Peripheral Arterial DiseaseNCT02607046
Exercise Rehabilitation in Veterans With PAD
A study testing Exercise training and NMES in people with Peripheral Arterial Disease and Intermittent Claudication, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Exercise training and NMES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 20 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of peripheral arterial disease; or ankle-brachial index <0.9.
- Planned to undergo endovascular revascularization within 6 months.
Who cannot join
- Cancer under active treatment
- Planned for lower extremity bypass surgery
- Body mass index > 45 kg/m2
- Critical limb ischemia or lower extremity gangrene
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Post-revascularization Rehabilitation to Improve Function in Veterans With PAD
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.
Read the detailed description
Peripheral artery disease (PAD) and its associated declines in physical function impair quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health care costs. Revascularization addresses the anatomical pathology, but does not restore mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation to address lingering defects in skeletal muscle that limit function; however, the current standard of care after revascularization does not include rehabilitation. Exercise training and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle perfusion to improve outcomes in older Veterans with PAD after revascularization.
The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for percutaneous revascularization. Participants will complete research testing consisting of: a) Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion. Participants will undergo screening prior to revascularization and will have baseline testing 2-3 weeks after revascularization. After post-revascularization testing, patients will be randomized to Exercise-only or NMES-only. After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions.
- Being tested
- Exercise training, NMES
- Keywords
- rehabilitation, exercise training
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
The exercise program includes supervised and home-based walking and strength exercise.
NMESOther
This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise Training Receives: Other: Exercise training |
| NMES | Experimental | Neuromuscular Electrical Stimulation Receives: Other: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Physical Performance Test
Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)
Measured: 3 months
Six-minute Walk Distance
Test of ambulatory capacity
Measured: 3 months
Secondary outcomes (1)
Muscle Perfusion Measured by Ultrasound Scan
Calf Muscle Perfusion assessed as digital video intensity from recorded ultrasound scans. Units are scale data with a minimum = 0 and no predetermined maximum. Higher score = more perfusion.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 Dec 2019
- Study completion20 Dec 2023
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 (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven J. Prior, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607046
- Sponsor's protocol ID
- F1927-P
- Other IDs
- I21RX001927
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2015
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kundi R, Prior SJ, Addison O, Lu M, Ryan AS, Lal BK. Contrast-Enhanced Ultrasound Reveals Exercise-Induced Perfusion Deficits in Claudicants. J Vasc Endovasc Surg. 2017;2(1):9. doi: 10.21767/2573-4482.100041. Epub 2017 Mar 6.
PubMed 28691118Addison O, Prior SJ, Kundi R, Serra MC, Katzel LI, Gardner AW, Ryan AS. Sarcopenia in Peripheral Arterial Disease: Prevalence and Effect on Functional Status. Arch Phys Med Rehabil. 2018 Apr;99(4):623-628. doi: 10.1016/j.apmr.2017.10.017. Epub 2017 Nov 11.
PubMed 29138051Addison O, Kundi R, Ryan AS, Goldberg AP, Patel R, Lal BK, Prior SJ. Clinical relevance of the modified physical performance test versus the short physical performance battery for detecting mobility impairments in older men with peripheral arterial disease. Disabil Rehabil. 2018 Dec;40(25):3081-3085. doi: 10.1080/09638288.2017.1367966. Epub 2017 Aug 23.
PubMed 28835180Prior SJ, Chrencik MT, Christensen E, Kundi R, Ryan AS, Addison O, Lal BK. An exercise stress test for contrast-enhanced duplex ultrasound assessment of lower limb muscle perfusion in patients with peripheral arterial disease. J Vasc Surg. 2024 Feb;79(2):397-404. doi: 10.1016/j.jvs.2023.10.005. Epub 2023 Oct 14.
PubMed 37844848
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-revascularization Rehabilitation to Improve Function in Veterans With PAD
- ClinicalTrials.gov ID
- NCT02607046
- Acronym / sponsor ID
- F1927-P
- Keywords
- rehabilitation, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.
Detailed description
Peripheral artery disease (PAD) and its associated declines in physical function impair quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health care costs. Revascularization addresses the anatomical pathology, but does not restore mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation to address lingering defects in skeletal muscle that limit function; however, the current standard of care after revascularization does not include rehabilitation. Exercise training and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle perfusion to improve outcomes in older Veterans with PAD after revascularization.
The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for percutaneous revascularization. Participants will complete research testing consisting of: a) Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion. Participants will undergo screening prior to revascularization and will have baseline testing 2-3 weeks after revascularization. After post-revascularization testing, patients will be randomized to Exercise-only or NMES-only. After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise trainingExercise Training |
| NMES | Experimental | Other: NMESNeuromuscular Electrical Stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of peripheral arterial disease; or ankle-brachial index <0.9.
- Planned to undergo endovascular revascularization within 6 months.
Key exclusion criteria (4 listed)
- Cancer under active treatment
- Planned for lower extremity bypass surgery
- Body mass index > 45 kg/m2
- Critical limb ischemia or lower extremity gangrene
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 |
|---|---|---|
| Exercise trainingThe exercise program includes supervised and home-based walking and strength exercise. | Other | Exercise |
| NMESThis intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs. | Other | NMES |
Primary outcome
Modified Physical Performance Test
Time frame: 3 months
Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)
Six-minute Walk Distance
Time frame: 3 months
Test of ambulatory capacity
1 secondary outcome
Muscle Perfusion Measured by Ultrasound Scan
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28691118Kundi R, Prior SJ, Addison O, Lu M, Ryan AS, Lal BK. Contrast-Enhanced Ultrasound Reveals Exercise-Induced Perfusion Deficits in Claudicants. J Vasc Endovasc Surg. 2017;2(1):9. doi: 10.21767/2573-4482.100041. Epub 2017 Mar 6.
- Results publication: PubMed 29138051Addison O, Prior SJ, Kundi R, Serra MC, Katzel LI, Gardner AW, Ryan AS. Sarcopenia in Peripheral Arterial Disease: Prevalence and Effect on Functional Status. Arch Phys Med Rehabil. 2018 Apr;99(4):623-628. doi: 10.1016/j.apmr.2017.10.017. Epub 2017 Nov 11.
- Results publication: PubMed 28835180Addison O, Kundi R, Ryan AS, Goldberg AP, Patel R, Lal BK, Prior SJ. Clinical relevance of the modified physical performance test versus the short physical performance battery for detecting mobility impairments in older men with peripheral arterial disease. Disabil Rehabil. 2018 Dec;40(25):3081-3085. doi: 10.1080/09638288.2017.1367966. Epub 2017 Aug 23.
- Results publication: PubMed 37844848Prior SJ, Chrencik MT, Christensen E, Kundi R, Ryan AS, Addison O, Lal BK. An exercise stress test for contrast-enhanced duplex ultrasound assessment of lower limb muscle perfusion in patients with peripheral arterial disease. J Vasc Surg. 2024 Feb;79(2):397-404. doi: 10.1016/j.jvs.2023.10.005. Epub 2023 Oct 14.
- Individual participant dataSharing planned: No
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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.
Steven J. Prior, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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 training and NMES in people with Peripheral Arterial Disease and Intermittent Claudication, 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 2 inclusion and 4 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 Jan 2024. 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 15 Feb 2021). 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?
Modified Physical Performance Test (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT02607046, which also lists 4 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 18 Jan 2024.