Effects of Different Type Exercise Trainings on Functionality in Older Fallers
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 18, 2020
January 1, 2020
7 months
July 12, 2019
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Balance Function Assessment-Sensory Organization Test
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
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
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
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
Study Arms (3)
vestibüler
ACTIVE COMPARATORvestibular exercise training
balance training
EXPERIMENTALvestibular exercise training+ balance training with computerized balance system
square-step
EXPERIMENTALvestibular exercise training+ square step exercise
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kırıkkale University
Kırıkkale, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 23467506BACKGROUNDShigematsu 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.
PMID: 18245764BACKGROUNDShigematsu 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.
PMID: 18283224BACKGROUNDFisseha 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.
PMID: 28349029BACKGROUNDMoreira 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.
PMID: 17684648BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşe ABİT KOCAMAN
Kırıkkale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
July 12, 2019
First Posted
July 29, 2019
Study Start
December 31, 2018
Primary Completion
August 1, 2019
Study Completion
January 1, 2020
Last Updated
January 18, 2020
Record last verified: 2020-01