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IRCT20250513065709N1 IRCT 2025-08-03 Kerman University of Medical Sciences The effect of whole body electrical muscle stimulation on spinal diseases Exploring the Role of Whole Body Electrical Muscle Stimulation in Weight Loss and Functional Enhancement for Individuals with Degenerative Joint Diseases of the Spine and Limited Physical Activity and High Body Mass Index 2025-08-06 anticipated 108 Complete https://irct.ir/trial/83524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization process will be performed using random number generation software. In this regard, each eligible patient will be assigned a unique identification code to maintain confidentiality and facilitate unbiased randomization. Randomization will be performed using a random block design with variable size to ensure balance of group sizes throughout the study. Participants will be randomly assigned to one of the following three parallel groups: control group (CG), isometric exercise group (ISO) with isometric exercises and wearing a WB-EMS garment without electrical stimulation, and isometric exercise plus electromyostimulation (ISO + EMS) group with isometric exercises and wearing a WB-EMS garment with electrical stimulation, Blinding description: This study employs a single-blind design where outcome assessors and data collectors are blinded to group allocation, while participants acannot be blinded due to the nature of the intervention. Participants are aware of their group assignment as they can distinguish between receiving electrical stimulation (ISO + EMS group) versus wearing the WB-EMS suit without stimulation (ISO group) or no intervention (control group). However, outcome assessors who conduct anthropometric measurements, questionnaire administration, and functional tests (6MWT, Two-Stage Treadmill Test) are completely blinded to group allocation and will not have access to randomization records. Data collectors responsible for recording measurements and questionnaire responses are also blinded to treatment assignment. The statistical analyst will remain blinded to group allocation during data analysis until the final interpretation phase. 3 Neurodegenerative Spine Diseases. Intervention 1: Control group: Participants only receive standard care including education on ergonomic principles and spinal care, light stretching and strengthening exercise program appropriate to patient condition, nutritional counseling for weight management, and regular follow-up by the treatment team without any electrical muscle stimulation intervention. Intervention 2: Intervention group 1: Isometric Exercise Group (ISO): Participants wear WB-EMS suits without electrical stimulation and perform supervised isometric exercises twice weekly on non-consecutive days for 30 minutes per session over 8 weeks, including 20 minutes of main training with 6-second contraction and 4-second rest intervals, plus 5-minute warm-up and cool-down periods with stretching movements. Intervention 3: Intervention group 2: Isometric Exercise + Electromyostimulation Group (ISO + EMS): Participants wear WB-EMS suits with electrical stimulation and perform the same supervised isometric exercise protocol as the ISO group, with electrical stimulation intensity progressing from 60% of maximum tolerable stimulation (MT1) during weeks 1-4, to 70% MT1 during weeks 5-6, and 80% MT1 during weeks 7-8, using 85 Hz frequency and 350 microsecond pulse width. 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 There is no further information
public Reza Karimabadi
Shahid Gharani
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 5433 Rkarimabadi09@gmail.com Kerman University of Medical Sciences scientific Reza Karimabadi
Shahid Gharani
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 5433 Rkarimabadi09@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Degenerative spinal disease diagnosed clinically and according to radiologic findings Patients with limited mobility to perform activities according to the WIQ index (Score <45) Aged 50-79 years old Ability to understand and implement intervention instructions BMI equal to or greater than 30 kg/m2 Willingness to participate and signing an informed consent form 50 years 79 years Both Established neuromuscular disease Established psychiatric disorders Diagnosed balance disorders and vertigo History of spinal surgery in the past 6 months Severe or uncontrolled cardiovascular disease, including uncontrolled blood pressure (systolic blood pressure > 180 mmHg or diastolic > 110 mmHg) or uncontrolled diabetes (HbA1c > 8%). Pregnancy or breastfeeding. Use of anticoagulants. Presence of metal implants in the body (except dental implants). Presence of red flags of back pain in patients. Presence of advanced degenerative knee disease Failure to continue training within eight weeks and willingness to withdraw from the study (Dropping) Active rheumatic diseases (such as rheumatoid arthritis, lupus, ankylosing spondylitis) that are not under control G32.0 Subacute combined degeneration of spinal cord in diseases classified elsewhere N/A Rehabilitation Treatment - Devices Control group: Participants only receive standard care including education on ergonomic principles and spinal care, light stretching and strengthening exercise program appropriate to patient condition, nutritional counseling for weight management, and regular follow-up by the treatment team without any electrical muscle stimulation intervention. Intervention group 1: Isometric Exercise Group (ISO): Participants wear WB-EMS suits without electrical stimulation and perform supervised isometric exercises twice weekly on non-consecutive days for 30 minutes per session over 8 weeks, including 20 minutes of main training with 6-second contraction and 4-second rest intervals, plus 5-minute warm-up and cool-down periods with stretching movements. Intervention group 2: Isometric Exercise + Electromyostimulation Group (ISO + EMS): Participants wear WB-EMS suits with electrical stimulation and perform the same supervised isometric exercise protocol as the ISO group, with electrical stimulation intensity progressing from 60% of maximum tolerable stimulation (MT1) during weeks 1-4, to 70% MT1 during weeks 5-6, and 80% MT1 during weeks 7-8, using 85 Hz frequency and 350 microsecond pulse width. Walking Impairment Questionnaire (WIQ) Score. Timepoint: Baseline and 8 weeks. Method of measurement: Standardized Walking Impairment Questionnaire (WIQ) questionnaire. Low Back Pain Intensity. Timepoint: baseline and 8 weeks. Method of measurement: Numerical Rating Scale (NRS). Health-Related Quality of Life. Timepoint: baseline and 8 weeks. Method of measurement: Short Form-36 questionnaire (SF-36). 6-Minute Walk Test Distance. Timepoint: baseline and 8 weeks. Method of measurement: Measured as total distance walked in meters over 6 minutes on flat 30-meter course. Two-Stage Treadmill Test Duration. Timepoint: baseline and 8 weeks. Method of measurement: Measured as walking time in seconds during second stage at 3 km/h with 10% incline. Anthropometric Measures. Timepoint: baseline and 8 weeks. Method of measurement: BMI, waist Circumference, and hip Circumference will be measured by standardized meter and scale. Body Composition. Timepoint: baseline and 8 weeks. Method of measurement: segmental direct multi-frequency bioelectrical impedance analysis. Kerman University of Medical Sciences Approved 2025-05-11 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences Vice Chancellor for Research and Technology, Kerman University of Medical Sciences, Kerman, Jahad Street, Somayeh Crossroads, Kerman Kerman Kerman Iran (Islamic Republic of)