Comparison of the effects of combined balance and strength training with and without blood flow restriction on balance, functional strength, pain, physical function, and quality of life in patients with knee osteoarthritis

The primary aim of this study is to examine the effects of two exercise interventions on balance, functional strength, pain, and quality of life in patients with knee osteoarthritis.

A randomized, single-blind, parallel-group controlled clinical trial conducted on 32 patients. Randomization was performed using the RAND function in Microsoft Excel.

This study is a randomized, parallel-group, single-blind clinical trial that will be conducted on 32 patients with knee osteoarthritis. The study will take place at the Orthopedic Clinics of Yazd University of Medical Sciences. The trial will be single-blind for participants; that is, participants will not be aware of the existence of the other group or the differences between the groups.

Inclusion criteria: Age over 50 years; Diagnosis of knee osteoarthritis (unilateral or bilateral) based on the American College of Rheumatology criteria; Presence of clinical symptoms such as pain and functional limitation for at least three months; Ability to provide informed consent and willingness to adhere to the study protocol. Exclusion criteria: History of knee surgery; History of any invasive procedure in the affected knee; Concurrent physiotherapy or strengthening exercise program for the affected knee; Any injury affecting lower limb function; Presence of neurological, cardiac, or vascular diseases, including blood coagulation disorders; History of venous thromboembolism; Conditions affecting balance.

Intervention group: Participants will perform a combination of balance and strengthening exercises with blood flow restriction. Control group: Participants will perform the same balance and strengthening exercises without blood flow restriction.

Static and dynamic balance, functional strength, pain, functional activities, quality of life.

Randomization Method: Block randomization (blocks of 4, pattern aabb) was used to ensure balanced group sizes. Unit of Randomization: Individual participants. Stratification: None. Random Sequence Generation: Blocks were listed in Excel and their order randomized using =RAND(). Allocation Concealment: Sequence was prepared and managed by the researcher (study author) in a password-protected Excel file; group assignment was revealed only after participant enrollment

In this study, only the participants were blinded to group allocation. Participants were not informed about which group they had been assigned to, and no information that could reveal the type of intervention they received was disclosed to them. Therefore, participants were unable to determine their assigned group, and participant-level blinding was maintained. It should be emphasized that all participants entered the study with informed consent and were fully aware that they were taking part in a research project. Thus, participant blinding was implemented solely to preserve the scientific integrity of the trial, and no withholding of information that would violate ethical principles occurred.

Title: De-identified Individual Participant Data (IPD) and Statistical Analysis Files Details: The shared files will include de-identified individual participant data related to primary and secondary outcome measures (e.g., balance tests, strength outcomes, functional questionnaires). No identifiable personal information will be shared. Only datasets directly related to the main outcomes of the clinical trial will be available.

The data will become available 6 months after publication of the study results and will remain available for 3 years after publication.

The data will be available to qualified researchers who submit a reasonable request and provide a methodologically sound proposal. Access will be granted after approval by the principal investigator.

Deidentified IPD will be shared only for scientific and non-commercial research purposes, including analyses related to musculoskeletal rehabilitation and osteoarthritis. All requests will be reviewed by the principal investigator to ensure scientific validity, ethical approval, and protection of participant confidentiality.

Data can be obtained directly from the principal investigator via email. Farzaneh Yazdani Sadra City Road, Shahid Doran Campus, Faculty of Rehabilitation Sciences 09177135942 yazdani_far@sums.ac.ir

Applicants must send a written request to the principal investigator describing the purpose of analysis. Requests will be reviewed for scientific merit, ethical compliance, and confidentiality. Data will be shared after signing a data-sharing agreement.