Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- The change of muscle strength
研究概览
简要总结
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.
详细描述
The participants will be randomly assigned to two groups: One group received machine-based resistance training (MRT) at the hospital, while the other group received usual care (US). The outcomes will be measured in the participants after 8 weeks including handgrip strength, gait speed, performance on the five-times sit-to-stand test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <5.4 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
- •Clearly understand the content and purpose of the study and sign the informed consent form.
排除标准
- •There are contraindications for Exercise Testing in patients with stable heart failure according to ACSM 2022:
- •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
- •Relative contraindications according to ACSM 2022:
- •Weight gain ≥ 1.8 kg in the past 1-3 days
- •Simultaneous use of continuous or intermittent Dobutamine
- •Decrease in blood pressure with exercise
- •NYHA IV heart failure
- •Complex ventricular arrhythmias at rest or with exertion
- •Resting heart rate ≥ 100 bpm when lying down
- •Comorbidities that limit exercise
- •Severe obstructive hypertrophic cardiomyopathy
- •Have participated in a cardiovascular rehabilitation program within the last 6 months
- •Do not agree to participate in the study
研究组 & 干预措施
Usual Care Group (US)
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
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
干预措施: Machine-based Resistance Training (Other)
结局指标
主要结局
The change of muscle strength
时间窗: Baseline and 8 weeks
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.
次要结局
- The change of the five-times sit-to-stand test(Baseline and 8 weeks)
- The change of gait speed(Baseline and 8 weeks)
研究者
Kieu Dang Phuong Nguyen
PhD student
University of Medicine and Pharmacy at Ho Chi Minh City