The effect of Beta-Hydroxy beta-Methyl Butyrate calcium combined with exercise therapy in patients with heart disiase(The effect of HMB-Ca combined with exercise therapy in patients with heart disiase)

JRCT ID: jRCTs031220139

Registered date:16/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart disease (myocardial infarction or angina, post-open heart surgery, chronic heart failure)
• Date of first enrollment: 16/06/2022
• Target sample size: 52
• Study type: Interventional
• Intervention(s): Use 1.5 g of HMB-Ca tablets. The study period is 60 days from the start of cardiac rehabilitation. 52 patients were randomly divided into 2 groups, HMB-Ca group consuming 1.5 g of 6 tablets of HMB-C a once daily for 60 days, and Placebo group consuming1.2 g of reduced maltose once daily for 60 days. Exercise therapy was performed in both groups, with supervised exercise therapy (1-5 times a week) combined with unsupervised exercise therapy (1-2 times a week), and exercise therapy for 30 minutes each, for a total of 3 times (at least) a week.

Outcome(s)

• Primary Outcome: Quadriceps muscle strength

Secondary Outcome

grip strength
lower limb extension strength
Skeletal muscle mass
quadriceps muscle thickness
Energy consumption (physical activity)
Short Physical Performance Battery(SPPB)
10-m timed gait test
SF-12v2 Japanese edition
cardiopulmonart exercise testing(peakVO2,Peak-Load,AT)
albumin
total protein
brain natriuretic peptide
creatinine
blood urea nitrogen
estimated glomerular filtration rate
cystatin C
calcium
creatine kinase
CK-MB
microRNA(miR-181a, miR-181b, miR-181c, miR-484)
BDNF(Brain Derived Neurotrophic Factor)
nutritional components in urine and dietary survey

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who newly started outpatient cardiac rehabilitation at Showa University Fujigaoka Rehabilitation Hospital
2) Patients with heart disease (myocardialinfarction or angina, post-open heart surgery, chronic heart failure) as the name of rehabilitation disease
3) Patients who voluntarily consented to the document after receiving an explanation using the patient's document when participating in this study.
4) Patients are 40 years of age or more.

Exclude criteria

1) Patients with severe renal dysfunction (eGFR <30), dialysis patients
2) Patients who have difficulty in continuous exercise therapy for 20 minutes or more due to factors other than heart disease
3) Patients with depression / schizophrenia / dementia
4) Patients with dysphagia
5) Patients with untreated cardiovascular diseaseand limited exercise therapy
6) Patients with restricted energy and protein intake due to diabetes and renal dysfunction
7) Patients who had not been hospitalized for heart disease within 6 months and had undergone outpatient cardiac rehabilitation
8) Other patients who the principal investigator deems inappropriate as a subject

Related Information

• Primary Sponsor: Hiroo Ichikawa
• Secondary Sponsor: Ikeda Takashi
• Source(s) of Monetary Support: JSPS KAKENHI Grant