclusion criteria (11 listed)
- Declines participation in the study.
- Has a life-expectancy less than 18 months.
- Unable to complete necessary study follow-up procedures.
- Unwilling to wear the wrist-worn activity tracker device.
- Women who are pregnant.
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 |
|---|---|---|
| Vascular RehabilitationVascular rehabilitation is a supervised exercise therapy program that includes healthy lifestyle changes to help patients gain strength, energy and confidence to return to daily activities. A program of supervised exercise rehabilitation is considered a primary treatment for people with Peripheral Artery Disease and Intermittent Claudication. In addition, patients will be given a wrist-worn activity tracker and be in contact with a research coordinator every 3 months after they are discharged from the Vascular Rehab program. | Behavioural | Vascular Rehabilitation and Follow Up |
Primary outcome
Changes in ankle brachial indices at baseline of VRP and at the termination of VRP (6-12 weeks) (ABI range 0-2)
Time frame: 6-12 weeks (depending on time in the VRP)
ABI will be obtained according to standard practice. Severe disease= <=0.4; Mild to moderate disease= 0.41-0.9; Normal= >1.0
Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175
Time frame: Baseline to 1 year after discharge
Quality-of-life survey specific for vasculogenic claudication (VascuQoL) (Range QOL not impacted=175; QOL poorly impacted=7)
Changes to walking distance until symptoms of claudication at VRP enrollment, VRP discharge, and at one year post discharge
Time frame: Baseline to 1 year after discharge
Changes to total walking distance at VRP enrollment, VRP discharge, and at one year post discharge
Time frame: 13-15 months
These will be obtained in the VRP at beginning of VRP and termination of VRP. These measurements will also be obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4.
2 secondary outcomes
Determination of activity level evaluated on daily, weekly, monthly and cumulative levels
Time frame: Baseline to 1 year after discharge
Rate of lower extremity revascularization intervention that occurs during the study period (1 year following program discharge).
Time frame: Baseline to 1 year after discharge
Results and safety
The study was stopped early (reason given: Study not feasible-Not able to enroll the patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 25721067Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23.
- Background: PubMed 28938901Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
- Background: PubMed 25618453Conijn AP, Jens S, Terwee CB, Breek JC, Koelemay MJ. Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):316-34. doi: 10.1016/j.ejvs.2014.12.002. Epub 2015 Jan 22.
- Background: PubMed 26264883Conijn AP, Loukachov VV, Bipat S, Koelemay MJ. Test-retest Reliability and Measurement Error Are Excellent for the Dutch Version of the VascuQol Questionnaire in Patients with Intermittent Claudication. Eur J Vasc Endovasc Surg. 2015 Oct;50(4):502-5. doi: 10.1016/j.ejvs.2015.07.007. Epub 2015 Aug 8.
- Background: PubMed 25772399Conijn AP, Jonkers W, Rouwet EV, Vahl AC, Reekers JA, Koelemay MJ. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication. Cardiovasc Intervent Radiol. 2015 Oct;38(5):1112-8. doi: 10.1007/s00270-015-1060-0. Epub 2015 Mar 14.
- Individual participant dataSharing planned: No. We don't plan to shared IPD outside our organization but plan to share the cumulative results of the study.
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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.
William P Shutze, MD principal investigator
Baylor Scott & White Heart Hospital Plano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Rehabilitation in people with Vascular Diseases and Peripheral Artery Disease, run by Baylor Research Institute 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Oct 2022. 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?
The study was stopped early (reason given: Study not feasible-Not able to enroll the patient population). Results are not available in the source record.
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?
Changes in ankle brachial indices at baseline of VRP and at the termination of VRP (6-12 weeks) (ABI range 0-2) (time frame: 6-12 weeks (depending on time in the VRP)). 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 NCT04335695, which also lists 5 linked publications.
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 Oct 2022.