Clinical trial NCT06785168: The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients
Official title: The Effects of Machined Based Resistance Training in Older Patients With Chronic Heart Failure With Sarcopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia in Elderly
Chronic Heart Failure
Keywords: sarcopenia
chronic heart failure
machine-based resistance training
age over 60
outpatient
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 146
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria: 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

Primary outcomes:
measure: The change of muscle strength
timeFrame: Baseline and 8 weeks
measure: The change of gait speed
timeFrame: Baseline and 8 weeks
measure: The change of the five-times sit-to-stand test
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Military Hospital 175
city: Ho Chi Minh
country: Vietnam
facility: University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Nguyen Dang P Kieu, M.D.
role: STUDY_CHAIR
References: