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Completed

NCT Number: NCT04036383

Effects of Different Type Exercise Trainings on Functionality in Older Fallers

The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller

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Key information

Conditions

Fall Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale University

Kirikkale, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

vestibular exercise training

Other

The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises

Balance training with computerized balance system

Other

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.

square step exercises

Other

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.

Primary outcomes

  1. Balance Function Assessment-Sensory Organization Test

    Time frame: 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.

  2. Cognitive Function assessment

    Time frame: 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.

  3. Gait Function assessment

    Time frame: 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.

  4. Balance Function Assessment- Adaptation Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ayşe Abit Kocaman

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 29, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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