Evaluating Two Exercise Training Programs to Reduce Leg Pain in People With Peripheral Arterial Disease (The EXERT Study)
Condition: Intermittent Claudication; Peripheral Vascular Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Intermittent Claudication
Study type: Interventional
Phase: Phase 3

Summary: 
      Peripheral arterial disease (PAD) is a disorder that affects more than 8 million people in
      the United States. As a result of decreased blood flow to the legs, people with PAD may
      experience leg pain and difficulty with walking. This study will examine the effectiveness of
      two exercise programs-a treadmill walking program and an aerobic arm exercise program-at
      increasing walking distance and decreasing leg pain in people with PAD.
    

Detailed description: 
      PAD is a condition that occurs when atherosclerotic plaque builds up in the peripheral
      arteries and restricts blood flow. People with PAD often experience reduced blood flow to the
      legs, which may cause painful leg cramping while walking, known as intermittent claudication.
      Claudication affects over 4 million people in the United States, and many people with this
      condition can walk only ½ to 2 blocks before leg pain begins to occur. Regular treadmill
      walking has been shown to be effective at increasing walking distance and reducing
      claudication in people with PAD. However, walking on a treadmill may prove difficult for some
      people with PAD and usually causes increased leg pain, both of which may reduce exercise
      frequency. Aerobic arm exercises do not cause leg pain and may be an effective way for people
      with PAD to improve overall cardiovascular fitness and increase the amount of exercise they
      do. The purpose of this study is to compare the effectiveness of a treadmill exercise program
      and an aerobic arm exercise program at reducing symptoms of claudication and improving
      walking ability in people with PAD.

      This study will enroll people with PAD and claudication. At a baseline study visit,
      participants will complete a treadmill walking test; a blood collection; and questionnaires
      to assess walking status, daily activity levels, quality of life, and mood. One week after
      the baseline visit, participants will attend a study visit for an assessment of forearm and
      leg muscle blood flow and a hand-bike test that will measure upper body strength using an arm
      cycle ergometer. The ergometer is a device with bicycle pedals that people move using their
      arms. Participants will then be randomly assigned to either a treadmill exercise training
      program, an arm ergometry exercise program, or a control group.

      Participants in the treadmill exercise training program will attend a supervised program at
      one of four study sites and exercise on a treadmill for 1 hour three times a week for 12
      weeks. Participants in the arm ergometry exercise program will attend a supervised program at
      one of four study sites and exercise using an arm cycle ergometer (hand-bike) for 1 hour
      three times a week for 12 weeks. Participants in both groups will also receive written
      instructions about exercising on their own. Participants in the control group will continue
      to receive usual care from their regular doctor for the treatment of PAD and will be provided
      with written exercise instructions. Once a week for 12 weeks, participants in the control
      group will attend study visits to discuss any health problems.

      All participants will be asked to monitor their daily exercise for 3 separate weeks during
      the 12-week period by wearing an accelerometer, which will measure and record physical
      activity. They will also record their exercise habits in a written diary. All participants
      will attend study visits on 2 separate days at Weeks 6 and 12 for repeat baseline testing.

      From Weeks 12 to 24, all participants will be encouraged to continue to exercise on their own
      at least three times a week for 30 minutes. Every 4 weeks, study researchers will call
      participants to offer encouragement and answer questions. At Week 23, participants will again
      wear an accelerometer and keep an exercise diary for 1 week. All participants will attend a
      final study visit at Week 24 for repeat baseline testing.
    

Intervention name(s): Treadmill Exercise Training; Arm Ergometry Exercise Training; Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 60-minute sessions of supervised treadmill exercise training three times a week for 12 weeks; 60-minute sessions of supervised aerobic arm exercise training using an arm ergometer three times a week for 12 weeks; Usual care for PAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Claudication; Peripheral Arterial Disease; Exercise Rehabilitation; Cardiovascular Function