- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785168
Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure
April 25, 2026 updated by: Kieu Nguyen Dang Phuong
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
146
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nguyen Dang P Kieu, M.D.
- Phone Number: (+84)984701516
- Email: ndpkieu.ncs24@ump.edu.vn
Study Locations
-
-
-
Ho Chi Minh City, Vietnam, 700000
- Recruiting
- University of Medicine and Pharmacy at Ho Chi Minh City
-
Contact:
- Nguyen Dang P Kieu, M.D.
- Phone Number: (+84)984701516
- Email: ndpkieu.ncs24@ump.edu.vn
-
Principal Investigator:
- Nguyen Dang P Kieu, M.D.
-
Ho Chi Minh City, Vietnam, 700000
- Recruiting
- Military Hospital 175
-
Contact:
- Nguyen Dang P Kieu, M.D.
- Phone Number: (+84)984701516
- Email: ndpkieu.ncs24@ump.edu.vn
-
Principal Investigator:
- Nguyen Dang P Kieu, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Other: 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
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of gait speed
Time Frame: Baseline and 8 weeks
|
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).
|
Baseline and 8 weeks
|
|
The change of the five-times sit-to-stand test
Time Frame: Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nguyen Dang P Kieu, M.D., University of Medicine and Pharmacy at Ho Chi Minh City
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 24, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
December 31, 2024
First Submitted That Met QC Criteria
January 17, 2025
First Posted (Actual)
January 21, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 25, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2463/DHYD-HDDD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Information Security
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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