This interdisciplinary project (Technology Readiness Level 9, TRL 9) aims to translate and clinically validate the effectiveness of an innovative wearable electrical stimulator technology for improving balance, quality of life, and skin perfusion in patients with diabetes and chronic kidney failure. Around the world, more than 347 million people suffer from diabetes, with 90% of them having Type 2 diabetes. The most common factors contributing towards diabetes include excessive body weight and poor physical activity. Among other countries around the world, Qatar has also been a victim to the COVID-19 pandemic with a prevalence of nearly 23%, thereby increasing the associated healthcare cost. One of the common predictors of metabolic syndrome in Qatar was found to be increased body mass index, which is usually associated with dietary and sedentary behavior. Management of diabetes is therefore of utmost importance in Qatar in order to reduce the negative impact of complications related to diabetes. One big challenge is encouraging patients with diabetes to be active in particular those with poor balance control, which is unfortunately prevalent among patients with diabetes. Poor postural control is often the primary comorbidity that limits their ability to be engaged in daily physical activities and seems to have a significant impact on quality of life.
Exercise is probably the best evidence-based intervention to enhance balance. But unfortunately exercising among patients with diabetes is limited in particular among older patients, who are also suffering from diabetic peripheral neuropathy, which impacts 60 to 70 percent of older patients with diabetes. In particular, the lack of mobility and poor adherence to exercise are major concerns among patients with diabetes and end-stage renal disease (ESRD) that require dialysis. Among patients with diabetes, 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Patients, who are undergoing hemodialysis (HD) are known to have a decreased ability to perform physical exercise, with exercise capacity reported to be at 60-70% of age-expected level leading to impaired physical functioning, muscle wasting, frailty at an earlier age, and increased risk of falling. Moreover, a 4-hour conventional HD session immobilizes the patient, contributing directly to sedentary behavior that can further worsen their functional motor abilities. Unfortunately, exercise programs are not widely used in HD clinical practice. Several studies have demonstrated that exercise training can improve balance and gait, thereby reducing fall risk in older adults including HD patients. Recent evidence also suggests that exercise can increase joint mobility and peripheral blood flow, which reduces the risk of foot complications in patients receiving HD. However, uptake of exercise programs for HD patients has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Conventional fall prevention exercise strategies, including physiotherapy, strength exercises, and tai chi, are not well suited for HD patients because even moderate conventional exercise regimes can easily overtax them. The selection of exercise modalities and intensities must also avoid excessive plantar loading, which can increase the risk of foot ulceration. Furthermore, because HD treatment often leaves patients feeling fatigued and thus, reluctant to engage in physical activity, any balance training intervention outside of HD treatment may not be practical. Thus, an alternative intervention, which may effectively address poor balance, may assist in encouraging HD individuals to become more active. Another key complication associated with diabetes is lower extremities problems. Recent studies suggest that the most common cause of hospitalization of diabetes population is foot-related complications including ulcers. Furthermore, in HD patients, the risk of foot complications and amputation is even more common, expensive, and devastating. Interestingly, even though the incidence of foot ulcers in patients with dialysis has been reported to be the same as with patients with a history of foot ulcers; dialysis patients have a significantly higher rate of foot amputation. Foot-related hospital admission rate is higher in HD patients; additionally, the prevalence of foot complications among HD patients with diabetes is 250% more than patients with diabetes without end-stage renal disease. With 10 times, higher incidence of lower extremity amputation; after amputation and post-operative mortality is also 3.5 times higher in HD patients compared to patients with diabetes not requiring dialysis.
To address the above gaps, the investigators propose translating an innovative wearable electrical stimulation intervention, practical for therapy during HD sessions. The long-term goal is to provide a convenient, low-cost therapeutic device and treatment protocol for patients with diabetes who are undergoing the hemodialysis process. Eventually, the investigators plan for this to be an approach that can be used during HD sessions as a routine intervention program to enhance mobility and reduce the risk of diabetic foot problems and peripheral arterial diseases (PAD). This study will be a double-blind randomized clinical trial design consisting of two groups of fifty (n=50) HD patients with diabetes and some level of postural instability. The study consisted of a 12 weeks treatment phase (three interventions per week) and two weeks of retention. In addition, all subjects will be followed up for 12 months post-intervention to document any incidents of falls, diabetic foot ulcers, limb amputation, and diabetes-related complications. Subjects will be provided plantar electrical stimulation treatment for a duration of an hour while receiving HD treatment, 3 times per week. The plantar electrical stimulation will be delivered using an innovative wearable technology based on FDA cleared wearable electrical stimulation system, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for the management of chronic pain. However, the system was modified by to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off for 60 minutes. The device is activated using a single button without the need for any electrical stimulation adjustment making it easier for the purpose of home therapy under unsupervised conditions and suitable for busy HD clinics. The proposed dosage regimen was used in a preliminary studies by the investigators and no related adverse events were reported while a significant improvement in skin perfusion and balance was observed. Sufficient disposable electrodes will be provided to participants for regular replacement.
