ACTION: Activity To Improve Outcomes in Peripheral Arterial Disease

• Sponsor: Baltimore VA Medical Center (U.S. Fed)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02189018
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 0.7

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
Peripheral Arterial Occlusive Disease	Other: Active Exercise; Other: Neuromuscular electrical stimulation; Other: Weight loss and active exercise; Other: Ad lib activity at home	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

• Study Type: Interventional
• Anticipated 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: Aug 1, 2014
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

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

1. Lower extremity perfusion [6 months]

   Ankle brachial index and ultrasound quantification of muscle perfusion

Secondary Outcome Measures

1. Functional capacity [6 months]

   Treadmill exercise testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• 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

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.

• Responsible Party: Brajesh K Lal, Professor, Baltimore VA Medical Center
• ClinicalTrials.gov Identifier: NCT02189018
• Other Study ID Numbers: HP-00059151
• First Posted: Jul 14, 2014
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Brajesh K Lal, Professor, Baltimore VA Medical Center: Peripheral arterial disease; Endovascular; Exercise; Perfusion; Functional capacity
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Study Results

No Results Posted as of Mar 2, 2022