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Community-based Exercise Following Revascularization for PAD

ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity of Minnesota

About this trial

The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb

Patients with focal and/or diffuse peripheral artery disease

Bilateral Revascularization patients will also be included

Ability to participate in an exercise program

Disqualifiers

Lower extremity amputation(s) which interfere(s) with walking on the treadmill

Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities

PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis).

Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • CB-SET

    Behavioral

    Community-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed

  • Revascularization

    Procedure/Surgery

    Endovascular revascularization is a primary treatment option for patients with PAD

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CB-SET TreatmentExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Peak Walking Time (PWT)

Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise. PWT (reported in minutes) will be recorded as the maximal time a participant can walk on the treadmill before having to stop due to severe claudication (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).

Time frame
Baseline, 12 weeks

Secondary outcomes

1

Change in Claudication Onset Time (COT)

Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise. COT (reported in minutes) will be obtained with the patient pointing to the pain scale at the initial presentation of leg pain (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).

Time frame
Baseline, 12 weeks
2

Change in VO2max

VO2 max is the maximum rate of oxygen consumption measured during incremental exercise. Participants will perform graded exercise tests conducted on a treadmill while oxygen consumption is measured and recorded. Maximum rate of oxygen consumption during exercise will be reported in mL/kg\*min-1.

Time frame
Baseline, 12 weeks
3

Total Volume of Exercise

Patients will be monitored with a piezoelectric accelerometer over the duration of the 12 total weeks to determine total volume of activity. The average minutes of activity per day will be reported.

Time frame
12 weeks
4

Adherence to Exercise

Participants will be given a StepWatch accelerometer. Exercise compliance will be calculated for PAD participants as the total number of completed sessions divided by 36 (3 sessions/week for 12 weeks).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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