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Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189018
Recruitment Status : Enrolling by invitation
First Posted : July 14, 2014
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Brajesh K Lal, Baltimore VA Medical Center

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Lower extremity perfusion [ Time Frame: 6 months ]
Ankle brachial index and ultrasound quantification of muscle perfusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Functional capacity [ Time Frame: 6 months ]
Treadmill exercise testing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activity To Improve Outcomes in Peripheral Arterial Disease
Official Title  ICMJE Activity To Improve Outcomes in Peripheral Arterial Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Occlusive Disease
Intervention  ICMJE
  • Other: Active Exercise
    Active exercise on a treadmill
  • Other: Neuromuscular electrical stimulation
    Neuromuscular electrical stimulation
  • Other: Weight loss and active exercise
    Weight loss and active exercise on a treadmill
  • Other: Ad lib activity at home
    Ad lib activity at home
Study Arms  ICMJE
  • Active Comparator: Control
    Ad lib activity at home
    Intervention: Other: Ad lib activity at home
  • Experimental: Active Exercise
    Active exercise on treadmill
    Intervention: Other: Active Exercise
  • Experimental: Neuromuscular electrical stimulation
    Neuromuscular electrical stimulation
    Intervention: Other: Neuromuscular electrical stimulation
  • Experimental: Weight loss and active exercise
    Weight loss plus active exercise on treadmill
    Intervention: Other: Weight loss and active exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189018
Other Study ID Numbers  ICMJE HP-00059151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brajesh K Lal, Baltimore VA Medical Center
Study Sponsor  ICMJE Baltimore VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brajesh K Lal, MD Baltimore VAMC, University of Maryland School of Medicine
PRS Account Baltimore VA Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP