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IRCT20241004063260N3 IRCT 2025-12-08 Shiraz University of Medical Sciences Comparing two exercise methods to improve balance, strength, and reduce pain in people with knee osteoarthritis 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 2025-12-20 anticipated 32 Complete https://irct.ir/trial/87456 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Knee Osteoarthritis. Intervention 1: The intervention group performed a combined program of strength and balance exercises with blood flow restriction (BFR). The program consisted of 10 daily sessions, each lasting approximately 45 minutes. Exercise intensity and volume were individualized according to participants’ abilities, and progression was applied throughout the 10 sessions to ensure safety and maximize effectiveness. Intervention 2: The control group performed the same combined strength and balance exercises without BFR. The number of sessions, session duration, exercise intensity and volume, and progression were identical to the intervention group, ensuring that the only difference between the groups was the application of BFR.The program consisted of 10 daily sessions, each lasting approximately 45 minutes. Exercise intensity and volume were individualized according to participants’ abilities, and progression was applied throughout the 10 sessions to ensure safety and maximize effectiveness. Yes - There is a plan to make this available What will be shared: 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. When: The data will become available 6 months after publication of the study results and will remain available for 3 years after publication. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Farzaneh Yazdani
School of Rehabilitation Sciences, Shahid Doran Campus, Sadra Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 yazdani_far@sums.ac.ir Shiraz University of Medical Sciences scientific Farzaneh Yazdani
School of Rehabilitation Sciences, Shahid Doran Campus, Sadra Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 yazdani_far@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age above 50 years Diagnosis of knee osteoarthritis (unilateral or bilateral) according to the American College of Rheumatology (ACR) criteria. In patients with bilateral knee osteoarthritis, the knee with the worse Kellgren-Lawrence grade will be considered the affected knee. Radiographic evidence of knee osteoarthritis with Kellgren-Lawrence grade II or III. Presence of clinical symptoms such as pain and functional limitation for at least three months. Ability to provide informed consent and willingness to comply with the study protocol 50 years no limit Both History of any invasive procedure on the affected knee, including arthroscopy or intra-articular injection within the past 12 months. History of physiotherapy or strength training program for the affected knee concurrently with participation in the research study. Presence of injuries affecting lower limb function (except knee osteoarthritis). Presence of neurological, cardiac, or vascular diseases, including blood coagulation disorders. Other acute or chronic conditions that may affect physical or cognitive function. History of venous thromboembolism. Presence of diseases affecting balance, including inner ear disorders or plantar sensory impairments. M17.1 Unilateral primary osteoarthritis of knee Rehabilitation Rehabilitation The intervention group performed a combined program of strength and balance exercises with blood flow restriction (BFR). The program consisted of 10 daily sessions, each lasting approximately 45 minutes. Exercise intensity and volume were individualized according to participants’ abilities, and progression was applied throughout the 10 sessions to ensure safety and maximize effectiveness. The control group performed the same combined strength and balance exercises without BFR. The number of sessions, session duration, exercise intensity and volume, and progression were identical to the intervention group, ensuring that the only difference between the groups was the application of BFR.The program consisted of 10 daily sessions, each lasting approximately 45 minutes. Exercise intensity and volume were individualized according to participants’ abilities, and progression was applied throughout the 10 sessions to ensure safety and maximize effectiveness. Static Balance. Timepoint: Before, immediately after, and 4 weeks post-intervention. Method of measurement: Single Leg Stance Test. Dynamic Balance. Timepoint: Before, immediately after, and 4 weeks post-intervention. Method of measurement: Timed Up and Go Test. Functional Strength. Timepoint: before, immediately after, and 4 weeks post-intervention. Method of measurement: 30 Second Chair Stand Test. Pain. Timepoint: Before, immediately after, and 4 weeks post-intervention. Method of measurement: Numeric Rating Scale. Physical Function. Timepoint: Before, immediately after, and 4 weeks post-intervention. Method of measurement: WOMAC Questionnaire. Quality of life. Timepoint: Before, immediately after, and 4 weeks post-intervention. Method of measurement: KOOS Questionnaire. Shiraz University of Medical Sciences Approved 2025-10-01 Ethics Committee of Shiraz University of Medical Sciences Ethics committee, Research and Technology Vice-Chancellor, 7th floor, central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)