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IRCT20251113067980N1 IRCT 2025-11-26 University of Tehran The effect of exercise on SMA type 3 patients. Safety, feasibility, and impact of ten weeks of supervised progressive resistance training of lower limbs on select functional, biomechanical, and blood biomarker factors in ambulatory adults with SMA type 3 and quality of life. 2025-12-05 anticipated 20 Complete https://irct.ir/trial/87530 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure age homogeneity within the study population, participants will be categorized into two age groups (18-29 years and 30+) and randomly assigned to either the control or intervention group using a manual lottery-based randomization method, ensuring a balanced age distribution for subsequent analyses. N/A Spinal Muscular Atrophy Type 3. Intervention 1: Intervention group: Intervention group: Progressive resistance exercises for the lower extremities in closed and open kinetic chains, supervised and for the first five weeks, twice a week, and for the second five weeks, three times a week, and individually at a specific time for each person, with a trainer-to-trainee ratio of two to one. Intervention 2: Control group: No intervention will be administered to the control group, and participants will continue their usual daily activities without restriction. Should the intervention prove effective and be confirmed by a specialist physician, the same protocol implemented in the research group will be offered under identical conditions and at the same location to members of the control group, on a voluntary basis and according to each participant’s preference. It should be noted that, for those control group participants who wish to receive the intervention after completion of the study, these services will be provided free of charge. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision regarding the sharing of individual participant data (IPD) has not yet been finalized. The research team will evaluate the feasibility, ethical considerations, and institutional policies related to IPD sharing after study completion. Any future plan for data sharing will be aligned with participant consent and applicable regulations.
public Shahram Khorshidi
Faculty of Sport Sciences and Health, University of Tehran, North Campus (Pardis-e Shomali), North Kargar Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1439813117 +98 21 8835 1730 shahram.khorshidi@ut.ac.ir Faculty of Sport Sciences and Health, University of Tehran scientific Khadijeh Sohrabi
Faculty of Sport Sciences and Health, University of Tehran, North Campus (Pardis-e Shomali), North Kargar Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1439813117 +98 21 8835 1730 khadije.sohrabi@ut.ac.ir Faculty of Sport Sciences and Health, University of Tehran Iran (Islamic Republic of) Age ≥18 years. Homozygous deletion of exon 7 of the SMN1 gene, confirmed by a test report and a specialist physician, indicating SMA type 3 Ability to walk independently for at least 25 meters informed consent 18 years no limit Both History of surgery or fracture in the past six months Moderate or severe scoliosis Serum creatine kinase (CK) levels of participants above 1000 units per liter in the past three months Non-ambulatory Under the age of eighteen years The presence of any concurrent chronic diseases such as diabetes, cardiovascular diseases, kidney disease, etc. Any type of SMA other than type 3 G12.1 Other inherited spinal muscular atrophy Rehabilitation N/A Intervention group: Intervention group: Progressive resistance exercises for the lower extremities in closed and open kinetic chains, supervised and for the first five weeks, twice a week, and for the second five weeks, three times a week, and individually at a specific time for each person, with a trainer-to-trainee ratio of two to one Control group: No intervention will be administered to the control group, and participants will continue their usual daily activities without restriction. Should the intervention prove effective and be confirmed by a specialist physician, the same protocol implemented in the research group will be offered under identical conditions and at the same location to members of the control group, on a voluntary basis and according to each participant’s preference. It should be noted that, for those control group participants who wish to receive the intervention after completion of the study, these services will be provided free of charge. Muscular strength, referring to maximum voluntary isometric contraction; Function, referring to the Timed Up and Go (TUG) test, the Six-Minute Walk Test (6MWT), and the Hammersmith Functional Motor Scale Expanded (HFMSE); Quality of Life Questionnaire; Blood Biomarkers including Interleukin 6, Interferon Gamma, Tumor Necrosis Factor Alpha. Timepoint: Measurement time points will be at the beginning of the study (before the start of the intervention) and at the end of the study. Method of measurement: Handheld dynamometer for muscle strength and for functional tests according to instructions. For quality of life, the SF-36 questionnaire, and for blood biomarkers, the ELISA method and the Zellbio Germany kit. Static balance, spatial and temporal gait parameters, dorsiflexion and plantar flexion angle, blood creatine kinase level, fatigue score. Timepoint: All variables at the beginning and end of the intervention were only creatine kinase levels at the beginning of the study, week 5, and at the end of the intervention. Method of measurement: For static balance, use a force plate; for spatiotemporal gait parameters, use a camera with a frame rate of 60 Hz; for dorsiflexion and plantar flexion angles, use a goniometer; for creatine kinase levels, use the ELISA method; for fatigue, use the Fatigue Severity Scale (FSS) questionnaire. University of Tehran Approved 2023-05-20 Ethics Committee in Research, Faculty of Physical Education and Sport Sciences, University of Tehran culty of Physical Education and Sport Sciences, University of Tehran, North Kargar Street, Central Campus, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)