Prehabilitation for PAD Revascularization Patients

Not Applicable

Terminated

• Conditions: Peripheral Artery Disease; Peripheral Vascular Disease
• Interventions: Behavioral: Prehabilitation

• Registration Number: NCT02767895
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-10
• Study Start: 2016-07-01
• Primary Completion: 2017-11-07
• Study Completion: 2017-11-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Documented lower extremity PAD
• Ability to walk at least 1 block
• Sedentary
• Medical clearance from the surgical team
• Competent to provide consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	Participants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States