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Impact of resistance exercise rehabilitation and whey protein supplementation in elderly patients with heart failure with preserved ejection fraction and sarcopenia: a study protocol for a prospective randomized controlled trial

A prospective randomized clinical study of remote monitoring system for the elderly patients with heart failure and sarcopenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061069
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with preserved ejection fraction and sarcopenia

Interventions

Resistance training group:Basic intervention+Resistance training
Resistance training+whey protein group:Basic intervention + Resistance training + Whey protein supplementation

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 65 years old; 2. Meet the diagnostic criteria of sarcopenia (2019 AWGS2 standard, myopenia can be diagnosed once meeting (1)+(2) or (1)+(3) or (1)+(2)+(3)) (1) Appendicular skeletal muscle mass (ASM): dual-energy X-ray absorptiometry (DXA) (male = 12s; 3. Meet the diagnostic criteria of HFpEF (2018 Chinese guidelines for the diagnosis and treatment of heart failure): (1) Typical symptoms and/or signs; (2) Left ventricular ejection fraction >= 50%; (3) Elevated natriuretic peptide levels (BNP >= 35pg/mL or NT-proBNP >= 125 pg/mL), and meet at least 1 of the following: 1) Left ventricular hypertrophy and/or Left atrial enlargement; 2) Diastolic function abnormality; (4) Exclude non-cardiac diseases that cause similar symptoms; (5) NYHA functional class I and II 3. Be able to understand and sign informed consent form.

Exclusion criteria

Exclusion criteria: 1. Aerobic exercise and resistance exercise cannot be carried out due to physical disability; 2. Daily activities cannot be carried out due to cardiopulmonary diseases; 3. Other clinical trial drugs were taken or in other medical device trial within 30 days before admission; 4. II or III degree heart block or sick sinus syndrome without permanent pacemaker implantation; need implantable device therapy for heart failure; 5. Uncontrolled hypertension or postural hypotension; 6. ACS was happened in 3 months before admission, Coronary revascularisation is planned; 7. Impaired renal function (estimated glomerular filtration rate < 60ml/min/1.73 m2); 8. Impaired hepatic function (serum transaminase level 2 times higher than the normal reference value); 9. Cancer or other systemic diseases with an expected survival of less than 12 months; 10. Allergies to milk proteins; 11. Unable to participate in this study after the clinical evaluation by investigators.

Design outcomes

Primary

MeasureTime frame
6min walk test;

Secondary

MeasureTime frame
handgrip strength;Short Physical Performance Battery;Appendicular skeletal muscle mass;LVEF;Natriuretic peptide;Minnesota Living with Heart Failure Questionnaire;Mini Nutritional Assessment-Short Form;Mini Nutritional Assessment-Short Form;

Countries

China

Contacts

Public ContactZheng Xiaoyun

China-Japan Friendship Hospital

atfcn@126.com+86 13683331832

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026