臨床研究等提出・公開システム

Randmized Controlled Trial of Prehabilitation in Patients Undergoing Cardiovascular Surgery

Randomized Controlled Trial of Prehabilitation Using Protein Supplementation and Grip Strength Training Before Cardiovascular Surgery

Miyajima Saki

Nara Medical University

840 Shijo-cho, Kashihara, Nara 634-8522 Japan

K187665@naramed-u.ac.jp

Miyajima Saki

Nara Medical University

840 Shijo-cho, Kashihara, Nara 634-8522 Japan

+81-744-29-8902

K187665@naramed-u.ac.jp

Recruiting

July. 01, 2026

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

prevention purpose

1.Patients scheduled to undergo cardiovascular surgery requiring cardiopulmonary bypass or off-pump coronary artery bypass grafting (OPCAB) at Nara Medical University Hospital or Saiseikai Kumamoto Hospital.
2.Patients with cardiovascular diseases classified as New York Heart Association (NYHA) functional class1or 2.
3.Patients aged 18 years or older, regardless of sex.
4.Patients who can provide written informed consent.
5.Patients who can complete a prehabilitation intervention period of at least 14 days before surgery.

1.Patients undergoing emergency surgery.
2.Patients with psychiatric disorders who are currently receiving treatment from a psychiatrist.
3. Patients unable to communicate in Japanese in daily conversation.
4.Patients with upper extremity paralysis or other conditions that make grip strength training or grip strength measurement impossible.
5.Patients with a severe allergy to dairy products.
6.Patients with severe obesity (BMI >=35 kg/m2) or poor glycemic control (HbA1c >= 8.0%) for whom nutritional supplementation is considered inappropriate or difficult.
7.Patients with chronic kidney disease (CKD) stage 4 or 5 for whom protein supplementation is considered inappropriate or difficult.
8.Patients with New York Heart Association (NYHA) functional class 3 or 4 heart failure.
9.Patients with a history suggestive of symptomatic cerebral ischemia, such as syncope during exercise.
10.Patients with a history of admission to an intensive care unit (ICU), including at another institution, within the past year.
11.Patients who withdraw their informed consent after enrollment.
12.Patients whose scheduled surgery is postponed by 7 days or more after enrollment, regardless of whether the reason is patient-related or hospital-related.
13.Patients who undergo surgery with an intervention period of less than 14 days due to any reason.

Both

Angina or coronary artery stenosis, Valvular disease,Thoracic aortic aneurysm, Adult congenita

Grip strength training and protein load

- Angina or coronary artery stenosis - Valvular disease - Thoracic aortic aneurysm - Adult congenita

prehabilitaion

WHODAS2.0

QoR-15,Postoperative delirium,Postoperative complications,Length of hospital stay

+81-744-29-8835

May. 12, 2026

none