Exercise Rehabilitation in Veterans With PAD
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - 80 |
| Updated: | 1/20/2019 |
| Start Date: | October 1, 2015 |
| End Date: | December 31, 2020 |
| Contact: | Eric Christensen, MS |
| Email: | echristensen@medicine.umaryland.edu |
| Phone: | (410) 605-7000 |
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
and neuromuscular stimulation on leg blood flow, physical function, quality of life and
general health.
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
and 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. Together, these two therapies may work in a complementary manner 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; b) Treadmill tests to assess ambulatory capacity,
and calf muscle perfusion; and c) A gastrocnemius needle biopsy to measure capillary density
and angiogenic growth factor expression. Participants will undergo baseline testing prior to
revascularization and will repeat research testing 2-3 weeks after revascularization to
determine the effect of only revascularization on functional outcomes. After
post-revascularization testing, 52 patients will be randomized to one of four groups
(Exercise-only, NMES-only, Exercise+NMES, or Standard Care; n=13/group). After completion of
the 3-month intervention, participants will repeat all tests to determine the effects of the
interventions compared to standard care.
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. Together, these two therapies may work in a complementary manner 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; b) Treadmill tests to assess ambulatory capacity,
and calf muscle perfusion; and c) A gastrocnemius needle biopsy to measure capillary density
and angiogenic growth factor expression. Participants will undergo baseline testing prior to
revascularization and will repeat research testing 2-3 weeks after revascularization to
determine the effect of only revascularization on functional outcomes. After
post-revascularization testing, 52 patients will be randomized to one of four groups
(Exercise-only, NMES-only, Exercise+NMES, or Standard Care; n=13/group). After completion of
the 3-month intervention, participants will repeat all tests to determine the effects of the
interventions compared to standard care.
Inclusion Criteria:
- Diagnosis of peripheral arterial disease; or ankle-brachial index <0.9.
- Planned to undergo endovascular revascularization within 6 months.
Exclusion Criteria:
- Cancer under active treatment
- Planned for lower extremity bypass surgery
- Body mass index > 45 kg/m2
- Critical limb ischemia or lower extremity gangrene
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Steven J. Prior, PhD
Phone: 410-605-7000
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