← Back to Search

Behavioural Intervention

Exercise Therapy for PAD (PREPARE-IT Trial)

N/A

Recruiting

Research Sponsored by Palo Alto Veterans Institute for Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Scheduled to have a stent for PAD

Must not have

Recent MI within 3 months

History of malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 14 weeks, 22 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if exercise therapy before and after surgery can help patients getting stents for peripheral artery disease."

Who is the study for?

This trial is for patients with Peripheral Arterial Disease (PAD) who are scheduled to undergo artery stenting. Specific eligibility criteria details are not provided, so it's important to contact the study team for more information.

What is being tested?

The trial examines whether exercise before and after surgery (prehabilitation and rehabilitation) can improve outcomes in PAD patients receiving artery stents. It involves an Exercise Intervention alongside VAPAHCS Rehabilitation Core Components.

What are the potential side effects?

While specific side effects are not listed, exercise interventions may include muscle soreness, fatigue, or exacerbation of existing PAD symptoms. Always consult with healthcare providers regarding potential risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with peripheral artery disease.

Select...

I am scheduled to receive a stent for peripheral artery disease.

Select...

I am postmenopausal and cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a heart attack in the last 3 months.

Select...

I have had cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 14 weeks, 22 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 14 weeks, 22 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 14 weeks, 22 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to claudication pain

Secondary study objectives

6-minute walk test (6MWT)

ALK Phosphatase

ALT/GPT

+27 more

Other study objectives

Ankle-brachial index (ABI)

Endothelial function

Exercise Benefits and Barriers Scale (EBBS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PrehabilitationExperimental Treatment2 Interventions

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.

Group II: Prehabiliation and RehabilitationExperimental Treatment2 Interventions

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.

Group III: RehabilitationActive Control2 Interventions

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.

0 / 5Eligibility criteria met