Effects of Different Type Exercise Trainings on Functionality in Older Fallers
14. januar 2020 oppdatert av: Ayşe Abit Kocaman
The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Kırıkkale, Tyrkia
- Kırıkkale University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. desember 2018
Primær fullføring (Faktiske)
1. august 2019
Studiet fullført (Faktiske)
1. januar 2020
Datoer for studieregistrering
Først innsendt
12. juli 2019
Først innsendt som oppfylte QC-kriteriene
26. juli 2019
Først lagt ut (Faktiske)
29. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FALL AND SQUARE STEP EXERCİSE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .