Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD)

NACompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

August 15, 2017

Study Completion Date

August 15, 2017

Conditions
Peripheral Arterial Disease
Interventions
BEHAVIORAL

Supervised Treadmill Exercise Therapy

Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.

OTHER

Health education sessions (Control)

Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.

DRUG

granulocyte macrophage colony stimulating factor (GM-CSF)

The dose of GM-CSF will be 250 ug/M\^2 subcutaneously three times weekly for two weeks.

Trial Locations (1)

60611

Northwestern University Feinberg School of Medicine, Chicago

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Northwestern University

OTHER

NCT01408901 - Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD) | Biotech Hunter | Biotech Hunter