Clinical trial NCT04330053: Documentation of Fall Incidents and Application of a Fall Prevention Programme for Seniors in Northern Greece
Official title: A Record of Falls in Seniors in Central Macedonia and an Intervention for Injury Prevention Through Special Exercise Programs for Fall Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Accidental Falls
Prevention
Exercise
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Background: Falls in the elderly are a global health problem as they are associated with serious injuries and chronic disability. About 30% of seniors over 65 experience one or more falls each year. Any fall can lead to injury, a long period of immobilization, a decline in the functional level of the elderly, a negative psychological impact and often the elderly can even end up in death. The causes of the falls are multifactorial and are related both to the effects of aging on the human body and to environmental factors. 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 in contrast to 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 combination of balance exercises and strengthening of the core and lower limbs seems to have a positive effect on the elderly in avoiding 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 state body has not yet been possible.

Aim: The purpose of this study is to record the incidence of falls in older people, to inform and educate them on prevention and to study the effect of specialized therapeutic exercise in relation to the usual physiotherapeutic care in reducing the number of falls. Senior people will be selected from the Elderly Day Care Centers for this purpose.

Methods / Design: About 150 elderly people over 65 are expected to participate in this study. Participants will be recruited from 15 Day Care Centers, which will be divided into two groups (intervention and control). All participants will be informed and trained in fall prevention through lectures at the Day Care Center, as well as through the distribution of appropriate audiovisual material. Subsequently, the participants of the intervention group will follow a 6-month OTAGO group exercise program, where seniors will perform exercises three times a week. The control group participants will receive a leaftlet with general exercise (not falls prevention specific). The history of falls, fear of falling, balance and functional ability of participants will be assessed before, during and after the intervention, and will be re-examined 6 months after the intervention.

Expected results: The results of this research will give a first glimpse of the magnitude of the problem of falls in older people in Greece, as data will be collected on the number of episodes, the factors that cause them, the outcome of falls, etc. The effectiveness of targeted exercise programs and in particular of OTAGO in reducing the number of falls and improving the balance and functional capacity of older people will also be explored.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Changes in CONFbal - GREEK score questionnaire
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in Short Falls Efficacy Scale International (Short FES-I) score questionnaire
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in 4-Stage Balance Scale test
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in Timed Up and Go test
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in number of falls
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in the 30-Second Chair Stand Test
timeFrame: Pre-treatment, Month 6, 12
measure: Changes in Berg Balance scale Test
timeFrame: Pre-treatment, Month 6, 12
Secondary outcomes:
measure: Changes in adherence to exercise via Exercise Diary keeping
timeFrame: Month 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
state: Central Makedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Evaggelos Sykaras
role: STUDY_DIRECTOR
References:
citation: 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.