Prehabilitation for PAD Revascularization Patients

NCT02767895 | Terminated

• 1 other identifier: HUM00113096
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Increased Physical Activity Characteristics

  8 months

• Health-related Quality of Life

  8 months

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Prehabilitation 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.

Also known as: MSHOP - Michigan Surgical & Health Optimization Program

Prehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elizabeth Jackson, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: July 1, 2016
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)