Back to resultsPrehabilitation for PAD Revascularization Patients
Primary Purpose
Peripheral Vascular Disease, Peripheral Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation
Usual Care
Arm Description
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
Participants will follow the pre-operative instructions provided by their surgical team.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767895
Brief Title
Prehabilitation for PAD Revascularization Patients
Official Title
A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with enrollment and change in available study resources
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease, Peripheral Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will follow the pre-operative instructions provided by their surgical team.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Other Intervention Name(s)
MSHOP - Michigan Surgical & Health Optimization Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Study as Indicated by Number of Participants
Description
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.
Time Frame
1 day
Title
Acceptability of Study as Indicated by Percentage of Participation
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Increased Physical Activity Characteristics
Description
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.
Time Frame
8 months
Title
Health-related Quality of Life
Description
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.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Jackson, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation for PAD Revascularization Patients
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