Documentation of Fall Incidents and Application of a Fall Prevention Programme for Seniors in Northern Greece

NCT04330053 | Completed

• 1 other identifier: 44338/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece, unlike other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a government agency in Greece such as the Elderly Day Care Centers (EDCC) has not yet been possible.

Conditions

Elderly; Accidental Falls; Prevention; Exercise

Outcome Measures

Primary Outcomes (7)

• Changes in CONFbal - GREEK score questionnaire

  The CONFbal questionnaire is a tool that assesses the self-esteem of an elderly person associated with the risk of falling. It consists of a 10-item scale, which are summed to give an index of balance confidence. The score ranges from 10 to 30. A higher score indicates lower balance confidence. Τhe questionnaire demonstrates excellent internal consistency and excellent test-retest reliability. The Greek version of the questionnaire CONFbal - GREEK (Billis, et al., 2011) will be used in this study.

  Pre-treatment, Month 6, 12

• Changes in Short Falls Efficacy Scale International (Short FES-I) score questionnaire

  Short FES-I is a measure of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice. It is the short version of the Falls Efficacy Scale International (FES-I), comprised of seven questions and is more applicable in clinical practice. The score ranges from 7 to 28. A higher score indicates greater fear of falling. The Greek version of the questioner (Billis, et al., 2011) will be used in this study

  Pre-treatment, Month 6, 12

• Changes in 4-Stage Balance Scale test

  The 4-Stage Balance Test is an assessment of static balance in four different and increasingly challenging positions - feet together, instep of foot advanced to toe of other foot, foot in front of other foot (tandem), and single leg stance (Lajoie \& Gallagher, 2004). The participant must stand in each position for ten seconds, while the examiner tracks time using a stopwatch. Each of the first three positions is evaluated with the eyes open and closed, while the single leg stance is evaluated only with the eyes open, so each participant is evaluated in a total of seven tests. Each test is scored from four to zero (representing "able to stand for 10 seconds safely" and "needs help to keep from falling" respectively). The final score results from the sum of all seven tests and ranges from zero to 28. A higher score indicates greater static balance ability of the participant. The test has good validity (Marques et al., 2017).

  Pre-treatment, Month 6, 12

• Changes in Timed Up and Go test

  It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant.

  Pre-treatment, Month 6, 12

• Changes in number of falls

  Changes in number of falls will be evaluated through a Falls diary which will be completed each month by the elderly

  Pre-treatment, Month 6, 12

• Changes in the 30-Second Chair Stand Test

  The 30-Second Chair Stand Test is a test for assessing leg strength and endurance in elderly adults. It is part of the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit, which was created by the Centers for Disease Control and Prevention as a screening tool for seniors belonging in the high fall risk group (Stevens, 2013). The test measures the number of times an elderly person can get up from a chair with their arms crossed in front of their trunk (on the opposite shoulder crossed at the wrists) in 30sec. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults. The test has been characterized by excellent test-retest reliability in a total number of participants: r = 0.89 (95% Confidence interval 0.79-0.93) (Rikli \& Jones, 1999).

  Pre-treatment, Month 6, 12

• Changes in Berg Balance scale Test

  The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015).

  Pre-treatment, Month 6, 12

Secondary Outcomes (1)

• Changes in adherence to exercise via Exercise Diary keeping

  Month 7, 8, 9, 10, 11, 12

Study Arms (2)

Experimental

EXPERIMENTAL

Information - Education about falls and Exercise for Fall Prevention

Other: Experimental

Control

ACTIVE COMPARATOR

Information - Education about falls without Exercise for Fall Prevention

Other: Control

Interventions

Experimental OTHER

* Training will address issues such as: environmental security, identifying hazards that can lead to a fall, psychological support, getting up from a fall, standing techniques and calling for help. * The exercise program will last for six months and will be based on the OTAGO exercise program, which includes five exercise groups: general warm-up, muscle strengthening exercises, balance exercises, range of motion and stretching exercises. The program will be performed individually or in groups of two people at most and will be conducted once a week in one of the 5 outpatient clinics under the supervision of a specialized OTAGO trainer, while seniors should repeat the exercises twice a week alone at home and also walk twice a week for at least half an hour.

Experimental

Control OTHER

* Information / Education about falls The participants in this group will receive the same information - education as the participants of the 1st group. * They will be given a leaflet with general gentle exercises (not fall prevention specific) for the home.

Control

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People aged 65 - 80
• Ambulatory people who walk independently or with some walking assistance device
• People with a history of at least one fall in the last 12 months
• People with Timed Up and Go test score minor than 15sec

You may not qualify if:

• People who were diagnosed with neurodegenerative disease (e.g. Parkinson's disease)
• People who recently had a stroke
• People with decreased ability to communicate (senile dementia etc.)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Central Makedonia, 57001, Greece

Location

Related Publications (1)

• Lytras D, Sykaras E, Iakovidis P, Komisopoulos C, Chasapis G, Mouratidou C. Effects of a modified Otago exercise program delivered through outpatient physical therapy to community-dwelling older adult fallers in Greece during the COVID-19 pandemic: a controlled, randomized, multicenter trial. Eur Geriatr Med. 2022 Aug;13(4):893-906. doi: 10.1007/s41999-022-00656-y. Epub 2022 May 24.

  PMID: 35606677 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Evaggelos Sykaras

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor-blind randomized control trial. A masked assessor conducted the measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dimitrios Lytras PT, Phd, Postdoc Research Fellow

Model Details: An assessor-blind randomized control trial with a duration of six months and a 6-month follow up will be performed in 150 seniors with a history of a previous fall. The participants will be allocated into two groups of 75 persons each (one intervention group and one control group). The first group will receive consulting about home modification for home safety related to fall prevention and training on how to avoid a fall and how to act if a fall occurs. Additionally, the first group participants will follow a fall prevention exercise program based on the OTAGO exercise program. The second group (control group) will receive only the consulting and training part excluding the fall prevention exercise program.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: December 1, 2019
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)