Evaluating Two Exercise Training Programs to Reduce Leg Pain in People With Peripheral Arterial Disease (The EXERT Study)
EXERT
Exercise Training to Reduce Claudication: Arm Ergometry Versus Treadmill Walking
2 other identifiers
interventional
104
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2009
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedNovember 1, 2019
October 1, 2019
5.2 years
May 6, 2009
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximal walking distance
Measured at baseline and Weeks 6, 12, and 24
Pain-free walking distance
Measured at baseline and Weeks 6, 12, and 24
Secondary Outcomes (3)
Limb blood flow
Measured at baseline and Weeks 6, 12, and 24
Cardiovascular function
Measured at baseline and Weeks 6, 12, and 24
Quality of life
Measured at baseline and Weeks 6, 12, and 24
Study Arms (3)
Treadmill Exercise Training
EXPERIMENTALParticipants will take part in a 12-week supervised treadmill exercise training program.
Arm Ergometry Exercise Training
EXPERIMENTALParticipants will take part in a 12-week supervised aerobic arm ergometry exercise training program.
Usual Care Control Group
ACTIVE COMPARATORParticipants will receive usual care for PAD from their doctor.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diane J. Treat-Jacobson, PhD, RN
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
January 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
November 1, 2019
Record last verified: 2019-10