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IRCT20180501039501N1 IRCT 2026-09-24 Imam Khomeini International University of Qazvin The effect of resistance training, electrical muscle stimulation (EMS), and vitamin D supplementation on sarcopenia in patients with heart failure with reduced ejection fraction The effect of resistance training, electrical muscle stimulation (EMS) and vitamin D supplementation on the regulation of microRNAs miR-486 and miR-206, serum concentrations of insulin-like growth factor 1 (IGF-1), myostatin and fibroblast growth factor 21 (FGF-21), and physical performance indices in patients with heart failure with reduced ejection fraction and sarcopenia 2026-09-23 anticipated 25 Recruiting https://irct.ir/trial/92782 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Blinding description: SubjectGiven the nature of the interventions in this study (resistance training and Electromyostimulation - EMS), blinding the participants and the training instructors is not feasible due to the overt and tangible nature of the interventions. However, to minimize potential bias and enhance the scientific validity of the study, blinding is strictly implemented at the following levels: Blinding of Outcome Assessors: All individuals responsible for phlebotomy, laboratory biochemical analysis, and physical performance testing are completely blinded to the participants’ group assignments. Blood samples will be sent to the laboratory using a coding system to prevent any potential bias in the results. Blinding of Data Analyst: The statistician performing the data analysis will receive the data labeled with group codes (e.g., Group A, B, and C) and will remain blinded to the identity of the intervention groups until the data analysis phase is finalized. Therefore, the present study is designed as a single-blind trial, with a focus on blinding the assessment and data analysis teams to prevent the influence of potential biases on the reported outcomes.s. 3 Heart failure patients with reduced ejection fraction and sarcopenia. Intervention 1: Control group: Received usual medical care and cardiac rehabilitation according to the center's program, without resistance training or EMS; along with a placebo and vitamin D supplementation (if foreseen in the protocol). Intervention 2: Intervention group: Vitamin D supplementation groupReceived usual medical care along with vitamin D supplementation at the dose and duration specified in the protocol; without performing resistance training and EMS. Intervention 3: Intervention group: Resistance Training (RT) groupReceived usual medical care along with a gradual, clinically appropriate resistance training program, supervised by the cardiac rehabilitation team; no vitamin D supplementation or EMS. Intervention 4: Intervention group: Electrical Muscle Stimulation (EMS) group,Receiving usual medical care plus electrical muscle stimulation with standard parameters tailored to the patient's condition, under the supervision of a medical and cardiac rehabilitation team; without resistance training and vitamin D supplementation. Intervention 5: Intervention group: Resistance training + EMS + Vitamin D supplementation groupReceived usual medical care along with implementing a gradual resistance training program and vitamin D supplementation, according to the dose and duration specified in the protocol; under the supervision of the cardiac and medical rehabilitation team. Yes - There is a plan to make this available What will be shared: De-identified individual participant data will be available, including baseline demographic and clinical characteristics, intervention group allocation, primary outcome data (relative expression of miR-486 and miR-206, and serum concentrations of IGF-1, myostatin, and FGF-21), secondary outcome data (handgrip strength, gait speed, Berg Balance Scale score, and serum 25(OH)D level), and the data dictionary. All direct identifiers and potentially identifying information will be removed before data sharing. The study protocol and statistical analysis plan will also be available upon request. When: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years after the publication date. To whom: Researchers affiliated with universities, research institutions, healthcare centers, or other recognized scientific organizations may submit a data-access request. Applicants must have relevant scientific qualifications and a methodologically sound research or analysis proposal. Conditions: Data may be used only for scientific analyses relevant to the study objectives, valid secondary research, meta-analyses, or replication and verification of the study findings. Access requests must include the research objective, analysis plan, research-team details, and a commitment to confidentiality. Access will be conditional upon approval by the principal investigator, compliance with research ethics requirements, execution of a data-use agreement, and agreement not to attempt re-identification of participants or transfer data to third parties. Commercial use, redistribution of raw data, or use beyond the approved objectives will not be permitted. Where to obtain: Applicants should submit a written request to the principal investigator of the study. Requests may be submitted and followed up through the principal investigator’s official email address: Principal Investigator: [Samaneh Ebrahimi] Email: [ebrahimi.mailbox@gmail.com] Affiliation: Rajaie Cardiovascular Medical and Research Center, Tehran, Iran. How to obtain: Applicants must submit a written request including the study title and objective, a brief research protocol, proposed analysis plan, research-team details, institutional affiliation, and ethics approval when required. The request will be reviewed for scientific relevance, feasibility, ethical considerations, and protection of confidentiality. A decision will be communicated within a maximum of 30 working days. If approved, and after execution of a data-use agreement, the agreed de-identified data files and supporting documents will be provided through a secure transfer method. Comments: Shared data will contain no direct personal identifiers. Given the small sample size and the sensitivity of clinical information from patients with heart failure, some potentially identifying variables may be removed, aggregated, or restricted to minimize the risk of indirect participant re-identification.
