Peripheral Arterial Disease
Conditions
Brief summary
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Detailed description
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.
Interventions
OTHERExercise Intervention
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.
OTHERVAPAHCS Rehabilitation Core Components
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.
Sponsors
Patient-Centered Outcomes Research Institute
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Postmenopausal and not of child bearing capacity
Exclusion criteria
* Medically unstable patients * Recent MI within 3 months * Malignancy * Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l) * Alcoholism or other recreational drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to claudication pain | Baseline, 6 weeks, 14 weeks, 22 weeks | Time to initial onset of claudication pain with exercise treadmill test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-sensitivity C-reactive protein (hs-CRP) | Baseline, 6 weeks, 14 weeks, 22 weeks | High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw. |
| Urea Nitrogen | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain urea nitrogen in blood value. |
| Creatinine | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain creatinine in blood value. |
| eGFR | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain eGFR value. |
| Peak VO2 | 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. |
| 6-minute walk test (6MWT) | Baseline, 6 weeks, 14 weeks, 22 weeks | Total distance (meters) of walk in 6 minutes. |
| Walking Impairment Questionnaire (WIQ) | 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. |
| Peripheral Artery Questionnaire (PAQ) | 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. |
| Walking | Up to 22 weeks | Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device. |
| Energy expenditure | Up to 22 weeks | Energy expenditure will be quantified using fitness/health tracking device. |
| Chair raises | Baseline, 6 weeks, 14 weeks, 22 weeks | Number of repetitions completed within 60 seconds (46cm high seat). |
| Upper body strength | Baseline, 6 weeks, 14 weeks, 22 weeks | 1 repetition max for Chest Press. |
| Lower body strength | Baseline, 6 weeks, 14 weeks, 22 weeks | 1 repetition max for Leg Extension. |
| Hand grip strength | Baseline, 6 weeks, 14 weeks, 22 weeks | Maximum isometric strength will be measured using a hand grip dynamometer. |
| Insulin sensitivity | 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. |
| Lipid panel | Baseline, 6 weeks, 14 weeks, 22 weeks | Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw. |
| Sodium | Baseline, 6 weeks, 14 weeks, 22 weeks | Standard Chem 20 blood draw will be used to obtain sodium in blood value. |
| Homocysteine | Baseline, 6 weeks, 14 weeks, 22 weeks | Homocysteine will be assessed from blood draw. |
| Interleukin-6 (IL-6) | Baseline, 6 weeks, 14 weeks, 22 weeks | Interleukin-6 (IL-6) will be assessed from blood draw. |
| D-dimer | Baseline, 6 weeks, 14 weeks, 22 weeks | D-dimer will be assessed from blood draw. |
| Blood protein | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain blood protein value. |
| Albumin | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain albumin in blood value. |
| Calcium | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain calcium in blood value. |
| Potassium | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain potassium in blood value. |
| Chloride | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain chloride in blood value. |
| Carbon dioxide | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain carbon dioxide in blood value. |
| AST/GOTU/l | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain AST/GOTU/l in blood value. |
| ALT/GPT | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain ALT/GPT in blood value. |
| ALK Phosphatase | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain ALT/GPT in blood value. |
| Bilirubin | Baseline, 6 weeks, 14 weeks, 22 weeks | Blood draw will be used to obtain total bilirubin in blood value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise Benefits and Barriers Scale (EBBS) | 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. |
| Endothelial function | 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. |
| Ankle-brachial index (ABI) | 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. |
Countries
United States
Contacts
Primary ContactJonathan N Myers, PhD
Backup ContactCharles G Gronau, DCEP
Outcome results
None listed