Sarcopenia in ElderlyNCT06785168
Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure
A study testing Machine-based Resistance Training in people with Sarcopenia in Elderly and Chronic Heart Failure, run by Kieu Dang Phuong Nguyen at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Chronic Heart Failure
- What is being tested?
- Machine-based Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesVietnam
- Study dates
- 27 Jan 2025to 4 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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)
Show all 31Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Military Hospital 175
Ho Chi Minh City, 700000
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sarcopenia in Elderly, Chronic Heart Failure
- Being tested
- Machine-based Resistance Training
- Keywords
- sarcopenia, chronic heart failure, machine-based resistance training, age over 60, outpatient
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-based Resistance TrainingOther
Also called M-RT, A
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Machine-based Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
The change of the five-times sit-to-stand test
The five-times sit-to-stand test is timed in seconds. Participants will sit in a chair without armrests, ensuring their back and lower legs are straight, with their arms crossed over their chest. They will then stand up and sit down as quickly as possible. The time is recorded using a stopwatch, beginning when the participants stand for the first time and ending when they sit down for the fifth time.
Measured: Baseline and 8 weeks
The change of gait speed
Gait speed is measured in meters per second. Participants will walk at their usual pace over a 6-meter distance, and gait speed will be calculated using the formula v = s/t, where t is the time in seconds and s is the distance (6 meters).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start27 Jan 2025
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kieu Dang Phuong Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kieu Dang Phuong Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Nguyen Dang P Kieu, M.D., Study chair, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785168
- Sponsor's protocol ID
- 2463/DHYD-HDDD
- Status last verified
- Aug 2026
- First submitted
- 31 Dec 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information Security
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06785168
- Acronym / sponsor ID
- 2463/DHYD-HDDD
- Conditions
- Sarcopenia in Elderly, Chronic Heart Failure
- Keywords
- sarcopenia, chronic heart failure, machine-based resistance training, age over 60, outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kieu Dang Phuong NguyenUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Machine-based Resistance TrainingThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine-based Resistance TrainingAlso: M-RT, AThe 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. | Other | Machine-based Resistance Training Group |
Primary outcome
The change of muscle strength
Time frame: 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.
2 secondary outcomes
The change of the five-times sit-to-stand test
Time frame: Baseline and 8 weeks
The change of gait speed
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Information Security
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen Dang P Kieu, M.D. study chair
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Machine-based Resistance Training in people with Sarcopenia in Elderly and Chronic Heart Failure, run by Kieu Dang Phuong Nguyen at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of muscle strength (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.