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NCT Number: NCT06566976

Prehabilitation and Rehabilitation in PAD

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

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

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

VAPAHCS Rehabilitation Core Components

Other

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.

Primary outcomes

  1. Time to claudication pain

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Time to initial onset of claudication pain with exercise treadmill test.

Secondary outcomes

  1. Peak VO2

    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.

  2. 6-minute walk test (6MWT)

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Total distance (meters) of walk in 6 minutes.

  3. Walking Impairment Questionnaire (WIQ)

    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.

  4. Peripheral Artery Questionnaire (PAQ)

    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.

  5. Walking

    Time frame: Up to 22 weeks

    Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device.

  6. Energy expenditure

    Time frame: Up to 22 weeks

    Energy expenditure will be quantified using fitness/health tracking device.

  7. Chair raises

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Number of repetitions completed within 60 seconds (46cm high seat).

  8. Upper body strength

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    1 repetition max for Chest Press.

  9. Lower body strength

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    1 repetition max for Leg Extension.

  10. Hand grip strength

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Maximum isometric strength will be measured using a hand grip dynamometer.

  11. Insulin sensitivity

    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.

  12. Lipid panel

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.

  13. Sodium

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Standard Chem 20 blood draw will be used to obtain sodium in blood value.

  14. Homocysteine

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Homocysteine will be assessed from blood draw.

  15. High-sensitivity C-reactive protein (hs-CRP)

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.

  16. Interleukin-6 (IL-6)

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Interleukin-6 (IL-6) will be assessed from blood draw.

  17. D-dimer

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    D-dimer will be assessed from blood draw.

  18. Blood protein

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain blood protein value.

  19. Albumin

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain albumin in blood value.

  20. Calcium

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain calcium in blood value.

  21. Potassium

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain potassium in blood value.

  22. Chloride

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain chloride in blood value.

  23. Carbon dioxide

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain carbon dioxide in blood value.

  24. AST/GOTU/l

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain AST/GOTU/l in blood value.

  25. ALT/GPT

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain ALT/GPT in blood value.

  26. ALK Phosphatase

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain ALT/GPT in blood value.

  27. Bilirubin

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain total bilirubin in blood value.

  28. Urea Nitrogen

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain urea nitrogen in blood value.

  29. Creatinine

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain creatinine in blood value.

  30. eGFR

    Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks

    Blood draw will be used to obtain eGFR value.

Other outcomes

  1. Endothelial function

    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.

  2. Ankle-brachial index (ABI)

    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.

  3. Exercise Benefits and Barriers Scale (EBBS)

    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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)

Acronym: PREPARE-IT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

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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