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Functional and Physiological Responses to Multicomponent Exercise in Older Adults

2026年8月2日 更新者：Gulsah Sahin、Çanakkale Onsekiz Mart University

Functional and Physiological Responses to a 12-Week Multicomponent Exercise Program in Older Adults: An Exploratory Responder-Non-Responder Analysis

This study will examine functional and physiological responses to a 12-week multicomponent exercise program in community-dwelling older adults. Adults aged 60 to 81 years will be randomly assigned to either a multicomponent exercise group or a control group. The supervised exercise program will be performed twice weekly for 12 weeks and will include aerobic walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Functional performance will be assessed using the six-minute walk test, the 30-second chair stand test, and the 8-Foot Up and Go test at baseline and after 12 weeks. Resting cardiac autonomic function will be assessed using heart rate variability. In addition, an exploratory responder-non-responder analysis will be conducted to examine whether baseline heart rate variability is associated with individual functional adaptations following the exercise program. This study may help identify physiological markers related to functional responsiveness to exercise in older adults.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

40

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。

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • being 60 years of age or older,
  • being able to walk independently,
  • not having any serious cardiovascular, neurological, or musculoskeletal disease that would prevent exercise.
  • do not use medications that may affect autonomic nervous system function
  • Participants with controlled hypertension who were using stable routine medication were eligible, provided that the screening physician considered them medically suitable for exercise participation.

Exclusion Criteria:

  • diagnosed cardiac arrhythmia,
  • uncontrolled hypertension,
  • use of medications that may affect autonomic nervous system function,
  • inability to perform functional performance tests.
  • Uncontrolled hypertension. Regular medication use was reviewed during medical screening. Participants were excluded when a medication or its adverse effects were considered to substantially compromise exercise safety, cardiac rhythm, or the ability to complete the exercise and assessment procedures.

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：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 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：multicomponent Exercise group
Participants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period.
行为的：Multicomponent Exercise Program
Participants in the exercise group will complete a supervised multicomponent exercise program twice weekly for 12 weeks. Each session will last approximately 45 to 50 minutes and include warm-up, aerobic interval walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale and exercise difficulty will be progressively increased by increasing repetitions, walking duration, walking pace, and task complexity.
无干预：Control Group
Participants in the control group will maintain their usual daily activities during the 12-week study period and will not receive the supervised multicomponent exercise program.

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
Change in six-minute walk distance
大体时间：Baseline and 12 weeks
Functional walking capacity will be assessed using the six-minute walk test. The total distance walked in six minutes will be recorded in meters at baseline and after the 12-week intervention.
Baseline and 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in 30-second chair stand test performance
大体时间：Baseline and after 12 weeks
Lower-limb functional strength will be assessed using the 30-second chair stand test at baseline and after the 12-week intervention.
Baseline and after 12 weeks
Change in 8-foot Up-and-Go test performance
大体时间：baseline and after 12 weeks
Functional mobility and agility will be assessed using the 8-Foot Up-and-Go test at baseline and after the 12-week intervention.
baseline and after 12 weeks

其他结果措施

结果测量
措施说明
大体时间
Change in resting heart rate variability parameters
大体时间：Baseline to 12 weeks
Resting heart rate variability parameters will be assessed at baseline as pre-specified exploratory physiological markers associated with individual functional responses to the exercise program.
Baseline to 12 weeks

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。

赞助

Çanakkale Onsekiz Mart University

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 (实际的)

2026年6月1日

初级完成 (估计的)

2026年9月21日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026-YONP-0121

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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