Prehabilitation and Rehabilitation in PAD
ConditionPeripheral Arterial Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPalo Alto Veterans Institute for Research
About this trial
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Medically unstable patients
Recent MI within 3 months
Malignancy
Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Intervention
Other interventionAerobic 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
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: PrehabilitationExperimental treatment 2 interventions
Group B: RehabilitationActive comparator 2 interventions
Group C: Prehabiliation and RehabilitationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Time to claudication pain
Time to initial onset of claudication pain with exercise treadmill test.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeksSecondary outcomes
1
Peak VO2
Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeks2
6-minute walk test (6MWT)
Total distance (meters) of walk in 6 minutes.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeks3
Walking Impairment Questionnaire (WIQ)
Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeks4
Peripheral Artery Questionnaire (PAQ)
20-item questionnaire developed and validated specifically for PAD and is designed to quantify patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeksOther outcomes
1
Endothelial function
The Endo Pat 2000 system will be used to perform this procedure. Both forearms will be occluded with a standard blood pressure cuff for 5 minutes.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeks2
Ankle-brachial index (ABI)
Using a standard brachial artery cuff method with a Doppler ultrasound probe at the posterior tibial artery to determine ABI.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeks3
Exercise Benefits and Barriers Scale (EBBS)
Perceived barriers and benefits to physical activity will be assessed using two methods: a semi-structured interview and administration of the Exercise Benefits and Barriers Scale (EBBS), to obtain both open-ended qualitative and quantitative data on these constructs. The EBBS may be used in its entirety or as two seperate scales. As a whole, scoring for EBBS ranges from 43 to 172 with a higher score being the individual perceives exercise more positively. When the Benefits Scale is used alone, the score range is between 29 to 116 with the higher the score being the individual perceives exercise more positively. When the Barriers Scale is used alone, the score range is between 14 to 56. The higher the score on the Barriers Scale, the greater the perception of barriers to exercise.
Time frame
Baseline, 6 weeks, 14 weeks, 22 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Palo Alto Veterans Institute for Research
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov