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IRCT20230701058629N1 IRCT 2025-03-26 Shahid Bahonar University of Kerman Investigating the Impact of Pickleball on Balance, Spatial-Temporal Gait Parameters, and Psychosocial Factors in Older Women The effect of 8 Weeks of Pickleball on Balance, Spatio-Temporal Parameters of Gait, and Psychosocial Factors in Older Women 2024-04-06 anticipated 40 Complete https://irct.ir/trial/80493 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the random allocation process for assigning participants to experimental and control groups was meticulously designed based on robust methodological principles. Initially, a balanced (1:1) random sequence was generated using **Randomiser.org** software, which employs cryptographic algorithms for random number generation. This sequence was structured in fixed blocks of 8 participants (block randomization), with each block containing 4 allocations to the experimental group and 4 to the control group in a completely random and variable arrangement (e.g., experimental-control-experimental-control-control-experimental-control-experimental). The block size remained concealed from researchers to prevent prediction of allocation sequences. Following eligibility confirmation and completion of initial registration, each participant was automatically assigned the next code in this block sequence without any human intervention. To maintain allocation concealment, the allocation system was designed so that neither research team members nor participants knew group assignments until final registration and allocation were complete. This was implemented through a secure, encrypted online platform that only revealed the random sequence after definitive participant registration. The generated random sequence was verified and certified by an independent statistician uninvolved in study execution. All steps of random sequence generation, allocation execution, and data recording were thoroughly documented for methodological auditability. This sophisticated approach offered several key advantages: (1) it precisely maintained group balance both during and at study completion; (2) the concealed, automated allocation mechanism prevented selection bias and researcher influence; and (3) it ensured equitable chances for all participants to be assigned to either group. Such rigorous randomization design effectively prevented selection bias and confounding factors, significantly enhancing the study's internal validity. Complete randomization documentation, including generated codes, allocation timestamps, and related information, has been archived for future reference and verification, Blinding description: For blinding the study, the evaluators also had no information about the factors considered by the researcher until the end of the study. For example, regarding the assessment of participants' walking using the motion analysis system, the evaluator was unaware of the analysis of factors such as speed, step length, and double support during testing and merely conducted the test. N/A Older adults. Intervention 1: Intervention Group: Participants in this group took part in a structured pickleball training program for eight weeks. The program included three sessions per week, with each session lasting 60 minutes. The training was conducted in a controlled environment using standard pickleball equipment, including paddles, balls, and a designated court. Each session consisted of three phases: 1. Warm-up (10 minutes): Stretching exercises and light activities to prepare the body. 2. Main Pickleball Training (40 minutes): Skill drills, court movement exercises, and guided gameplay to enhance balance and gait performance. 3. Cool-down (10 minutes): Stretching and relaxation exercises to reduce muscle fatigue. This program was designed to increase physical activity levels, improve balance, and enhance mobility in older women. The training was supervised and conducted by certified pickleball instructors and sports physiologists. Intervention 2: Control group: Participants in this group did not receive any specific pickleball training intervention. They continued with their usual daily activities, and no structured exercise program was assigned to them. However, to monitor and control physical activity levels, participants were assessed weekly using a physical activity questionnaire. Yes - There is a plan to make this available What will be shared: All data can be shared after individuals are de-identified. When: The data access period will begin immediately after the results are published. To whom: The data will be available to researchers, organizations, and departments related to the pickleball discipline for journals. Conditions: To assist in scientific research and advance executive goals with the approach of improving the health of the elderly Where to obtain: Shima Sheikh Bahaie sh18.shima@gmail.com How to obtain: Requests for data review will be responded to within one week. Comments:
public Shima Sheikh Bahaie
Shahid Bahonar University, Imam Khomeini Highway, Pajoohesh Square.
Kerman Iran (Islamic Republic of) 7616913439 +98 34 3325 7141 sh18.shima@gmail.com Shahid Bahonar University of Kerman scientific Shima Sheikh Bahaie
Shahid Bahonar University, Imam Khomeini Highway, Pajoohesh Square.
Kerman Iran (Islamic Republic of) 7616913439 +98 34 3325 7141 sh18.shima@gmail.com Shahid Bahonar University of Kerman Iran (Islamic Republic of) Age ≥60 years Ability to perform moderate physical activity No need for assistive devices for walking Ability to participate in training sessions Signed consent form 60 years 75 years Female Severe sensory-motor/visual impairments Pathological diseases History of lower limb musculoskeletal problems Incomplete screening questionnaires Recent use of painkillers Limb deformities, Recent history of falls Inability to perform the programs Participation in parallel studies Neurological/psychiatric disorders (epilepsy, Parkinson’s, MS) Rehabilitation Rehabilitation Intervention Group: Participants in this group took part in a structured pickleball training program for eight weeks. The program included three sessions per week, with each session lasting 60 minutes. The training was conducted in a controlled environment using standard pickleball equipment, including paddles, balls, and a designated court. Each session consisted of three phases: 1. Warm-up (10 minutes): Stretching exercises and light activities to prepare the body. 2. Main Pickleball Training (40 minutes): Skill drills, court movement exercises, and guided gameplay to enhance balance and gait performance. 3. Cool-down (10 minutes): Stretching and relaxation exercises to reduce muscle fatigue. This program was designed to increase physical activity levels, improve balance, and enhance mobility in older women. The training was supervised and conducted by certified pickleball instructors and sports physiologists. Control group: Participants in this group did not receive any specific pickleball training intervention. They continued with their usual daily activities, and no structured exercise program was assigned to them. However, to monitor and control physical activity levels, participants were assessed weekly using a physical activity questionnaire. Balance. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: Balance is assessed using the Mini-BESTest. Sُtride length. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: In the present study, stride length is assessed using a motion analysis system. Stride velocity. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: In the present study, stride velocity is assessed using a motion analysis system. Cadence. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: In the present study, cadence is assessed using a motion analysis system. Double support duration. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: In the present study, double support duration is assessed using a motion analysis system. Social capital. Timepoint: Before the start of the intervention and eight weeks after the start of the intervention. Method of measurement: Social capital is assessed using the Onyx and Bullen questionnaire. Shahid Bahonar University of Kerman Approved 2023-08-22 Ethics Committee of Sport Sciences Research Institute No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)