Prehabilitation for PAD Revascularization Patients

A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization

Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.

Study Overview

• Status: Terminated
• Conditions: Peripheral Vascular Disease; Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Prehabilitation

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: Prehabilitation; 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.; Other Names: MSHOP - Michigan Surgical & Health Optimization Program
NO_INTERVENTION: Usual Care; Participants will follow the pre-operative instructions provided by their surgical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Study as Indicated by Number of Participants	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.	1 day
Acceptability of Study as Indicated by Percentage of Participation	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.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Physical Activity Characteristics	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.	8 months
Health-related Quality of Life	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.	8 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elizabeth Jackson, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): November 7, 2017
• Study Completion (ACTUAL): November 7, 2017

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HUM00113096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO