Exercise Rehabilitation in Veterans With PAD

Status Completed

Clinical Trial Summary

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

Clinical Trial Description

Peripheral artery disease (PAD) and its associated declines in physical function impair quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health care costs. Revascularization addresses the anatomical pathology, but does not restore mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation to address lingering defects in skeletal muscle that limit function; however, the current standard of care after revascularization does not include rehabilitation. Exercise training and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle perfusion to improve outcomes in older Veterans with PAD after revascularization. The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for percutaneous revascularization. Participants will complete research testing consisting of: a) Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion. Participants will undergo screening prior to revascularization and will have baseline testing 2-3 weeks after revascularization. After post-revascularization testing, patients will be randomized to Exercise-only or NMES-only. After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02607046
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2015
Completion date	December 20, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK 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
Active, not recruiting	`NCT04677725` - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Recruiting	`NCT06047002` - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed	`NCT03185052` - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach	N/A
Recruiting	`NCT05992896` - A Study of Loco-Regional Liposomal Bupivacaine Injection	Phase 4
Completed	`NCT04635501` - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial	N/A
Recruiting	`NCT04584632` - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery	N/A
Withdrawn	`NCT03994185` - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease	N/A
Withdrawn	`NCT03538392` - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting	`NCT02915796` - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty	Phase 1
Active, not recruiting	`NCT02900924` - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed	`NCT02901847` - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.	N/A
Withdrawn	`NCT02126540` - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries	N/A
Not yet recruiting	`NCT02455726` - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease	N/A
Not yet recruiting	`NCT02387450` - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication	Phase 2/Phase 3
Completed	`NCT02022423` - Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease	N/A