The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients

NCT ID: NCT06785168

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Sarcopenia in Elderly Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Machine-based Resistance Training

Intervention Type 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.

Interventions

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Machine-based Resistance Training

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.

Intervention Type OTHER

Other Intervention Names

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M-RT A

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kieu Nguyen Dang Phuong

OTHER

Sponsor Role lead

Responsible Party

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Kieu Nguyen Dang Phuong

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nguyen Dang P Kieu, M.D.

Role: STUDY_CHAIR

University of Medicine and Pharmacy at Ho Chi Minh City

Locations

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Military Hospital 175

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Nguyen Dang P Kieu, M.D.

Role: CONTACT

(+84)984701516

Facility Contacts

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Nguyen Dang P Kieu, M.D.

Role: primary

(+84)984701516

Nguyen Dang P Kieu, M.D.

Role: primary

(+84)984701516

Other Identifiers

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24590-DHYD

Identifier Type: -

Identifier Source: org_study_id

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