Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus

Conditions
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Prevention of Diabetic Foot

Intervention / Treatment
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* Other: Physical intervention by exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results) diabetic foot with healed diabetic foot ulcers, inactive Charcot foot Exclusion Criteria: impossibility to exercise amaurosis non-compliance critical limb ischemia active ulcer, surgical wound active Charcot foot active carcinoma recent stroke (last 8 weeks) recent myocardial infarction (last 8 weeks) recent PTA, PCI, bypass (last 8 weeks) myopathy rheumatoid arthritis cox-, gonartrosis of 3rd -4th grade.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 patients with Type 2 diabetes mellitus. 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DF patient active<br>Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers | Other: Physical intervention by exercise<br>* 12 week lasting exercise intervention<br>|
| Active Comparator: DF patient control<br>Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers | Other: Physical intervention by exercise<br>* 12 week lasting exercise intervention<br>|
| Experimental: Diabetic patient with mild neuropathy<br>Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy | Other: Physical intervention by exercise<br>* 12 week lasting exercise intervention<br>|
| Experimental: Diabetic patient with severe neuropathy<br>Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy | Other: Physical intervention by exercise<br>* 12 week lasting exercise intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanics- plantar pressures | plantar pressures will be evaluated by pedobarograph (in Newtons) | changes after 12 weeks, 24 weeks | 
| Biomechanics- biomechanics of the ankle | biomechanics of the ankle will be assessed by goniometry in angles | 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 | changes after 12 weeks, 24 weeks | 
| Fitness - physical activity | The amount of physical activity will be assessed by IPAQ questioners | changes after 12 weeks, 24 weeks | 
| Fitness - muscle strength | Muscle strength will be measured by dynamometry in Newtons | 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) | changes after 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulceration/reulceration | detection of the incidence of ulceration/reulceration | 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 | 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 | 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 | 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) | changes after 12 weeks, 24 weeks | 
| Metabolism - lipid profile | The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l) | 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) | changes after 12 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, biomechanics, quality of life, prevention