Peripheral Artery Disease Clinical Trials

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Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or Female adult diagnosed with peripheral artery disease (PAD)

• Experiencing leg pain while walking

• Scheduled to have a stent for PAD

• Able to perform exercise safely

• Postmenopausal and not of child bearing capacity

Locations
United States
California
VA Palo Alto Health Care System
RECRUITING
Palo Alto
Contact Information
Primary
Jonathan N Myers, PhD
drj993@aol.com
650-493-5000
Backup
Charles G Gronau, DCEP
gronauc92@gmail.com
618-746-69565
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2027-07-25
Participants
Target number of participants: 300
Treatments
Experimental: Prehabilitation
Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed.
Active_comparator: Rehabilitation
Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD.
Experimental: Prehabiliation and Rehabilitation
Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions.
Sponsors
Leads: Palo Alto Veterans Institute for Research
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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