Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure

NCT06785168 | Recruiting DMC

• 1 other identifier: 2463/DHYD-HDDD
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

Conditions

Sarcopenia in Elderly; Chronic Heart Failure

Keywords

sarcopenia; chronic heart failure; machine-based resistance training; age over 60; outpatient

Outcome Measures

Primary Outcomes (1)

• The change of muscle strength

  The change of muscle strength will be evaluated using handgrip strength, measured in kilograms. Each hand will be tested twice with a Jamar Hydraulic Hand Dynamometer (USA), and the highest value will be recorded.

  Baseline and 8 weeks

Secondary Outcomes (2)

• The change of the five-times sit-to-stand test

  Baseline and 8 weeks

• The change of gait speed

  Baseline and 8 weeks

Study Arms (2)

Usual Care Group (US)

NO INTERVENTION

The participants will receive HF treatment as prescribed by cardiologists based on clinical guidelines. If participants have any additional medical conditions, their existing medications or treatments should continue. The prescribed medications should remain the same throughout the trial, with dosage adjustments only made if adverse events occur. The participants are also asked to maintain their usual physical activity, exercise routines, and dietary habits, without making changes outside of the study intervention. Researchers will contact incorrectly by phone weekly.

Machine-based Resistance Training Group

OTHER

The participants will receive HF treatment as prescribed by cardiologists. If participants have any additional medical conditions, their existing medications or treatments should continue. They are also asked to maintain their usual physical activity, exercise routines, and dietary habits, without making changes outside of the study intervention. And they will train 3 nonconsecutive days/week during 8 weeks as follows: leg press and calf raise by Proxomed Compass 540 (Germany); leg curl, chest press, push up, seated row by HUR

Other: Machine-based Resistance Training

Interventions

Machine-based Resistance Training OTHER

The participants will receive HF treatment as prescribed by cardiologists. If participants have any additional medical conditions, their existing medications or treatments should continue. They are also asked to maintain their usual physical activity, exercise routines, and dietary habits, without making changes outside of the study intervention. At the beginning, patients participating in resistance training should complete a pretest of one-repetition maximum (1-RM) to assess muscle strength, which will be used by a professional physical therapist to develop an individualized prescription. The specific movements are as follows: (1) leg press and (2) calf raise by Proxomed Compass 540 (Germany); (3) leg curl, (4) chest press, (5) push up, (6) seated row by HUR machine (US). During the 8 weeks, subjects will train 3 non-consecutive days/week with intensity 30%1-RM to 60% 1-RM, 3 sets/one excercise with 8-12 repetitions.

Also known as: M-RT, A

Machine-based Resistance Training Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 60 years old
• Meet the diagnostic criteria of 2019 AWGS2 sarcopenia, 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 \<7.0 kg/m², female \<5.7 kg/m²). (2) Muscle strength: handgrip strength (male \<28.0 kg, female \<18.0 kg). (3) Physical performance: 6-meter walking speed \<1.0 m/s.
• Meet the diagnostic criteria of heart failure following ESC 2021.
• Clearly understand the content and purpose of the study and sign the informed consent form.

You may not qualify if:

• Early stage after acute coronary syndrome (within the first 2 days)
• Unstable coronary artery disease
• Decompensated heart failure
• Acute venous thrombosis or recent arterial embolism (pulmonary or systemic)
• Acute myocarditis, pericarditis, endocarditis
• Aortic dissection of the valve
• Severe symptomatic aortic stenosis
• Acute systemic disease or fever
• Uncontrolled or life-threatening atrial or ventricular arrhythmias (including new-onset atrial fibrillation or flutter)
• Uncontrolled tachycardia (resting heart rate \> 120 beats per minute)
• Third-degree AV block
• Uncontrolled diabetes
• Symptomatic orthostatic hypotension (\> 20 mmHg)
• Gradually increasing fatigue during exercise or dyspnea at rest or with exertion within the past 3-5 days
• Significant myocardial ischemia at low workloads \< 2 METs or 50W

Sponsors & Collaborators

• Kieu Nguyen Dang Phuong: lead

Study Sites (2)

Military Hospital 175

Ho Chi Minh City, 700000, Vietnam

RECRUITING

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nguyen Dang P Kieu, M.D.

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Central Study Contacts

Nguyen Dang P Kieu, M.D.

CONTACT

(+84)984701516; ndpkieu.ncs24@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 21, 2025
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)