Comparison of the Effects of Different Exercise Protocols in Frail Elderly Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivifrail Exercise Program, Otago Exercise Program.
- Who it may be relevant to
- Registry conditions: Frail Elderly. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effects of Different Exercise Programs on Fall Risk, Fall Fear, and Physical Performance in Frail Geriatric Individuals
Overview
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.
Detailed description
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.
Interventions
- Other Vivifrail Exercise Program
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, wh - Other Otago Exercise Program
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 durati
Primary outcome measures
- Mini-BESTest: Balance Evaluation Systems Test [Time frame: two weeks]
- Falls Efficacy Scale [Time frame: two weeks]
- Short Physical Performance Battery (SPPB) [Time frame: two weeks]
Secondary outcome measures (3)
- Fear of Falling Questionnaire Revised (FFQ-R) [Time frame: two weeks]
- The Four Square Step Test (FSST) [Time frame: two weeks]
- Nottingham Health Profile [Time frame: two weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Marmara University — Istanbul
Identifiers
NCT: NCT07564076 · MU-FTR-OSK-01