Activity To Improve Outcomes in Peripheral Arterial Disease

Peripheral Arterial Occlusive Disease Clinical Trial

— ACTION  

Official title:

Activity To Improve Outcomes in Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189018
• Other study ID #: HP-00059151
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 4, 2023

Study information

• Verified date: July 2023
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 4, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Active Exercise
Active exercise on a treadmill
• Neuromuscular electrical stimulation
Neuromuscular electrical stimulation
• Weight loss and active exercise
Weight loss and active exercise on a treadmill
• Ad lib activity at home
Ad lib activity at home

Locations

Country	Name	City	State
United States	Baltimore VAMC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Baltimore VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity perfusion	Ankle brachial index and ultrasound quantification of muscle perfusion	6 months
Secondary	Functional capacity	Treadmill exercise testing	6 months