Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects (BIONEDIAN)
Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Prague、捷克语、14200
- 招聘中
- Institute for Clinical and Experimental Medicine
-
接触：
- Eliška Vrátná, Mgr.
- 电话号码：+420774549214
- 邮箱：vratnae@gmail.com
-
接触：
- Vladimíra Fejfarová, MD, PhD
- 电话号码：+420603877381
- 邮箱：vlfe@medicon.cz
-
副研究员：
- Jitka Hazdrová, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：DF patient active
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
|
12 week lasting exercise intervention
|
|
有源比较器：DF patient control
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
|
12 week lasting exercise intervention
|
|
实验性的：Diabetic patient with mild neuropathy
Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy
|
12 week lasting exercise intervention
|
|
实验性的：Diabetic patient with severe neuropathy
Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy
|
12 week lasting exercise intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biomechanics- plantar pressures
大体时间：changes after 12 weeks, 24 weeks
|
plantar pressures will be evaluated by pedobarograph (in Newtons)
|
changes after 12 weeks, 24 weeks
|
|
Biomechanics- biomechanics of the ankle
大体时间：changes after 12 weeks, 24 weeks
|
biomechanics of the ankle will be assessed by goniometry in angles
|
changes after 12 weeks, 24 weeks
|
|
Biomechanics- changes of foot joint angles
大体时间：changes after 12 weeks, 24 weeks
|
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
大体时间：changes after 12 weeks, 24 weeks
|
The amount of physical activity will be assessed by IPAQ questioners
|
changes after 12 weeks, 24 weeks
|
|
Fitness - muscle strength
大体时间：changes after 12 weeks, 24 weeks
|
Muscle strength will be measured by dynamometry in Newtons
|
changes after 12 weeks, 24 weeks
|
|
Fitness - senior fitness
大体时间：changes after 12 weeks, 24 weeks
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ulceration/reulceration
大体时间：changes after 12 weeks, 24 weeks
|
detection of the incidence of ulceration/reulceration
|
changes after 12 weeks, 24 weeks
|
|
Psychosocial changes - quality of life
大体时间：changes after 12 weeks, 24 weeks
|
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
大体时间：changes after 12 weeks, 24 weeks
|
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
大体时间：changes after 12 weeks, 24 weeks
|
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
大体时间：changes after 12 weeks, 24 weeks
|
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
大体时间：changes after 12 weeks, 24 weeks
|
The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l)
|
changes after 12 weeks, 24 weeks
|
|
Metabolism - myokines
大体时间：changes after 12 weeks, 24 weeks
|
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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.