Recruiting

Prehabilitation & Rehabilitation

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT06566976

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

VAPAHCS Rehabilitation Core Components

Study Details

Brief summary:

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

Conditions

Peripheral Arterial Disease

Study ID

NCT06566976

Start date

Mar 7, 2024

Status verified date

Aug, 2024

Completion date

Jul 25, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Medically unstable patients
  • Recent MI within 3 months
  • Malignancy
  • Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
  • Alcoholism or other recreational drug use

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Exercise Intervention

Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance.

VAPAHCS Rehabilitation Core Components

The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal.

Primary outcome measure

  • Time to claudication pain [ Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks ]

Central Contacts and Locations

Central contacts

Jonathan N Myers, PhD

650-493-5000drj993@aol.com

Charles G Gronau, DCEP

618-746-69565gronauc92@gmail.com

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Jonathan N Myers, PhD

650-493-5000drj993@aol.com

Charles G Gronau, DCEP

618-746-6956gronauc92@gmail.com

Principal Investigator:

Jonathan N Myers, PhD

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2024-08-22.