- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04036383
Effects of Different Type Exercise Trainings on Functionality in Older Fallers
14. januar 2020 opdateret af: Ayşe Abit Kocaman
The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Individuals participating in the study will be blinded and 30 elderly individuals will be included.
Sociodemographic information of individuals, Mini Mental State Test, Fall Efficacy Scale, Dynamic Gait Index, Montreal Cognitive Assessment Scale, Daily Life Activities Scale for Vestibular Disorders, World Health Organization Quality of Life Scale-Elderly Module test results will be recorded.
Hip flexors and abductors, m.quadriceps femoris and m.tibialis anterior muscle strength will be measured by manual muscle dynamometer.
In balance assessments; sensory organization test and adaptation test of computerized dynamic posturography will be recorded.
Individuals will be divided into 3 groups by blocking and stratification randomization method.
All individuals in the group will perform vestibular exercise training twice a day for 8 weeks as a home exercise program.
In the first group, vestibular exercise training will be used as a home program, in the second group, individual rehabilitation program will be applied to the computerized balance system and in the third group, square step exercises will be applied.
Exercise training will be held 3 times a week for 8 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kırıkkale, Kalkun
- Kırıkkale University
-
-
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
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 65 years and older individuals,
- Mini Mental State Examination Test score above 24,
- At least two falls in the last year
- Independent individuals in mobilization without walking aid
Exclusion Criteria:
- Cardiac diseases
- Pulmonary embolism and deep vein thrombosis in the last three months,
- A history of cerebral aneurysm or intracranial hemorrhage,
- Acute retinal hemorrhage or previous ophthalmic surgery,
- Active infection,
- Multiple organ failure,
- Terminal disease status,
- A history of fractures in the lower and upper extremities within the last three months,
- Severe hearing and vision loss,
- Patients with Alzheimer's disease, Parkinson's disease, dementia
- Patients diagnosed with Benign Paroxysmal Positional Vertigo,
- Those who have received exercise training in the last 6 months,
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: vestibüler
vestibular exercise training
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
|
Eksperimentel: balance training
vestibular exercise training+ balance training with computerized balance system
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
|
Eksperimentel: square-step
vestibular exercise training+ square step exercise
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Balance Function Assessment-Sensory Organization Test
Tidsramme: 5 minutes
|
Sensory Organization Test (SOT): This is a six-part test that objectively identifies abnormalities in somatosensory, visual, and vestibular systems that provide postural control. The result is a ratio between 0-100 and 100 means perfect stability. |
5 minutes
|
|
Cognitive Function assessment
Tidsramme: 10 minutes
|
Cognitive function will be assessed with "Montreal Cognitive Assessment Scale(MoCA)"The MoCA is a screening instrument that evaluates cognitive domains on a single page and scores range from 0 to 30."0" points indicate poor cognitive functions, "30" points indicate good cognitive functions.
Increase in scores indicates better cognitive functions.
|
10 minutes
|
|
Gait Function assessment
Tidsramme: 15 minutes
|
Dynamic Gait Index will be used to evaluate the adaptations during the patient's gait.
It evaluates activities such as slow walking, fast walking, walking with head movements, turning, stepping up, jumping obstacles, 0 points are weak and 3 points are successful.
Low scores from the scale are indicative of disorders that may cause falls.A total of 8 parameters are evaluated over 24 points.
|
15 minutes
|
|
Balance Function Assessment- Adaptation Test
Tidsramme: 5 minutes
|
Adaptation Test (ADT):This test evaluates the patient's response to sudden changes and irregularities in the ground and the ability to reduce oscillations.
The oscillation energy score is obtained by measuring the force applied to the force platform for recovery.
Scores between 0 and 200.Since the maximum score given by the device is 200, the score of that test is considered as 200 in case of a fall.
The oscillation energy score is close to 0, indicating better postural adaptation.
|
5 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.
- Shigematsu R, Okura T, Nakagaichi M, Tanaka K, Sakai T, Kitazumi S, Rantanen T. Square-stepping exercise and fall risk factors in older adults: a single-blind, randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):76-82. doi: 10.1093/gerona/63.1.76.
