NCT03251391 - Cardiac Rehabilitation Program in Peripheral Arterial Disease | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

22

Conditions

Peripheral Arterial Disease

Interventions

Cardiac Rehabilitation ProgramOTHER

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.

Conventional TherapyOTHER

Participants will be asked to complete tests and questionnaires that would normally be done for their condition.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Change in 6 minute walk test

Results will be measured in meters.

Time frame: Change from Baseline to Up to 6 Months

Secondary Outcomes

Short Form Health Survey 36 (SF-36)

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.

Time frame: Change from Baseline to Up to 6 Months

Short Form Health Survey 36 (SF-36)

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.

Time frame: Change from Baseline to Week 18

Vascular Quality of Life Questionnaire-6 (VascuQol6)

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.

Time frame: Change from Baseline to Up to 6 Months

Vascular Quality of Life Questionnaire-6 (VascuQol6)

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.