NCT Number: NCT06566976
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
Location status: Recruiting
Charles G Gronau, DCEP
CONTACT
Charles G Gronau, DCEP
SUB_INVESTIGATOR
Jonathan N Myers, PhD
CONTACT
650-493-5000 ext. 64661
Jonathan N Myers, PhD
PRINCIPAL_INVESTIGATOR
Khin N Chan, MD
SUB_INVESTIGATOR
Pallavi Gautam, MPT
SUB_INVESTIGATOR
Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.
Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.
Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Exercise Therapy
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.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Time to initial onset of claudication pain with exercise treadmill test.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
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 weeks
Total distance (meters) of walk in 6 minutes.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
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 weeks
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: Up to 22 weeks
Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device.
Time frame: Up to 22 weeks
Energy expenditure will be quantified using fitness/health tracking device.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Number of repetitions completed within 60 seconds (46cm high seat).
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
1 repetition max for Chest Press.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
1 repetition max for Leg Extension.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Maximum isometric strength will be measured using a hand grip dynamometer.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Standard Chem 20 blood draw will be used to obtain sodium in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Homocysteine will be assessed from blood draw.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Interleukin-6 (IL-6) will be assessed from blood draw.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
D-dimer will be assessed from blood draw.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain blood protein value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain albumin in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain calcium in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain potassium in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain chloride in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain carbon dioxide in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain AST/GOTU/l in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain ALT/GPT in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain ALT/GPT in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain total bilirubin in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain urea nitrogen in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain creatinine in blood value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood draw will be used to obtain eGFR value.
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
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 weeks
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 weeks
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.
Contact information is provided by the study sponsor or research team.
Palo Alto Veterans Institute for Research
Other
Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)
Acronym: PREPARE-IT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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