Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Exercise
Neuromuscular electrical stimulation
Weight loss and active exercise
Ad lib activity at home
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity
Eligibility 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
Sites / Locations
- Baltimore VAMC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Control
Active Exercise
Neuromuscular electrical stimulation
Weight loss and active exercise
Arm Description
Ad lib activity at home
Active exercise on treadmill
Neuromuscular electrical stimulation
Weight loss plus active exercise on treadmill
Outcomes
Primary Outcome Measures
Lower extremity perfusion
Ankle brachial index and ultrasound quantification of muscle perfusion
Secondary Outcome Measures
Functional capacity
Treadmill exercise testing
Full Information
NCT ID
NCT02189018
First Posted
July 10, 2014
Last Updated
July 26, 2023
Sponsor
Baltimore VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02189018
Brief Title
Activity To Improve Outcomes in Peripheral Arterial Disease
Acronym
ACTION
Official Title
Activity To Improve Outcomes in Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
Keywords
Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Ad lib activity at home
Arm Title
Active Exercise
Arm Type
Experimental
Arm Description
Active exercise on treadmill
Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation
Arm Title
Weight loss and active exercise
Arm Type
Experimental
Arm Description
Weight loss plus active exercise on treadmill
Intervention Type
Other
Intervention Name(s)
Active Exercise
Intervention Description
Active exercise on a treadmill
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Neuromuscular electrical stimulation
Intervention Type
Other
Intervention Name(s)
Weight loss and active exercise
Intervention Description
Weight loss and active exercise on a treadmill
Intervention Type
Other
Intervention Name(s)
Ad lib activity at home
Intervention Description
Ad lib activity at home
Primary Outcome Measure Information:
Title
Lower extremity perfusion
Description
Ankle brachial index and ultrasound quantification of muscle perfusion
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional capacity
Description
Treadmill exercise testing
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brajesh K Lal, MD
Organizational Affiliation
Baltimore VAMC, University of Maryland School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VAMC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Activity To Improve Outcomes in Peripheral Arterial Disease
We'll reach out to this number within 24 hrs