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Eccentric Exercise in Community-dwelling Older Adults (HEX:AGEUK)

2026年10月29日 更新者:Brett Baxter、The University of Northampton

The Effects of an Eccentric-biased Strengthening Programme Delivered to Community-dwelling Older Adults"

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a 12-month eccentric-biased strengthening programme in community-dwelling older adults aged 65 years and older. The main questions it aims to answer are:

Can an eccentric-biased strengthening programme be feasibly delivered to community-dwelling older adults in a community setting? Does participation in the programme improve functional mobility, lower-limb strength, falls self-efficacy, and health-related quality of life?

Participants will:

Attend a 12-month supervised eccentric-biased strengthening programme delivered in a community setting.

Complete assessments of functional mobility, lower-limb strength, falls self-efficacy, and health-related quality of life before and after the intervention.

Provide information regarding their experience of participating in the programme to evaluate its acceptability.

研究概览

地位

尚未招聘

条件

详细说明

Age-related declines in muscle strength, power, and physical function contribute to reduced mobility, loss of independence, and an increased risk of falls among older adults. Resistance exercise is recommended to mitigate these declines; however, conventional exercise programmes may be limited by physical capacity, fatigue, or accessibility. Eccentric muscle actions allow greater force production at a lower metabolic cost and may therefore represent an effective and practical training modality for older adults.

This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a community-based eccentric-biased strengthening programme delivered to community-dwelling older adults. Participants will be recruited through community organisations and complete a 12-month supervised exercise intervention designed to improve lower-limb strength and functional performance.

Feasibility will be evaluated through recruitment, retention, attendance, adherence, and adverse event monitoring. Acceptability will be assessed through participant feedback and experiences of programme participation. Preliminary effectiveness will be explored through changes in measures of physical function, falls-related self-efficacy, and health-related quality of life collected before and after the intervention.

The findings will provide evidence regarding the practicality of delivering an eccentric-biased strengthening programme within a community setting and will inform the design of future adequately powered controlled studies investigating the effectiveness of eccentric exercise interventions in older adults.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Northamptonshire
      • Northampton、Northamptonshire、英国、NN1 5PH
        • University of Northampton

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Age ≥ 65 years Ambulant with or without a walking aid

Exclusion Criteria:

  • Inability to provide informed consent, assessed using the Mental Capacity Act two-stage assessment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

Eccentric exercise programme

Participants will undertake a 12-month supervised eccentric-biased strengthening programme delivered in a community setting, with the option of performing this at home. The intervention will consist of 6x 1-minute progressive lower-limb strengthening exercises emphasising the eccentric phase of movement, including functional tasks relevant to activities of daily living. Exercise difficulty will be progressively increased throughout the programme according to participant performance and tolerance. Community sessions will be led by staff at the community setting who will have been educated and trained by developers of the exercise programme in a group-based format. The intervention is designed to improve lower-limb strength, mobility, balance confidence, and physical function in community-dwelling older adults.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility of Intervention Recruitment
大体时间:Up to 12 months

Feasibility of recruitment will be assessed through participant recruitment capacity, calculated as the number of participants enrolled on the study relative to total number of people invited to take part.

Up to 12 months
Feasibility of Intervention Delivery
大体时间:Up to 12 months

Feasibility of delivery will be assessed through participant partiicpant adherence to the intervention, calculated as the number of sessions attended relative to the total number of sessions presrcibed.

Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Timed Up and Go Test
大体时间:Up to 12 months

Timed Up and Go test wil require participants to rise from a chair, walk three metres, turn around, return to the chair, and sit down. The time taken to complete the test will be recorded in seconds.

Up to 12 months
Sit-to-stand Test
大体时间:Up to 12 months

Lower-limb strength will be assessed using the Five Times Sit-to-Stand test. Participants will be asked to stand up and sit down five times as quickly as possible from a standard chair without using their arms for assistance. Time to completion will be recorded in seconds.

Up to 12 months
Falls Efficacy Scale International
大体时间:Up to 12 months

The Falls Efficacy Scale International (FES-I) will be used to assess the fear of falling. The FES-I is a validated self-report questionnaire that evaluates an individual's concern about falling during a range of everyday activities. Higher scores indicate greater concern about falling.

Up to 12 months
EuroQol Five-Dimension Five-Level Questionnaire
大体时间:Up to 12 months

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. The instrument evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, alongside a self-rated health visual analogue scale.

Up to 12 months
Intervention Acceptability
大体时间:Up to 12 months

Participant acceptability of the eccentric-biased strengthening programme will be assessed through post-intervention feedback. Information regarding participant satisfaction, perceived benefits, barriers to participation, and willingness to continue exercise following programme completion will be collected.

Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brett A. Baxter, PhD、University of Northampton

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月23日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年10月22日

首先提交符合 QC 标准的

2026年10月29日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data for all primary and secondary outcome measures reported in study publications will be made available. This includes baseline and post-intervention values for TUG, 5×STS, Short FES-I, EQ-5D-5L, and intervention adherence metrics. No personally identifiable information will be shared.

IPD 共享时间框架

IPD will be available indefinitely as it will be stored on a public resposiotory (PURE).

IPD 共享访问标准

Public

IPD 共享支持信息类型

  • 研究方案
  • 树液

研究数据/文件

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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