Prehabilitation for PAD Revascularization Patients

NCT ID: NCT02767895

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-11-07

Brief Summary

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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

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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.

Conditions

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Peripheral Vascular Disease Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

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.

Usual Care

Participants will follow the pre-operative instructions provided by their surgical team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MSHOP - Michigan Surgical & Health Optimization Program

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth A. Jackson

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Jackson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00113096

Identifier Type: -

Identifier Source: org_study_id

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