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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Prague、チェコ、14200
- 募集
- Institute for Clinical and Experimental Medicine
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コンタクト：
- Eliška Vrátná, Mgr.
- 電話番号：+420774549214
- メール：vratnae@gmail.com
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コンタクト：
- Vladimíra Fejfarová, MD, PhD
- 電話番号：+420603877381
- メール：vlfe@medicon.cz
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副調査官：
- Jitka Hazdrová, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：DF patient active
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
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12 week lasting exercise intervention
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アクティブコンパレータ：DF patient control
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
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12 week lasting exercise intervention
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実験的：Diabetic patient with mild neuropathy
Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy
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12 week lasting exercise intervention
|
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実験的：Diabetic patient with severe neuropathy
Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy
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12 week lasting exercise intervention
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biomechanics- plantar pressures
時間枠：changes after 12 weeks, 24 weeks
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plantar pressures will be evaluated by pedobarograph (in Newtons)
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changes after 12 weeks, 24 weeks
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Biomechanics- biomechanics of the ankle
時間枠：changes after 12 weeks, 24 weeks
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biomechanics of the ankle will be assessed by goniometry in angles
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changes after 12 weeks, 24 weeks
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Biomechanics- changes of foot joint angles
時間枠：changes after 12 weeks, 24 weeks
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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
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changes after 12 weeks, 24 weeks
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Fitness - physical activity
時間枠：changes after 12 weeks, 24 weeks
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The amount of physical activity will be assessed by IPAQ questioners
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changes after 12 weeks, 24 weeks
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Fitness - muscle strength
時間枠：changes after 12 weeks, 24 weeks
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Muscle strength will be measured by dynamometry in Newtons
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changes after 12 weeks, 24 weeks
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Fitness - senior fitness
時間枠：changes after 12 weeks, 24 weeks
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fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)
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changes after 12 weeks, 24 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ulceration/reulceration
時間枠：changes after 12 weeks, 24 weeks
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detection of the incidence of ulceration/reulceration
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changes after 12 weeks, 24 weeks
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Psychosocial changes - quality of life
時間枠：changes after 12 weeks, 24 weeks
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Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings
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changes after 12 weeks, 24 weeks
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Psychosocial changes - depression
時間枠：changes after 12 weeks, 24 weeks
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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
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changes after 12 weeks, 24 weeks
|
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Psychosocial changes - stress readaptation
時間枠：changes after 12 weeks, 24 weeks
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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
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changes after 12 weeks, 24 weeks
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Metabolism - glucose control
時間枠：changes after 12 weeks, 24 weeks
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Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l)
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changes after 12 weeks, 24 weeks
|
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Metabolism - lipid profile
時間枠：changes after 12 weeks, 24 weeks
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The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l)
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changes after 12 weeks, 24 weeks
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Metabolism - myokines
時間枠：changes after 12 weeks, 24 weeks
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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)
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changes after 12 weeks, 24 weeks
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 546417
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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