Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
Study NCT ID:
NCT06785168
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2024-12-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2024-12-31', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of muscle strength', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'The change of gait speed', 'timeFrame': 'Baseline and 8 weeks', 'description': '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).'}, {'measure': 'The change of the five-times sit-to-stand test', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'chronic heart failure', 'machine-based resistance training', 'age over 60', 'outpatient'], 'conditions': ['Sarcopenia in Elderly', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 60 years old\n* 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.\n* Meet the diagnostic criteria of heart failure following ESC 2021.\n* Clearly understand the content and purpose of the study and sign the informed consent form.\n\nExclusion Criteria: There are contraindications for Exercise Testing in patients with stable heart failure according to ACSM 2022:\n\n* Early stage after acute coronary syndrome (within the first 2 days)\n* Unstable coronary artery disease\n* Decompensated heart failure\n* Acute venous thrombosis or recent arterial embolism (pulmonary or systemic)\n* Acute myocarditis, pericarditis, endocarditis\n* Aortic dissection of the valve\n* Severe symptomatic aortic stenosis\n* Acute systemic disease or fever\n* Uncontrolled or life-threatening atrial or ventricular arrhythmias (including new-onset atrial fibrillation or flutter)\n* Uncontrolled tachycardia (resting heart rate \\> 120 beats per minute)\n* Third-degree AV block\n* Uncontrolled diabetes\n* Symptomatic orthostatic hypotension (\\> 20 mmHg)\n* Gradually increasing fatigue during exercise or dyspnea at rest or with exertion within the past 3-5 days\n* Significant myocardial ischemia at low workloads \\< 2 METs or 50W\n* Relative contraindications according to ACSM 2022:\n* Weight gain ≥ 1.8 kg in the past 1-3 days\n* Simultaneous use of continuous or intermittent Dobutamine\n* Decrease in blood pressure with exercise\n* NYHA IV heart failure\n* Complex ventricular arrhythmias at rest or with exertion\n* Resting heart rate ≥ 100 bpm when lying down\n* Comorbidities that limit exercise\n* Severe obstructive hypertrophic cardiomyopathy\n* Have participated in a cardiovascular rehabilitation program within the last 6 months\n* Do not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT06785168', 'briefTitle': 'The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': 'The Effects of Machined Based Resistance Training in Older Patients With Chronic Heart Failure With Sarcopenia', 'orgStudyIdInfo': {'id': '24590-DHYD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care Group (US)', 'description': '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.'}, {'type': 'OTHER', 'label': 'Machine-based Resistance Training Group', 'description': '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', 'interventionNames': ['Other: Machine-based Resistance Training']}], 'interventions': [{'name': 'Machine-based Resistance Training', 'type': 'OTHER', 'otherNames': ['M-RT', 'A'], 'description': '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.', 'armGroupLabels': ['Machine-based Resistance Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'CONTACT', 'email': 'ndpkieu.ncs24@ump.edu.vn', 'phone': '(+84)984701516'}, {'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Military Hospital 175', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'zip': '700000', 'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'CONTACT', 'email': 'ndpkieu.ncs24@ump.edu.vn', 'phone': '(+84)984701516'}, {'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'CONTACT', 'email': 'ndpkieu.ncs24@ump.edu.vn', 'phone': '(+84)984701516'}], 'overallOfficials': [{'name': 'Nguyen Dang P Kieu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information Security'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kieu Nguyen Dang Phuong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Kieu Nguyen Dang Phuong', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}