Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I21RX001927 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Exercise Training |
|
| NMES | Experimental | Neuromuscular Electrical Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | The exercise program includes supervised and home-based walking and strength exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Physical Performance Test | Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome) | 3 months |
| Six-minute Walk Distance | Test of ambulatory capacity | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven J. Prior, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28691118 | Result | 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. | |
| 29138051 | Result | Addison 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
56 participants enrolled; only 35 participants completed baseline testing and were randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Exercise Training Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise. |
| FG001 | NMES | Neuromuscular Electrical Stimulation NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Exercise Training Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise. |
| BG001 | NMES | Neuromuscular Electrical Stimulation NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Physical Performance Test | Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome) | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Exercise Training Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Non-systematic Assessment | Exertional chest pain. Brief hospitalization; no intervention required |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Prior | Department of Veterans Affairs | 410-605-7000 | 54129 | steven.prior@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2019 | Dec 21, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NMES | Other | This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs. |
|
| 28835180 | Result | Addison 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. |
| 37844848 | Result | Prior 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Modified Physical Performance Test | Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome) | Mean | Standard Deviation | scores on a scale |
|
| Six-minute Walk Distance | Test of Ambulatory Capacity | Mean | Standard Deviation | feet |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Six-minute Walk Distance | Test of ambulatory capacity | Posted | Mean | Standard Deviation | feet | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 4 |
| 22 |
| EG001 | NMES | Neuromuscular Electrical Stimulation NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs. | 0 | 13 | 0 | 13 | 1 | 13 |
|
| Elevated Blood Glucose | Endocrine disorders | Non-systematic Assessment |
|
| Cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Toe injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Toe wound unrelated to study |
|
| Hypotension | Vascular disorders | Non-systematic Assessment | Single bout of hypotension |
|
Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |