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临床试验/NCT07564076
NCT07564076Enrolling By Invitation不适用

Comparison of the Effects of Different Exercise Programs on Fall Risk, Fall Fear, and Physical Performance in Frail Geriatric Individuals

Marmara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Mini-BESTest: Balance Evaluation Systems Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be kept unaware of which exercise program they will be enrolled in. Additionally, the statistical analysis will be performed by a researcher blinded to the treatment allocation.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Vivifrail Exercise Group

Experimental

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.

干预措施: Vivifrail Exercise Program (Other)

Otago Exercise Group

Experimental

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.

干预措施: Otago Exercise Program (Other)

Control Group

No Intervention

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.

结局指标

主要结局

Mini-BESTest: Balance Evaluation Systems Test

时间窗: 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'.

Falls Efficacy Scale

时间窗: 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.

Short Physical Performance Battery (SPPB)

时间窗: 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.

次要结局

  • Fear of Falling Questionnaire Revised (FFQ-R)(two weeks)
  • The Four Square Step Test (FSST)(two weeks)
  • Nottingham Health Profile(two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Onur Körtelli

Doctoral Student

Marmara University

研究点 (1)

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