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Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects (BIONEDIAN)

3. februar 2020 opdateret af: Mgr. Eliška Vrátná

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tjekkiet
      • Prague, Tjekkiet, 14200
        • Rekruttering
        • Institute for Clinical and Experimental Medicine
        • Kontakt:
        • Kontakt:
          • Vladimíra Fejfarová, MD, PhD
          • Telefonnummer: +420603877381
          • E-mail: vlfe@medicon.cz
        • Underforsker:
          • Jitka Hazdrová, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DF patient active
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
Andet: Physical intervention by exercise
12 week lasting exercise intervention
Aktiv komparator: DF patient control
Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers
Andet: Physical intervention by exercise
12 week lasting exercise intervention
Eksperimentel: Diabetic patient with mild neuropathy
Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy
Andet: Physical intervention by exercise
12 week lasting exercise intervention
Eksperimentel: Diabetic patient with severe neuropathy
Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy
Andet: Physical intervention by exercise
12 week lasting exercise intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomechanics- plantar pressures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: changes after 12 weeks, 24 weeks
Muscle strength will be measured by dynamometry in Newtons
changes after 12 weeks, 24 weeks
Fitness - senior fitness
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ulceration/reulceration
Tidsramme: changes after 12 weeks, 24 weeks
detection of the incidence of ulceration/reulceration
changes after 12 weeks, 24 weeks
Psychosocial changes - quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mgr. Eliška Vrátná

Samarbejdspartnere

Vladimíra Fejfarová, MD, PhD
prof. Ing. Václav Bunc, CSc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2019

Primær færdiggørelse (Forventet)

30. marts 2020

Studieafslutning (Forventet)

1. januar 2021

Datoer for studieregistrering

Først indsendt

15. december 2019

Først indsendt, der opfyldte QC-kriterier

3. februar 2020

Først opslået (Faktiske)

6. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 546417

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

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