The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with different degrees of neuropathy. During this project, investigators will examine the possible impact of 12-week lasting intervention program on the distribution of plantar pressures, joint mobility and muscle strength of lower limbs. The incidence of ulcerations / reulcerations and changes of psychosocial characteristics will be evaluated during the study period. Approximately 60 patients with Type 2 diabetes mellitus will be included into the study. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot. The outcomes of this project will try to objectively verify in the randomized controlled trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
12 week lasting exercise intervention
Institute for Clinical and Experimental Medicine
Prague, Czechia
RECRUITINGBiomechanics- plantar pressures
plantar pressures will be evaluated by pedobarograph (in Newtons)
Time frame: changes after 12 weeks, 24 weeks
Biomechanics- biomechanics of the ankle
biomechanics of the ankle will be assessed by goniometry in angles
Time frame: changes after 12 weeks, 24 weeks
Biomechanics- changes of foot joint angles
changes of foot joint agles will be evaluated by measurement of X-Rays bones angles - calcaneal pitch, talar-1st metatarsal angle and lateral Talocalcaneal angle
Time frame: changes after 12 weeks, 24 weeks
Fitness - physical activity
The amount of physical activity will be assessed by IPAQ questioners
Time frame: changes after 12 weeks, 24 weeks
Fitness - muscle strength
Muscle strength will be measured by dynamometry in Newtons
Time frame: changes after 12 weeks, 24 weeks
Fitness - senior fitness
fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)
Time frame: changes after 12 weeks, 24 weeks
ulceration/reulceration
detection of the incidence of ulceration/reulceration
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - quality of life
Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - depression
Depression status will be asessed by Geriatric Depression Scale (GDS) scale - minimum 0, maximum 30 points (higher then 9 points- mild form of depression, higher then 20 - severe depression
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - stress readaptation
Adaptation to stress will be detected by Stress Readaption Scale (0-400 points) - points higher then 150 - higher risk of worse stress readaptation and therefore higher risk of somatisation
Time frame: changes after 12 weeks, 24 weeks
Metabolism - glucose control
Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l)
Time frame: changes after 12 weeks, 24 weeks
Metabolism - lipid profile
The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l)
Time frame: changes after 12 weeks, 24 weeks
Metabolism - myokines
Patients will be checked for changes in selected cytokines nad myokines (IL-4,6,7,8,15 in pg/ml, myostatin in pg/ml, irisin in ng/ml, FGF-21 in pg/ml)
Time frame: changes after 12 weeks, 24 weeks
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