Marmara University
Istanbul, 34854, Turkey (Türkiye)
NCT Number: NCT07564076
The aim of this research is to investigate and compare the effects of two different exercise programs developed for frail geriatric individuals on fall risk, fear of falling, and physical performance.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Istanbul, 34854, Turkey (Türkiye)
Frailty is a syndrome characterized by a decline across multiple physiological systems associated with aging. It results in diminished physiological reserve and increased vulnerability to stressors, leading to limitations in activities of daily living. This condition is closely linked to adverse outcomes, including falls, illness, hospitalization, and mortality. The frailty phenotype is generally defined by five criteria: weight loss, exhaustion, low grip strength, slowness, and reduced physical activity. The presence of three or more of these criteria indicates frailty, while one or two criteria signify a pre-frail state. Research indicates that frail geriatric individuals face a significantly higher risk of falling compared to their non-frail peers. Furthermore, a heightened fear of falling is associated with an increased risk of frailty. Consequently, prioritizing frailty management in geriatric care is essential for mitigating fall risks.
Exercise interventions have been shown to produce positive effects on physical function and quality of life in frail older adults. By improving muscle mass and strength, exercise plays a pivotal role in the treatment of frailty. Various exercise programs specifically designed as fall prevention strategies are recommended for this population. Notably, the frailty status of elderly individuals residing in nursing homes requires greater clinical attention compared to those living in the community. Nursing home residents often exhibit lower physical activity levels and a higher need for structured exercise interventions. Investigating and comparing the effectiveness of different exercise programs for this vulnerable group is crucial for selecting the most efficient protocols to reduce fall risks and enhance physical performance.
The Otago Exercise Program (OEP) is a well-established, evidence-based fall prevention protocol frequently utilized in geriatric care. It comprises warming up, progressive strengthening and balance exercises, walking sessions, and aerobic components. OEP has the potential to delay or even reverse frailty while improving the overall health status of participants. Current evidence suggests that OEP can reduce frailty, increase grip strength, and improve balance and mobility in frail and pre-frail individuals, although its impact on quality of life remains less certain. Despite its widespread use, there is a need for more robust study designs to confirm its efficacy, particularly regarding its effects on the fear of falling, where existing research is limited.
In addition, multicomponent exercise programs-which integrate strengthening, balance, aerobic, and flexibility training within a single session-are considered a viable and effective alternative for geriatric populations. Such programs are recommended as part of routine clinical practice for frail or sedentary individuals. A prominent example is the Vivifrail project, developed by international experts to provide personalized exercise prescriptions for preventing frailty and falls. In the Vivifrail program, the exercise regimen is tailored to the individual's functional status and fall risk, encompassing strength, balance, flexibility, and cardiovascular endurance. Studies have demonstrated that Vivifrail can reverse functional decline associated with hospitalization and improve functional capacity in older women with dynapenia as well as in frail individuals with mild cognitive impairment. The program is noted for its ease of implementation, offering a quick assessment to guide exercise prescription.
Currently, there is a paucity of research regarding the impact of the Vivifrail program on fall risk and the fear of falling in frail geriatric individuals. Similarly, further high-quality studies are required to fully establish the benefits of OEP in this population. Furthermore, there is a notable gap in the literature regarding direct comparisons between the Vivifrail and Otago programs. Therefore, this study is designed to investigate and compare the effects of these two distinct exercise protocols on fall risk, fear of falling, and physical performance among frail geriatric individuals residing in nursing homes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following an initial assessment and random assignment to exercise groups, participants will undergo a multicomponent exercise program (Vivifrail) consisting of 60 sessions, 5 days a week, for 12 weeks. Each session will last approximately 60 minutes and will be conducted on two non-consecutive days with a physiotherapist present, and on the other three days following instructions given by the physiotherapist and patient education. The program will be supervised by the institution's physician, who is also a researcher in the study, and will include an organization that can provide emergency assistance if needed.
Participants will be provided with the necessary equipment for the exercises (resistance bands, towels, and water bottles). Attendance at exercise sessions will be recorded.
The Otago Exercise Program (OEP) consists of balance and strengthening exercises and walking exercises. Each exercise session in the OEP begins with 5-7 minutes of light warm-up exercises and continues with approximately 30-35 minutes of strengthening and balance exercises. Additionally, participants are included in moderate-paced walking sessions for 30 minutes at least twice a week on days when the exercise program is not in progress. The number of repetitions, frequency, intensity, and duration of the exercises are planned individually for each participant.
In our study, balance and strengthening exercises will be performed twice a week in a group setting with a physiotherapist. Each group will consist of 4-5 participants with similar physical capacity and function.
Time frame: two weeks
Developed by Franchignoni et al. in 2010, the Mini-BESTest consists of four groups: pre-postural preparation, reactive postural responses, sensory orientation, and gait balance. The test contains 14 items, each scored between 0 and 2. '0' represents the lowest functional level, and '2' represents the highest. The lowest possible score on the Mini-BESTest is '0', and the highest is '28'.
Time frame: two weeks
This scale, developed by Yardley et al. in 2005, assesses fear of falling. The FFS consists of 16 items, each scored from 1 to 4. The total score ranges from 16 to 24, with a higher score indicating greater fear of falling.
Time frame: two weeks
Guralnik et al. developed this test by combining balance, timed up and go, and walking speed tests. The first test assesses static balance in three standing positions, the second test assesses lower extremity strength and power after standing and sitting in a chair, and the third test assesses walking speed at a normal pace. Each test is scored from 0 (failure to perform the task) to 4 points (best test performance). The total score is between 0 and 12. A high score is considered good performance.
Time frame: two weeks
Developed by Bower et al. in 2015, it consists of six items. Each item is scored between 1 and 4 points. The total score ranges from 6 to 24 points. Higher scores indicate a greater fear of falling.
Time frame: two weeks
This test, developed by Dite and Temple, is used to assess balance in older adults. The test involves placing a bar on a flat surface to create four squares, each numbered. Participants are instructed to start at the first square (with their faces towards the second square), step clockwise and then counterclockwise as quickly as possible without touching the bars, ensuring both feet touch the ground at each square. The time taken to complete the test is recorded as a score. Higher times indicate poorer performance, while higher scores indicate a greater fear of falling.
Time frame: two weeks
439 The scale assesses six health-related dimensions and has 38 items. It evaluates quality of life by questioning the problems a person may have encountered in the past week. The sub-dimensions are energy, pain, emotional reactions, sleep, social isolation, and physical activity. Each dimension is scored between 0 and 100 points. The total score ranges from 0 to 600 points. Higher scores indicate worse health status.
Marmara University
Other
Comparison of the Effects of Different Exercise Programs on Fall Risk, Fall Fear, and Physical Performance in Frail Geriatric Individuals
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