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.

This study evaluates the safety and feasibility of progressive lower limb resistance training in individuals with SMA type 3. It also examines effects on functional performance, static balance, gait parameters, ankle joint mobility, isometric muscle strength, quality of life, fatigue (via FSS), and blood biomarkers including creatine kinase, IL-6, IFN-γ, and TNF-α.

In this study, two groups will be divided into research and control groups after being placed in two age categories using traditional lottery methods (writing names on paper). Considering the rarity of accessible patients, the sample size will be based on what is available and the willingness to participate in this project, within a radius of 100 kilometers from the research site

This study is conducted at the multidisciplinary center of Shariati Hospital in Tehran and its occupational therapy department, where patients receive supervised interventions for a duration of ten weeks.

nclusion criteria: Individuals aged ≥18 years with confirmed homozygous deletion of exon 7 in the SMN1 gene, clinical diagnosis of SMA type 3, and ability to walk independently for at least 25 meters. Exclusion criteria: History of surgery or fracture in the past six months, other chronic comorbidities, moderate to severe scoliosis, non-ambulatory SMA or SMA types other than type 3, and participation in other research studies.

The interventions include supervised progressive resistance training of the lower limbs in the experimental group, while the control group continues their usual daily activities.

Muscle strength; functional performance; serum creatine kinase; interleukin-6 (IL-6); interferon-gamma (IFN-γ); tumor necrosis factor-alpha (TNF-α); quality of life.

The sampling date in this RCT has been updated, as the collection process was conducted earlier than originally scheduled. This modification only concerns the timing of sampling and does not affect the methodology, inclusion/exclusion criteria, or other aspects of the protocol.

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.

The following documents will be shared after study completion and final approvals: the full study protocol, the statistical analysis plan, a de-identified version of the informed consent form, the final clinical study report, and the data dictionary. These materials will include methodological details, statistical procedures, variable definitions, and non-identifiable participant information. Access will be granted to qualified researchers upon formal request and in accordance with ethical and institutional guidelines.

Access to the listed documents—including the full study protocol, statistical analysis plan, de-identified informed consent form, final clinical study report, and data dictionary—will begin 6 months after publication of the main study results and remain available for 2 years to qualified researchers upon formal request

Access to the shared documents will be granted only to researchers and professionals affiliated with academic institutions, recognized research centers, or scientific organizations working in the fields of sports science, rehabilitation, or biomechanics. Applicants must demonstrate relevant research background and clearly state the intended purpose of data use.

The shared data and documents may only be used for research, educational, or technology development purposes in fields related to sports science, rehabilitation, and biomechanics. Secondary analyses, meta-analyses, or methodological reviews are permitted only if they are conducted with clearly defined scientific objectives, without any attempt to re-identify participants, and in full compliance with ethical and legal standards. Requests must include the applicant’s full affiliation, intended use, proposed type of analysis, and a formal commitment to data confidentiality. All requests will be reviewed and approved by the research team and relevant oversight bodies.

Interested applicants may submit a formal request via email to one of the study team members: • Shahram Khorshidi Email: shahram.khorshidi@ut.ac.ir • Khadije Sohrabi Email: khadije.sohrabi@ut.ac.ir Requests must include the applicant’s full affiliation, intended purpose of use, type of document requested, and a signed commitment to confidentiality and ethical compliance.

Upon receiving a formal request, the research team will review the application within two working weeks. The review will assess the applicant’s scientific qualifications, the stated purpose of use, the proposed type of analysis, and the commitment to confidentiality and ethical compliance. If approved, a data use agreement outlining the terms and limitations will be sent for signature. Once the signed agreement is received, the requested documents or data will be delivered within one working week via email or a secure data transfer platform.