Peripheral Arterial DiseaseNCT03251391
Cardiac Rehabilitation Program in Peripheral Arterial Disease
A study testing Cardiac Rehabilitation Program and Conventional Therapy in people with Peripheral Arterial Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Cardiac Rehabilitation Program and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 11 May 2019
- 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
- Patients with PAD post-revascularization (stent, angioplasty, or bypass).
- Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.
Who cannot join
- Below or above the knee amputation.
- Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
- Unfavorable short term prognosis and limited life expectancy (<2 years)
- Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
- Prior history of having dropped out of CR without completing.
- Unwilling to consent for all aspects of CR or study participation.
- Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cardiac Rehabilitation Program, Conventional Therapy
- Keywords
- revascularization, blocked arteries, leg arteries, leg pain
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation ProgramOther
Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.
Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.
Conventional TherapyOther
Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Participants randomized to this group will undergo cardiac rehabilitation program. Receives: Other: Cardiac Rehabilitation Program |
| Control Group | Active comparator | Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk test
Results will be measured in meters.
Measured: Change from Baseline to Up to 6 Months
Secondary outcomes (6)
Short Form Health Survey 36 (SF-36)
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Measured: Change from Baseline to Up to 6 Months
Short Form Health Survey 36 (SF-36)
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Measured: Change from Baseline to Week 18
Vascular Quality of Life Questionnaire-6 (VascuQol6)
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Measured: Change from Baseline to Up to 6 Months
Vascular Quality of Life Questionnaire-6 (VascuQol6)
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Measured: Change from Baseline to Week 18
Absolute Claudication Distance (ACD)
ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
Measured: Change from Baseline to Up to 6 Months
Functional Claudication Distance (FCD)
FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.
Measured: Change from Baseline to Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start13 Apr 2017
- Primary completion11 May 2019
- Study completion11 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamal Gupta, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251391
- Sponsor's protocol ID
- STUDY00140692
- Status last verified
- Sep 2019
- First submitted
- 11 Aug 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03251391
- Acronym / sponsor ID
- STUDY00140692
- Conditions
- Peripheral Arterial Disease
- Keywords
- revascularization, blocked arteries, leg arteries, leg pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 11 May 2019 (actual)
- Study completion
- 11 May 2019 (actual)
- First posted
- 16 Aug 2017 (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 main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Other: Cardiac Rehabilitation ProgramParticipants randomized to this group will undergo cardiac rehabilitation program. |
| Control Group | Active comparator | Other: Conventional TherapyParticipants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with PAD post-revascularization (stent, angioplasty, or bypass).
- Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.
Key exclusion criteria (8 listed)
- Below or above the knee amputation.
- Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
- Unfavorable short term prognosis and limited life expectancy (<2 years)
- Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
- Prior history of having dropped out of CR without completing.
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 |
|---|---|---|
| Cardiac Rehabilitation ProgramProgram will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months. Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information. | Other | Cardiac Rehabilitation Group |
| Conventional TherapyParticipants will be asked to complete tests and questionnaires that would normally be done for their condition. | Other | Control Group |
Primary outcome
Change in 6 minute walk test
Time frame: Change from Baseline to Up to 6 Months
Results will be measured in meters.
6 secondary outcomes
Short Form Health Survey 36 (SF-36)
Time frame: Change from Baseline to Up to 6 Months
Short Form Health Survey 36 (SF-36)
Time frame: Change from Baseline to Week 18
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Time frame: Change from Baseline to Up to 6 Months
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Time frame: Change from Baseline to Week 18
Absolute Claudication Distance (ACD)
Time frame: Change from Baseline to Up to 6 Months
Functional Claudication Distance (FCD)
Time frame: Change from Baseline to Up to 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Peripheral Arterial Disease
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.
Kamal Gupta, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Program and Conventional Therapy in people with Peripheral Arterial Disease, run by University of Kansas Medical Center 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 2 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 6 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in 6 minute walk test (time frame: Change from Baseline to Up to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2019.