Peripheral Arterial Disease
Conditions
Keywords
revascularization, blocked arteries, leg arteries, leg pain
Brief summary
The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.
Interventions
Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months. Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.
OTHERConventional Therapy
Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with PAD post-revascularization (stent, angioplasty, or bypass). * Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.
Exclusion criteria
* Below or above the knee amputation. * Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC). * Unfavorable short term prognosis and limited life expectancy (\<2 years) * Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned). * Prior history of having dropped out of CR without completing. * Unwilling to consent for all aspects of CR or study participation. * Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility). * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk test | Change from Baseline to Up to 6 Months | Results will be measured in meters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Health Survey 36 (SF-36) | Change from Baseline to Up to 6 Months | Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability. |
| Vascular Quality of Life Questionnaire-6 (VascuQol6) | Change from Baseline to Up to 6 Months | The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status. |
| Absolute Claudication Distance (ACD) | Change from Baseline to Up to 6 Months | ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters |
| Functional Claudication Distance (FCD) | Change from Baseline to Up to 6 Months | FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters. |
Countries
United States
Outcome results
None listed