Clinical trial NCT04484480: Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
Official title: Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Gait Disorders, Neurologic
Keywords: diabetes
gait
balance
falls
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 77
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetes mellitus type II (DMII) causes many complications, including retinopathy and peripheral neuropathy. These complications are well understood and believed to contribute to gait instability and increase the risk of falls. Poor balance control and increased falling risk have also been reported in people with diabetic peripheral neuropathy (DPN).

Patients with DPN are at an increased risk of falling due to the decreased proprioceptive feedbacks. Effective balance training should improve instabilities of postural control in patients with DPN. For this purpose, evaluations and balance training was designed.

The goal of our study was to establish values for proprioception, balance, muscle coordination and strength in patients with DMII, who underwent biofeedback balance training using the Biodex Balance System.

Detailed description: It is estimated that by the end of 2017 year, there will be 462 millions of patients suffering from diabetes mellitus type II (DMII), what is about 6% of world population (4,4% between 15 and 49 years of age, 15% between 50 and 69 years and 22% of patients older than 70 years). It is predicted that by the beginning of 2030, number of cases on 100000 people will grow from 6059 up to 7079. There are studies proving that cardiovascular complications related to the diabetes are responsible for 4 millions of deaths annually. The newest epidemiological data suggest that growing number of DMII cases is no longer a problem in developed countries but also affects developing ones. As potential risk factors, well proved in the literature authors reported alcoholism, nicotinism, high body-mass index (BMI) and positive family history. It is therefore anticipated that the prevalence of one of its common complications, a diabetic peripheral neuropathy (DPN), will increase as well. It is broadly recognized that a DPN leads to a decrement in distal lower limb sensory function; however, there is also a neuropathy-related decrease in distal motor function, even among those with relatively mild diabetic disease. It is well proven in the literature, that diabetes mellitus influences negatively function of peripheral nervous system by damaging sensory fibers. A high risk of falls has been reported in the diabetic population, with an overall incidence of 1.25 falls/person-year.It was proven that short-period strength and balance exercises do not improves diabetic patients quality of life However they have positive influence on the functional outcome of those people. Influence of DMII on motion system is not limited only to the peripheral nervous system. It also affects structures of cerebrum such as: cerebral cortex, cerebellum or basal nuclei. DMII affects motor and somatosensory cerebral atrophy what leads to changes in projection tracts associated with them. In cerebellum it affects on the vermis and parts of lobes responsible for receiving impulses from the spinal cord and controlling proximal parts of muscles, which are crucial for movement coordination during gait. Disorders caused by DMII in basal nuclei result in longer response time and slower gait velocity. Together with pharmacological and dietary interventions, exercise interventions including resistance training, represent the cornerstones of type 2 diabetes management. In addition to the beneficial effects of exercise interventions on glycemic control and on the cardiovascular risk factors associated with type 2 diabetes, physical exercise is an effective intervention to improve muscle strength, power output, cardiovascular function and functional capacity in elderly diabetic patients. In elderly diabetics with severe functional decline, multicomponent exercise programs composed of resistance, endurance, balance and gait retraining should be employed to increase functional capacity and quality of life and to avoid disability and falls. The aim of the study was to evaluate balance and motor coordination parameters in patients treated for type 2 diabetes who received biofeedback-equivalent training using the Biodex dynamometric platform.

Eligibility criteria: Inclusion Criteria:

* willingness to participate in the study
* age over 65
* diagnosed type 2 diabetes, subjected to pharmacological treatment (study group)
* no type 2 diabetes (control group)

Exclusion Criteria:

* unwillingness to participate in the study
* age below 65 years
* surgical intervention in the lower limbs or spine during the last 6 months
* symptoms of osteoarthritis or pain of another origin around the lower limbs or spine
* rheumatic diseases (eg. rheumatoid arthritis, ankylosing spondylitis)
* diagnosed neuromuscular disease
* strongly manifested imbalances due to impairment of central or peripheral nervous system
* neurological disorders with dizziness, nystagmus, dermatologic or profound (cerebrospinal syndrome, dizziness, multiple sclerosis, Parkinson's disease, etc.).

Primary outcomes:
measure: Fall risk test
timeFrame: 3-months after inclusion to the study
measure: General Stability Index
timeFrame: 3-months after inclusion to the study
measure: Frontal-Posterior Stability Index)
timeFrame: 3-months after inclusion to the study
measure: Medial-Lateral Stability Index
timeFrame: 3-months after inclusion to the study
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Othopedics and Rehabilitation, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Artur Stolarczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adamska O, Mamcarz A, Lapinski M, Radzimowski K, Stepinski P, Szymczak J, Swiercz M, Zarnovsky K, Maciag BM, Stolarczyk A. Continuous glycemia monitoring in perioperative period in patients undergoing total knee or hip arthroplasty: A protocol for a prospective observational study. Medicine (Baltimore). 2022 Oct 21;101(42):e31107. doi: 10.1097/MD.0000000000031193.
citation: Stolarczyk A, Jarzemski I, Maciag BM, Radzimowski K, Swiercz M, Stolarczyk M. Balance and motion coordination parameters can be improved in patients with type 2 diabetes with physical balance training: non-randomized controlled trial. BMC Endocr Disord. 2021 Jul 3;21(1):143. doi: 10.1186/s12902-021-00804-8.