A strength and balance exercise program combined with vestibular training could improve postural stability and reduce fall risk in elderly population - a follow-up study
This study aims to explore whether a strength and balance exercise program combined with vestibular training could improve postural stability and reduce fall risk in the elderly population.
Design
A follow-up clinical trial, not randomized with a blinded outcome assessment of 30 elderly subjects, with a history of falls, regarding a decrease in fall risks.
Settings and conduct
This study consisted of 2 months of a balance rehabilitation program, with 2 sessions/ week of balance rehabilitation on the Framiral Multitest Equilibre dynamic platform, completed by 3 sessions/week of the Otago exercise program, performed at home.
Participants/Inclusion and exclusion criteria
The inclusion criteria: (a) age above 70 years, (b) subjects with a history of falling in the last year; (c) no medical or vestibular rehabilitation treatment in the previous 6 months, (d) subjects who completed the rehabilitation program.
The exclusion criteria: subjects who: (a) did not want to participate in the study, (b) had conditions requiring medication potentially generating the dizziness; (c) presented limitations for the tests, and (d) those who did not attend one of the scheduled assessment sessions.
Intervention groups
The intervention group consists of 30 subjects physically inactive elderly persons in the past 6 months. They will receive 2 months of a balance rehabilitation program, with 2 sessions/ week of balance rehabilitation on the Framiral Multitest Equilibre dynamic platform, completed by 3 sessions/week of the Otago exercise program, performed at home.
Main outcome variables
Index of postural instability (IPI)
Balance Outcome Measure for Elder Rehabilitation (BOOMER)
The Falls Efficacy Scale International (FES-I)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240722062512N1
Registration date:2024-07-27, 1403/05/06
Registration timing:prospective
Last update:2024-07-27, 1403/05/06
Update count:0
Registration date
2024-07-27, 1403/05/06
Registrant information
Name
Doriana Ioana Ciobanu
Name of organization / entity
The University of Oradea
Country
Romania
Phone
+40 259 408 419
Email address
dciobanu@uoradea.ro
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A strength and balance exercise program combined with vestibular training could improve postural stability and reduce fall risk in elderly population - a follow-up study
Public title
Rehabilitation in elderly fall risk assessment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 65 - 85 years;
Subjects with a history of 1-3 fallings in the last year;
No medical or vestibular rehabilitation treatment in the previous 6 month;
Subjects who completed the rehabilitation program;
Subjects who completed the three assessments;
Exclusion criteria:
Subjects who did not meet the age requirements
Subejcts who did not want to participate in the study
Subjects with conditions requiring medication potentially generating the dizziness
Subjects who presented limitations for the tests
Subjects who did not attend one of the scheduled assessment sessions
Age
From 65 years old to 85 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
The subjects will be assessed three times, baseline, final and follow-up
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person designated for assessment will not be involved in the rehabilitation process nor know who will be enrolled in the study.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Scientific Research Conduct and Ethics, University of Oradea
Street address
str. Universitatii, nr.1
City
Oradea
Postal code
410087
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
2/13.03.2024
Health conditions studied
1
Description of health condition studied
Impaired balance and falls in elderly
ICD-10 code
R29.6
ICD-10 code description
Repeated falls
Primary outcomes
1
Description
Increase postural stability
Timepoint
Baseline assessment, 2 months after rehabiliation program, follow-up at 6 months
Method of measurement
Index of postural instability measured by Framiral Multitest Equilibre dynamic platform
2
Description
Balance improvement
Timepoint
Baseline assessment, 2 months after rehabiliation program, follow-up at 6 months
Method of measurement
Balance Outcome Measure for Elder Rehabilitation (BOOMER) score
3
Description
Fall risk prevention
Timepoint
baseline assessment, 2 months after rehabiliation program, follow-up at 6 months
Method of measurement
The Falls Efficacy Scale International (FES-I)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consists of elderly subjects, ages 65-85 years old, with a history of 1-3 falls in the last year.
Category
Rehabilitation
2
Description
Control group: The control group consists of subjects with a history of 1-3 falls within the last year. They did not receive the balance and vestibular treatment for various reasons but agreed to undergo the three assessments (baseline, final, and follow-up).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Osteokinetomedica Rehabilitation Center
Full name of responsible person
Doriana Ioana Ciobanu
Street address
No 41, str. Anatole France, Oradea, Bihor, Romania
City
Oradea
Postal code
410482
Phone
+40 722 187 589
Email
doriana.ciobanu@yahoo.com
Web page address
https://osteokinetomedica.ro
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Oradea
Full name of responsible person
Doriana Ioana Ciobanu
Street address
No.1, str. Universitatii, Oradea
City
Oradea
Postal code
410087
Phone
+40 259 408 419
Email
dciobanu@uoradea.ro
Web page address
https://gts.uoradea.ro/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Oradea
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Oradea
Full name of responsible person
Doriana Ioana Ciobanu
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
No.41. str. Anatole France nr.41, Oradea
City
Oradea
Province
Bihor
Postal code
410482
Phone
+40 259 408 419
Email
doriana.ciobanu@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Oradea
Full name of responsible person
Dorina Ianc
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
No.1, str. Universitatii, Oradea
City
Oradea
Province
Bihor
Postal code
410087
Phone
+40 259 408 419
Email
dorina.ianc@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Oradea
Full name of responsible person
Doriana Ioana Ciobanu
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
No.41, str. Anatole France nr.41, Oradea
City
Oradea
Province
Bihor
Postal code
410482
Phone
+40 259 408 419
Email
doriana.ciobanu@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available