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

NCT ID: NCT04330053

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-04-10

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.

Conditions

Elderly; Accidental Falls; Prevention; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

Information - Education about falls and Exercise for Fall Prevention

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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.

Control

Information - Education about falls without Exercise for Fall Prevention

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

Experimental

• 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.

Intervention Type: OTHER

Control

• 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.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

LYTRAS DIMITRIOS

Dimitrios Lytras PT, Phd, Postdoc Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evaggelos Sykaras

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

Aristotle University of Thessaloniki

Thessaloniki, Central Makedonia, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 35606677 (View on PubMed)

Other Identifiers

44338/2020

Identifier Type: -

Identifier Source: org_study_id