Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)
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ClinicalTrials.gov Identifier: NCT02189018 |
Recruitment Status :
Enrolling by invitation
First Posted : July 14, 2014
Last Update Posted : July 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Arterial Occlusive Disease | Other: Active Exercise Other: Neuromuscular electrical stimulation Other: Weight loss and active exercise Other: Ad lib activity at home | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Activity To Improve Outcomes in Peripheral Arterial Disease |
Actual Study Start Date : | August 2014 |
Estimated Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Control
Ad lib activity at home
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Other: Ad lib activity at home
Ad lib activity at home |
Experimental: Active Exercise
Active exercise on treadmill
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Other: Active Exercise
Active exercise on a treadmill |
Experimental: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation
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Other: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation |
Experimental: Weight loss and active exercise
Weight loss plus active exercise on treadmill
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Other: Weight loss and active exercise
Weight loss and active exercise on a treadmill |
- Lower extremity perfusion [ Time Frame: 6 months ]Ankle brachial index and ultrasound quantification of muscle perfusion
- Functional capacity [ Time Frame: 6 months ]Treadmill exercise testing

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Ages Eligible for Study: | 21 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189018
United States, Maryland | |
Baltimore VAMC | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Brajesh K Lal, MD | Baltimore VAMC, University of Maryland School of Medicine |
Responsible Party: | Brajesh K Lal, Professor, Baltimore VA Medical Center |
ClinicalTrials.gov Identifier: | NCT02189018 |
Other Study ID Numbers: |
HP-00059151 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | July 8, 2020 |
Last Verified: | July 2020 |
Peripheral arterial disease Endovascular Exercise Perfusion Functional capacity |
Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Atherosclerosis |
Arteriosclerosis Vascular Diseases Cardiovascular Diseases |