public Samaneh Ebrahimi
**No. 7, Unit 7, 8th East Alley, North Varzi Street, West Ferdows Boulevard (Nasser Hejazi), Tehran, Iran.**
TEHRAN Iran (Islamic Republic of) 1483795468 +98 21 4415 0650 ebrahimi.mailbox@gmail.com Imam Khomeini International University of Qazvin scientific Khadija Irandoust
**No. 7, Unit 7, 8th East Alley, North Varzi Street, West Ferdows Boulevard (Nasser Hejazi), Tehran, Iran.**
TEHRAN Iran (Islamic Republic of) 1483795468 +98 21 4415 0650 ebrahimi.mailbox@gmail.com Imam Khomeini International University of Qazvin Iran (Islamic Republic of) Sarcopenia in patients with heart failure with reduced ejection fraction no limit no limit Both (I00-I99) IX Diseases of the circulatory system Other Other Other Other Other Control group: Received usual medical care and cardiac rehabilitation according to the center's program, without resistance training or EMS; along with a placebo and vitamin D supplementation (if foreseen in the protocol). Intervention group: Vitamin D supplementation groupReceived usual medical care along with vitamin D supplementation at the dose and duration specified in the protocol; without performing resistance training and EMS. Intervention group: Resistance Training (RT) groupReceived usual medical care along with a gradual, clinically appropriate resistance training program, supervised by the cardiac rehabilitation team; no vitamin D supplementation or EMS Intervention group: Electrical Muscle Stimulation (EMS) group,Receiving usual medical care plus electrical muscle stimulation with standard parameters tailored to the patient's condition, under the supervision of a medical and cardiac rehabilitation team; without resistance training and vitamin D supplementation. Intervention group: Resistance training + EMS + Vitamin D supplementation groupReceived usual medical care along with implementing a gradual resistance training program and vitamin D supplementation, according to the dose and duration specified in the protocol; under the supervision of the cardiac and medical rehabilitation team. Relative expression level of miR-486 in blood samples, by RT-qPCR method. Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: RT-qPCR assay. Relative expression level of miR-206 in blood samples. Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: RT-qPCR assay. Serum concentration of insulin-like growth factor-1 (IGF-1). Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: measured by ELISA. Serum concentration of myostatin. Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: measured by ELISA. Serum concentration of fibroblast growth factor-21 (FGF-21). Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: measured by ELISA. Relative expression level of miR-486 in blood samples. Timepoint: at the end of week 12. Method of measurement: measured by RT-qPCR. Relative expression level of miR-206+ in blood samples. Timepoint: at the end of week 12. Method of measurement: measured by RT-qPCR. Serum concentration of insulin-like growth factor-1 (IGF-1). Timepoint: at the end of the 12th week. Method of measurement: measured by ELISA. Serum myostatin concentration. Timepoint: at the end of week 12. Method of measurement: measured by ELISA. Serum concentration of fibroblast growth factor-21 (FGF-21). Timepoint: at the end of the 12th week. Method of measurement: measured by ELISA. Imam Khomeini International University of Qazvin Approved 2026-06-07 Research Ethics Working Group/Committee, Qazvin University of Medical Sciences No. 7. Unit 7. East 8th Alley. North Varzi Street. West Ferdows Boulevard. Tehran Qazvin Qazvin Iran (Islamic Republic of)