Prehabilitation and Rehabilitation in PAD
NCT Number: NCT06566976
Acronym: PREPARE-IT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Arterial Disease
Interventions: OTHER: Exercise Intervention|OTHER: VAPAHCS Rehabilitation Core Components
Sponsor: Palo Alto Veterans Institute for Research
Collaborators: Patient-Centered Outcomes Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-07
Completion Date: 2027-07-25
Locations: VA Palo Alto Health Care System, Palo Alto, California, 94304, United States

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

Primary Outcome Measures: Time to claudication pain, Time to initial onset of claudication pain with exercise treadmill test., Baseline, 6 weeks, 14 weeks, 22 weeks
Secondary Outcome Measures: Peak VO2, Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses., Baseline, 6 weeks, 14 weeks, 22 weeks|6-minute walk test (6MWT), Total distance (meters) of walk in 6 minutes., Baseline, 6 weeks, 14 weeks, 22 weeks|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., Baseline, 6 weeks, 14 weeks, 22 weeks|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., Baseline, 6 weeks, 14 weeks, 22 weeks|Walking, Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device., Up to 22 weeks|Energy expenditure, Energy expenditure will be quantified using fitness/health tracking device., Up to 22 weeks|Chair raises, Number of repetitions completed within 60 seconds (46cm high seat)., Baseline, 6 weeks, 14 weeks, 22 weeks|Upper body strength, 1 repetition max for Chest Press., Baseline, 6 weeks, 14 weeks, 22 weeks|Lower body strength, 1 repetition max for Leg Extension., Baseline, 6 weeks, 14 weeks, 22 weeks|Hand grip strength, Maximum isometric strength will be measured using a hand grip dynamometer., Baseline, 6 weeks, 14 weeks, 22 weeks|Insulin sensitivity, Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score., Baseline, 6 weeks, 14 weeks, 22 weeks|Lipid panel, Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw., Baseline, 6 weeks, 14 weeks, 22 weeks|Sodium, Standard Chem 20 blood draw will be used to obtain sodium in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Homocysteine, Homocysteine will be assessed from blood draw., Baseline, 6 weeks, 14 weeks, 22 weeks|High-sensitivity C-reactive protein (hs-CRP), High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw., Baseline, 6 weeks, 14 weeks, 22 weeks|Interleukin-6 (IL-6), Interleukin-6 (IL-6) will be assessed from blood draw., Baseline, 6 weeks, 14 weeks, 22 weeks|D-dimer, D-dimer will be assessed from blood draw., Baseline, 6 weeks, 14 weeks, 22 weeks|Blood protein, Blood draw will be used to obtain blood protein value., Baseline, 6 weeks, 14 weeks, 22 weeks|Albumin, Blood draw will be used to obtain albumin in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Calcium, Blood draw will be used to obtain calcium in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Potassium, Blood draw will be used to obtain potassium in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Chloride, Blood draw will be used to obtain chloride in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Carbon dioxide, Blood draw will be used to obtain carbon dioxide in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|AST/GOTU/l, Blood draw will be used to obtain AST/GOTU/l in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|ALT/GPT, Blood draw will be used to obtain ALT/GPT in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|ALK Phosphatase, Blood draw will be used to obtain ALT/GPT in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Bilirubin, Blood draw will be used to obtain total bilirubin in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Urea Nitrogen, Blood draw will be used to obtain urea nitrogen in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|Creatinine, Blood draw will be used to obtain creatinine in blood value., Baseline, 6 weeks, 14 weeks, 22 weeks|eGFR, Blood draw will be used to obtain eGFR value., Baseline, 6 weeks, 14 weeks, 22 weeks
Other Outcome Measures: 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., Baseline, 6 weeks, 14 weeks, 22 weeks|Ankle-brachial index (ABI), Using a standard brachial artery cuff method with a Doppler ultrasound probe at the posterior tibial artery to determine ABI., Baseline, 6 weeks, 14 weeks, 22 weeks|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., Baseline, 6 weeks, 14 weeks, 22 weeks