Exercise before and after artery stenting for peripheral arterial disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease (narrowed leg arteries) who have leg pain when walking and are scheduled for a stent. It tests exercise before and/or after the stent.

Age

18 Years and older

Sex

Men and women. Women must be postmenopausal and not able to have children.

Disease stage

Peripheral artery disease with leg pain while walking. A stent for PAD must be scheduled.

Main reasons for not taking part

• Medically unstable health
• Heart attack (MI) within the last 3 months
• Cancer (malignancy)
• Uncontrolled diabetes (HBA1C ≥8 mmol/l)
• Alcoholism or recreational drug use

The registry criteria, word for word

What the trial wants to find out

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

The 3 groups in the trial

• PrehabilitationTreatment being tested

  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.

  Treatment: Exercise Intervention and VAPAHCS Rehabilitation Core Components

• RehabilitationExisting treatment, for comparison

  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.

  Treatment: Exercise Intervention and VAPAHCS Rehabilitation Core Components

• Prehabiliation and RehabilitationTreatment being tested

  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.

  Treatment: Exercise Intervention and VAPAHCS Rehabilitation Core Components