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

Determining the effect of electrical muscle stimulation on weight loss and improvement of functional disability in patients with degenerative spinal disease with high body mass index and limited physical activity

Single-blinded Randomized Controlled Trial

This study will be conducted at Shahid Bahonar Hospital in Kerman as a single-blind, randomized controlled trial.

Inclusion criteria (summary): • Degenerative spinal condition diagnosed clinically and according to radiologic findings • Patients with limited mobility to perform activities according to the WIQ index (Score < 45) Exclusion criteria (summary): • Established neuromuscular disease. • History of spinal surgery in the past 6 months. • Severe or uncontrolled cardiovascular disease • Presence of metal implants in the body (except dental implants). • Presence of advanced degenerative knee disease

Participants will be randomly assigned to one of three parallel groups: control group (CG), isometric exercise group (ISO) with isometric exercises and wearing WB-EMS clothing without electrical stimulation, and isometric exercise plus electromyostimulation (ISO + EMS) group with isometric exercises and wearing WB-EMS clothing with electrical stimulation.

-Anthropometric Measures - Walking Impairment Questionnaire (WIQ) - Low back pain intensity measured by the Numerical Rating Scale (NRS) - Health-related quality of life assessment using the Short Form-36 (SF-36) questionnaire - Functional capacity and exercise tolerance evaluated through the 6-Minute Walk Test (6MWT) - Cardiovascular endurance assessed via the Two-Stage Treadmill Test

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.

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.