Peripheral Arterial DiseaseNCT02388685
Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
A study testing Exercise in people with Peripheral Arterial Disease, run by University of Virginia at 1 site in United States.
Trial summary
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 22 Nov 2023
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented ABI 0.5-0.9
- Ability to walk on treadmill
Who cannot join
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Critical limb ischemia
- Known or suspected peripheral neuropathy, heel cord contracture and foot deformity
- Other conditions that limit walking, e.g. lung disease or arthritis
- Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent (<2 months) myocardial infarction,
- BMI > 40,
- Known contraindication to MRI (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.)
- Allergy to lidocaine or xylocaine (local anesthetic)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).
Read the detailed description
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Exercise
- Keywords
- peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Home exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Home exercise | Experimental | Patients will undergo home exercise therapy under the supervision of the exercise laboratory Receives: Other: Exercise |
| No exercise | No intervention | Patients will continue with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise calf muscle perfusion
Arterial spin labeling MRI at peak exercise
Measured: Change from baseline at 12 weeks
Exercise calf muscle energetics
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise
Measured: Change from baseline at 12 weeks
Secondary outcomes (3)
Calf muscle capillary density
Biopsy sample of calf muscle for capillary density
Measured: Change from baseline at 12 weeks
Treadmill testing
Treadmill testing with peak VO2 measures
Measured: Change from baseline at 12 weeks
6-minute walk test
6-minute walk test
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2020
- Study completion22 Nov 2023
Why it stopped: Inadequate patient recruitment
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.
- More trials run by University of VirginiaThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kramer, University of Virginia
- Investigators
- Christopher M Kramer, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388685
- Sponsor's protocol ID
- IRB-HSR# 16084
- Status last verified
- Nov 2023
- First submitted
- 4 Mar 2015
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
- ClinicalTrials.gov ID
- NCT02388685
- Acronym / sponsor ID
- IRB-HSR# 16084
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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 goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).
Detailed description
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home exercise | Experimental | Other: ExercisePatients will undergo home exercise therapy under the supervision of the exercise laboratory |
| No exercise | No intervention | –Patients will continue with usual care |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented ABI 0.5-0.9
- Ability to walk on treadmill
Key exclusion criteria (8 listed)
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Critical limb ischemia
- Known or suspected peripheral neuropathy, heel cord contracture and foot deformity
- Other conditions that limit walking, e.g. lung disease or arthritis
- Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent (<2 months) myocardial infarction,
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 |
|---|---|---|
| ExerciseHome exercise therapy | Other | Home exercise |
Primary outcome
Exercise calf muscle perfusion
Time frame: Change from baseline at 12 weeks
Arterial spin labeling MRI at peak exercise
Exercise calf muscle energetics
Time frame: Change from baseline at 12 weeks
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise
3 secondary outcomes
Calf muscle capillary density
Time frame: Change from baseline at 12 weeks
Treadmill testing
Time frame: Change from baseline at 12 weeks
6-minute walk test
Time frame: Change from baseline at 12 weeks
Results and safety
The study was stopped early (reason given: Inadequate patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
Christopher M Kramer, MD principal investigator
University of Virginia Health System
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 in people with Peripheral Arterial Disease, run by University of Virginia 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: stopped early, as of the sponsor's last update on 30 Nov 2023. 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: Inadequate patient recruitment). 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?
Exercise calf muscle perfusion (time frame: Change from baseline at 12 weeks). The study lists 2 primary outcomes in all. 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 30 Nov 2023.