Evaluating Two Exercise Training Programs to Reduce Leg Pain in People With Peripheral Arterial Disease (The EXERT Study)

Intermittent Claudication Clinical Trial

— EXERT  

Official title:

Exercise Training to Reduce Claudication: Arm Ergometry Versus Treadmill Walking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895635
• Other study ID #: 0803M28683
• Secondary ID: R01HL090854-01A1
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: April 2014

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Has lifestyle-limiting claudication

• Able to walk on a treadmill at 2 mph

• Able to perform arm ergometry exercise

• Able to complete a 12-week exercise program

Exclusion Criteria:

• Physical activities are limited for reasons other than claudication

• Uncontrolled high blood pressure

• Uncontrolled diabetes

• Unstable coronary heart disease

• Ischemic rest pain or tissue loss

• Recent (in the 3 months before study entry) coronary or peripheral revascularization

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Behavioral:
• Treadmill Exercise Training
60-minute sessions of supervised treadmill exercise training three times a week for 12 weeks
• Arm Ergometry Exercise Training
60-minute sessions of supervised aerobic arm exercise training using an arm ergometer three times a week for 12 weeks
• Usual Care
Usual care for PAD

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal walking distance		Measured at baseline and Weeks 6, 12, and 24
Primary	Pain-free walking distance		Measured at baseline and Weeks 6, 12, and 24
Secondary	Limb blood flow		Measured at baseline and Weeks 6, 12, and 24
Secondary	Cardiovascular function		Measured at baseline and Weeks 6, 12, and 24
Secondary	Quality of life		Measured at baseline and Weeks 6, 12, and 24