ACTION: Activity To Improve Outcomes in Peripheral Arterial Disease
Study Details
Study Description
Brief Summary
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs 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 is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.
We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Control Ad lib activity at home |
Other: Ad lib activity at home
Ad lib activity at home
|
Experimental: Active Exercise Active exercise on treadmill |
Other: Active Exercise
Active exercise on a treadmill
|
Experimental: Neuromuscular electrical stimulation Neuromuscular electrical stimulation |
Other: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation
|
Experimental: Weight loss and active exercise Weight loss plus active exercise on treadmill |
Other: Weight loss and active exercise
Weight loss and active exercise on a treadmill
|
Outcome Measures
Primary Outcome Measures
- Lower extremity perfusion [6 months]
Ankle brachial index and ultrasound quantification of muscle perfusion
Secondary Outcome Measures
- Functional capacity [6 months]
Treadmill exercise testing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 21-90 years
-
Ankle brachial index < 0.9
Exclusion Criteria:
-
Cancer under active treatment, except prostate, skin, and hematologic cancers
-
Planned for open lower extremity bypass surgery
-
Body mass index >45
-
Lower extremity gangrene
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Baltimore VAMC | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Baltimore VA Medical Center
Investigators
- Principal Investigator: Brajesh K Lal, MD, Baltimore VAMC, University of Maryland School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HP-00059151