Patient Centered Home Exercise Program for Peripheral Artery Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease. In 200 patients with peripheral artery disease (PAD), the investigators are conducting a randomized controlled trial to determine whether a patient-centered home-based exercise program improves walking ability, physical activity, mobility, pain, and social functioning, compared to a usual care group.

Clinical Trial Description

Lower extremity peripheral artery disease (PAD) is a common and chronic condition that affects 8 million people in the United States. PAD patients have difficulty walking because cholesterol blockages in their leg arteries prevent adequate oxygen supply to leg muscles during that activity. PAD patients reduce their physical activity levels and slow their walking speed to avoid leg pain.

Few therapies are available to help PAD patients improve their walking limitations. Treadmill exercise programs that require three or more supervised exercise sessions per week at an exercise facility can help PAD patients walk with less pain. However, most people with PAD do not participate in supervised exercise programs because they are not paid for by medical insurance and the requirements are burdensome for the patients.

The investigators have engaged PAD patients and relevant stakeholders to develop a home-based exercise intervention that is tailored to the needs of the patients. Our home-based exercise intervention includes a Fitbit activity monitor and a coach who will telephone PAD participants at regularly scheduled intervals. PAD patients will use the Fitbit to help them monitor their exercise behavior. The coach will use well-established behavioral methods during the scheduled telephone calls to help PAD patients adhere to regular walking exercise.

The investigators will conduct a randomized controlled trial of 200 patients with PAD to determine whether our home-based walking exercise program significantly improves walking performance and other patient-centered outcomes at the nine-month follow-up, compared to usual care.

PAD patients selected the trial's outcome measures as those that best represent PAD patients' physical limitations. All outcomes are well-validated and accepted outcome measures. The primary outcome measure is the six-minute walk test, an objective measure of walking endurance. Secondary outcomes consist of the Walking Impairment Questionnaire and the PROMIS questionnaires that assess patient-perceived walking ability, mobility, pain, and social functioning.

If our home-based exercise intervention is successful, the intervention will have a substantial impact on the large and growing number of people disabled by PAD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02462824
Study type	Interventional
Source	Northwestern University
Contact
Status	Completed
Phase	N/A
Start date	April 2015
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05712395` - The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease	N/A
Active, not recruiting	`NCT04534257` - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Completed	`NCT02554266` - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed	`NCT03921905` - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting	`NCT06369350` - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion	Early Phase 1
Recruiting	`NCT04545268` - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance	N/A
Recruiting	`NCT02389023` - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery	N/A
Completed	`NCT02522884` - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries	N/A
Completed	`NCT02539940` - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed	`NCT02563535` - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia	Phase 4
Completed	`NCT02542267` - In-Stent Restenosis Post-Approval Study	N/A
Completed	`NCT02145065` - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)	N/A
Completed	`NCT02262949` - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System	N/A
Completed	`NCT02228564` - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease	N/A
Completed	`NCT01743872` - Optical Imaging Measurement of Intravascular Solution Efficacy Trial	N/A
Recruiting	`NCT01424020` - Walking Estimated Limitation Calculated by History - Study 2	Phase 4
Active, not recruiting	`NCT01597453` - NOR-SYS: The Norwegian Stroke in the Young Study	N/A