Peripheral Artery Disease, Peripheral Vascular Disease
Conditions
Brief summary
Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.
Detailed description
Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a prehabilitation program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.
Interventions
BEHAVIORALPrehabilitation
Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented lower extremity PAD * Ability to walk at least 1 block * Sedentary * Medical clearance from the surgical team * Competent to provide consent
Exclusion criteria
* Life expectancy \< 6 months * Co-morbidities which limit walking to a severe degree * Signs of critical limb ischemia * Recent or current enrollment in a formal exercise program * Recent cardiovascular events including stroke, TIA, severe valve disease, etc. * Current substance abuse * Psychiatric disorder which limits ability to participate in study procedures * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Study as Indicated by Percentage of Participation | 8 months | The willingness of patients to enroll and complete the basic study procedures. Acceptability will be defined as low drop out-rates (\<15%), completion of quality of life surveys, and \>85% usage of the pedometers. |
| Feasibility of Study as Indicated by Number of Participants | 1 day | The feasibility of the study will be assessed by analyzing the recruitment of subjects to the study and the compliance of recruited subjects to the protocol. Feasibility will be defined as able to screening, approaching, and enrolling 25 eligible patients to the pilot study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increased Physical Activity Characteristics | 8 months | Increased physical activity characteristics will be assessed through the Godin Leisure Time and International Physical Activity Questionnaire, and questionnaires on barriers to and self-efficacy of exercise. |
| Health-related Quality of Life | 8 months | Health-related quality of life and physical activity characteristics will be measured during the pre, peri, and post-operative period. This will be done through PROMIS surveys, which assess physical function, fatigue, depression, anxiety, and ability to participate in and satisfaction with social roles/activities. |
Countries
United States
Outcome results
None listed