- Shigematsu R, Okura T, Sakai T, Rantanen T. Square-stepping exercise versus strength and balance training for fall risk factors. Aging Clin Exp Res. 2008 Feb;20(1):19-24. doi: 10.1007/BF03324743.
- Fisseha B, Janakiraman B, Yitayeh A, Ravichandran H. Effect of square stepping exercise for older adults to prevent fall and injury related to fall: systematic review and meta-analysis of current evidences. J Exerc Rehabil. 2017 Feb 28;13(1):23-29. doi: 10.12965/jer.1734924.462. eCollection 2017 Feb.
- Moreira Bittar RS, Simoceli L, Bovino Pedalini ME, Bottino MA. The treatment of diseases related to balance disorders in the elderly and the effectiveness of vestibular rehabilitation. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):295-8. doi: 10.1016/s1808-8694(15)30071-9.
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)
31. december 2018
Primær færdiggørelse (Faktiske)
1. august 2019
Studieafslutning (Faktiske)
1. januar 2020
Datoer for studieregistrering
Først indsendt
12. juli 2019
Først indsendt, der opfyldte QC-kriterier
26. juli 2019
Først opslået (Faktiske)
29. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- FALL AND SQUARE STEP EXERCİSE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Efterårspatienter
-
Columbia AsiaAfsluttetPatient Compliance | Læge-patient forholdIndien
-
University of AarhusUkendtPatientengagement | Patient Empowerment | Patient Compliance
-
Peking Union Medical College HospitalAfsluttetPatient efter hjerteklapkirurgi | Patient med langvarig mekanisk ventilationKina
-
University of British ColumbiaAfsluttetMeddelelse | Tilfredshed | Læge-patient forhold | Sygeplejerske-patient relationerCanada
-
University of California, San DiegoPatient-Centered Outcomes Research Institute; University of Massachusetts... og andre samarbejdspartnereAfsluttetPatientengagement | Læge-patient forhold | Lægens rolle | Patient aktiveringForenede Stater
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityAfsluttet
-
University of Dublin, Trinity CollegeDublin Dental University HospitalRekrutteringOverholdelse, patientIrland
-
Centre Hospitalier le MansRekruttering
-
Fondazione Policlinico Universitario Agostino Gemelli...AfsluttetHjertekirurgisk patientItalien
-
Gustave Roussy, Cancer Campus, Grand ParisAfsluttet
Kliniske forsøg med vestibular exercise training
-
Marketa BonaventurovaAktiv, ikke rekrutterendeSund og rask | Vestibulær Schwannoma | Unilateralt Vestibulært UnderskudTjekkiet
-
Texas Scottish Rite Hospital for ChildrenIkke rekrutterer endnuHjernerystelse | Sportsskader hos børnForenede Stater
-
CochlearEuropean Innovation CouncilRekrutteringNormal hørelse | Vestibulær abnormitet | Balanceunderskud | Vestibulopati | Moderat til alvorligt høretabSpanien, Belgien
-
Vivonics, Inc.University of MichiganRekrutteringMild traumatisk hjerneskade, hjernerystelseForenede Stater
-
Hacettepe UniversityRekruttering
-
Aalto UniversityHelsinki University Central Hospital; Business FinlandIkke rekrutterer endnuVestibulær Schwannoma | Vestibulær lidelse | Vestibulær neuritisFinland
-
Cairo UniversityIkke rekrutterer endnu
-
Al-Ahliyya Amman UniversityIkke rekrutterer endnuUdholdenhedstid under stirring
-
Ain Shams UniversityFayoum UniversityAktiv, ikke rekrutterendeTandudtrækning | Øjeblikkeligt tandimplantat | Klasse II udsugningsstik | Estetisk zone implantologiEgypten
-
Ege UniversityTHE SCİENTİFİC AND TECHNOLOGİCAL RESEARCH COUNCİL OF TURKEY (TUBITAK)AfsluttetVestibulær migræneTyrkiet (Türkiye)