Prehabilitation for PAD Revascularization Patients

Peripheral Artery Disease Clinical Trial

Official title:

A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02767895
• Other study ID #: HUM00113096
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: November 7, 2017

Study information

• Verified date: September 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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