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临床试验/NCT07369440
NCT07369440招募中不适用

Community-based Power Training in Faller and Non-faller Older Adults: a Feasibility and Fall Risk Study.

University of Maia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Neuromuscular Assessments

研究概览

简要总结

Aging leads to substantial alterations in the nervous and skeletal muscle systems that ultimately lead to a reduction in "neural drive" and motor performance. While maximal strength starts declining as early as 50 years of age, aging brings even greater reductions in rate of force development and muscle power, that has been shown to be a stronger predictor of functional independence and balance impairments.

Falls are a major health concern as one third of adults over 65 years loses balance and falls every year, and based on a published report, the estimated health care costs associated with falls in the European Union is €25 billion.

The ability to recover balance declines with aging, where older individuals often recover balance with a greater number of balance recovery steps and non-optimal stepping strategies. In addition, older adults have more difficulty recovering balance in the medio-lateral direction. The hip abductors are fundamental in controlling the motion of the body centre of mass in this direction during weight transfers of standing, stepping, and walking.

Furthermore, these muscles appear to be more susceptible to age-related composition and performance declines than other muscles of the lower limbs, especially in individuals at a higher risk for falls.

Unfortunately, common balance interventions, such as, functional balance training, Tai-Chi, or dance, have a very limited capacity to reduce the risk of falls in older adults. Interestingly, resistance training is relatively better than the mentioned interventions at reducing this problem. This may come about through mitigating the agerelated neuromuscular performance deficits. However, traditional resistance training lacks the emphasis in high velocity movements required for adequate fall prevention protective stepping strategies. Muscle power training is a safe and effective alternative to traditional resistance training. By emphasizing in maximum speed of execution, its results are often better than with traditional resistance training, especially in functional outcomes, with the potential to enhance balance recovery. However, there is little and inconsistent evidence on the optimal exercise parameters (such as velocity) for prevention of falls.

Community-based multi-component exercise programs are often used to promote health and functional benefits in the older adult population. These programs not only have a positive impact in a larger number of communitydwelling individuals, but can also lead to significant improvements. Nonetheless, these programs limited in reducing the risk for falls. Considering the robust effects of muscle power training in the older population, it is conceivable that a multi-component community-based exercise intervention, that focuses on developing muscle power and reduce fall risk, can improve the older individuals' ability to recover balance and consequently, bring greater benefits to the older adult community. However, there is no information on the feasibility of conducting an exercise program to develop muscle power and reduce fall risk in a community-based setting. Furthermore, it is generally unknown if such an exercise intervention can improve function, balance, and reduce the occurrence of falls in older adults especially, among those that have fallen in the past- which are the most relevant target population for both clinical studies and practice.

详细描述

This study will adopt a randomized controlled trial design comparing a community-based multi-component exercise program focused on muscle power (MCP) with a traditional community-based multi-component exercise program (TMC). Equal numbers of older adults with and without a history of falls will be allocated to each intervention group.

  1. Participants

Based on the effect size calculated (0.55-1.75), to achieve a statistical power of 80% with a significance of p smaller than 0.05, this study would need to recruit approximately 22 subjects per group. Anticipating 20% dropout and attrition, and considering this study will propose four different groups, a total of 120 community-dwelling older adults will be recruited from the greater Porto area through existing partnerships with Maia's municipality. Retrospective falls incidence during the 12 months prior to enrollment will be used to classify participants as fallers (n=60) or non-fallers (n=60). Using stratified randomization, participants will be allocated to one of four groups: TMC non-fallers (n=30), TMC fallers (n=30), MCP non-fallers (n=30), or MCP fallers (n=30).

The study will be conducted in accordance with the Declaration of Helsinki of 1975, revised in 2013 and General Data Protection Regulation (GDPR) requirements. Ethical approval will be obtained from the Ethics Committee of the University of Maia prior to participant enrollment. Written informed consent will be obtained from all participants before participation. 2. Procedures

2.1.Screening

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

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

  • Age between 65-85 years;
  • Fall history over the 12 months prior to enrollment (fallers group).

排除标准

  • Any existing medical conditions or injuries which would affect the ability or safety to perform exercise;
  • Taking medication affecting balance (such as sedatives, anti-depressives);
  • Regular (more than 1d/week) participation in resistance training with loading greater than bodyweight during the last year;
  • BMI greater than 32 kg/m2.

研究组 & 干预措施

Traditional Resistance Training in Older Fallers

Experimental

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older fallers will perform a multicomponent exercise program focusing on traditional resistance training.

干预措施: Multi-component exercise program focused on traditional resistance training (Behavioral)

Traditional Resistance Training in Older Non-Fallers

Experimental

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older non-fallers will perform a multicomponent exercise program focusing on traditional resistance training.

干预措施: Multi-component exercise program focused on traditional resistance training (Behavioral)

Power Training in Older Fallers

Experimental

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older fallers will perform a multicomponent exercise program focusing on power training.

干预措施: Multi-component exercise program focused on muscle power (Behavioral)

Power Training in Older Non-Fallers

Experimental

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older non-fallers will perform a multicomponent exercise program focusing on power training.

干预措施: Multi-component exercise program focused on muscle power (Behavioral)

结局指标

主要结局

Neuromuscular Assessments

时间窗: 12 weeks

Handgrip strength was assessed through sustained isometric maximal voluntary contractions (IMVC) using a digital handgrip dynamometer (Gripwisetech, PT). Participants were seated with the shoulder adducted, elbow flexed at 90°, forearm in neutral position and wrist in slight extension. Three maximal isometric contractions of 15 seconds were performed with the dominant hand, with 2 minutes of rest between trials. Maximal force was defined as the highest peak force achieved during the contraction. Rate of force development (RFD) was calculated as the slope of the force-time curve during the initial phase of contraction (0-200 ms). The best trial was used for analysis.

Functional Mobility and Balance

时间窗: 12 weeks

Time to complete four meters at the preferred gait speed (4MWT).

Functional Mobility (TUG).

时间窗: 12 weeks

Time to complete the Timed Up and Go test (seconds).

Functional Mobility under Dual Task

时间窗: 12 weeks

Time to complete the Timed Up and Go test under dual-task conditions (seconds).

次要结局

  • Feasibility (Recruitment Rate)(12 weeks)
  • Feasibility (Intervention Adherence)(12 weeks)
  • Safety (Adverse Events)(12 weeks)
  • Prospective falls incidence(6 months)

研究者

发起方
University of Maia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Óscar Júnio da Silva Ribeiro Requestor Affiliation: Doctor

Doctoral Student

University of Maia

研究点 (1)

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