Comparison of the Effects of Different Exercise Protocols in Frail Elderly Individuals
Comparison of the Effects of Different Exercise Programs on Fall Risk, Fall Fear, and Physical Performance in Frail Geriatric Individuals
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Istanbul, Turkije (Türkiye), 34854
- Marmara University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Volunteering to participate in the study
- Having been diagnosed as frail according to Fried Frail Phenotype (3 or more criteria)
- Being able to walk with or without a walking aid
Exclusion Criteria:
- Being in the terminal stage of illness
- Presence of cognitive impairment (Mini Mental State Assessment score below 24)
- Severe vision and hearing loss
- Acute myocardial infarction (within the last 3-6 months) or unstable angina;
- Uncontrolled atrial or ventricular arrhythmias;
- Aortic dissection aneurysm;
- Severe aortic stenosis;
- Acute endocarditis/pericarditis;
- Uncontrolled high blood pressure (> 180/100 mmHg);
- Acute thromboembolism;
- Acute or severe heart failure;
- Acute or severe respiratory failure;
- Uncontrolled postural hypotension;
- Uncontrolled acute decompensated diabetes or low blood sugar;
- History of fracture within the last 3 months
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Vivifrail Exercise Group
In this group, participants will take part in the Vivifrail Exercise Program, a 12-week multi-component exercise program.
The Vivifrail Exercise Program is a personalized exercise program designed for frail older adults, incorporating various exercise types.
|
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. |
|
Experimenteel: Otago Exercise Group
Participants in this group will be enrolled in a 12-week Otago Exercise Program.
Developed as a fall prevention exercise program, the Otago Exercise Program is one of the most frequently used exercise programs in geriatric individuals.
It is an evidence-based exercise program whose effectiveness has been demonstrated in different geriatric populations.
The Otago Exercise Program includes warm-up exercises, progressive strength and balance exercises, walking sessions, and aerobic exercise.
|
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. |
|
Geen tussenkomst: Control Group
Participants in the control group will be evaluated at the beginning of the study and at the end of 12 weeks.
They will not be included in any exercise program.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mini-BESTest: Balance Evaluation Systems Test
Tijdsspanne: 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'.
|
two weeks
|
|
Falls Efficacy Scale
Tijdsspanne: 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.
|
two weeks
|
|
Short Physical Performance Battery (SPPB)
Tijdsspanne: 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.
|
two weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fear of Falling Questionnaire Revised (FFQ-R)
Tijdsspanne: 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.
|
two weeks
|
|
The Four Square Step Test (FSST)
Tijdsspanne: 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.
|
two weeks
|
|
Nottingham Health Profile
Tijdsspanne: 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.
|
two weeks
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MU-FTR-OSK-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .