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Effects of Resistance-Based Multicomponent Training Incorporating Respiratory Exercise on Diaphragm Thickness, Hepatic Attenuation, and Quality of Life in Healthy Older Men: A Randomized Controlled Trial (RT-DIA-OLDER)

2026年9月25日 更新者:Coşkun YILMAZ、Gümüşhane Universıty

This randomized controlled trial investigated the effects of a four-week moderate-intensity resistance training program on diaphragm thickness, hepatic fat density, and health-related quality of life in healthy community-dwelling older men aged 60-75 years. Thirty participants were randomly assigned to a resistance training group or control group. Diaphragm thickness and hepatic attenuation were assessed using non-contrast computed tomography, and quality of life was evaluated using the SF-12 questionnaire. The primary outcome was change in diaphragm thickness. Secondary exploratory outcomes included hepatic fat density and SF-12 physical and mental health scores.

研究概览

详细说明

Aging is associated with progressive decline in respiratory muscle morphology, metabolic health, and perceived quality of life. While resistance training is well established for peripheral muscle adaptation, its short-term effects on diaphragm morphology and hepatic tissue density remain insufficiently investigated.

This randomized controlled pre-test-post-test trial enrolled 30 healthy men aged 60-75 years. Participants were randomly allocated (1:1) to:

Resistance Training Group (RT) Control Group (CON) The RT group completed a supervised moderate-intensity resistance training program three times per week for four weeks (30-40 minutes/session, RPE 12-15). The control group maintained usual daily activities.

Primary Outcome:

Change in diaphragm thickness (mm) assessed by non-contrast CT

Secondary Outcomes (Exploratory):

Hepatic attenuation (Hounsfield Units) via CT SF-12 Physical Health Score SF-12 Mental Health Score The study was approved by the Hitit University Scientific Research Ethics Committee (2025/0464) and conducted according to the Declaration of Helsinki.

研究类型

介入性

注册 (实际的)

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。

学习地点

    • Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane
      • Gümüşhane、Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane、土耳其(türkiye)、29600
        • Gumushane Univetsity

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

60年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male
  • Age 60-75 years
  • Community-dwelling and functionally independent
  • No structured exercise program in past 6 months
  • No musculoskeletal injury in past 6 months
  • Ability to provide written informed consent
  • Stable neuropsychological status

Exclusion Criteria:

  • Chronic liver disease
  • Uncontrolled cardiovascular or pulmonary disease
  • Recent respiratory infection
  • Use of medications affecting muscle or liver metabolism (e.g., systemic corticosteroids, anabolic agents, hepatotoxic drugs)
  • Participation in structured exercise or respiratory training within past 6 months
  • Unstable thyroid hormone replacement therapy

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Resistance Training Group (RT)

Participants performed supervised resistance training three times per week for four weeks. Each session lasted 30-40 minutes and included:

Lower body exercises (sit-to-stand, step-ups, glute bridge) Upper body exercises (wall push-ups, resistance band row, biceps curl) Core exercises Breathing exercises (diaphragmatic breathing, pursed-lip breathing) Warm-up protocol (10 minutes dynamic mobility) Intensity: Borg RPE 12-15 Rest interval: 60 seconds between sets

Structured Moderate-Intensity Resistance Training

Participants maintained their usual daily routines without structured exercise intervention.

无干预:CONTROL

Participants maintained their usual daily routines without structured exercise intervention.

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
Diaphragm Thickness
大体时间:4 weeks

Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.

4 weeks

次要结果测量

结果测量
措施说明
大体时间
Hepatic Fat Density
大体时间:4 weeks

Measurement: CT attenuation (Hounsfield Units) Single ROI in segment VIII

4 weeks
SF-12 Physical Health Score
大体时间:4 weeks

Instrument: Short Form-12 Health Survey The physical and mental health scores of the SF-12 subdimensions range from 0 to 100, with higher scores representing better health.

4 weeks
SF-12 Mental Health Score
大体时间:4 weeks

Instrument: Short Form-12 Health Survey The physical and mental health scores of the SF-12 subdimensions range from 0 to 100, with higher scores representing better health.

4 weeks
Six-minute walk test (6MWT)
大体时间:4 WEEK

Functional exercise capacity was assessed using the 6-Minute Walk Test (6MWT) according to a standardised protocol based on established 6MWT recommendations. The test was performed on a flat, straight 30-m indoor corridor, with the course clearly marked at both ends. Participants were instructed to walk back and forth along the corridor for 6 min at a self-selected walking pace, with the objective of covering the greatest possible distance within the allotted time.

4 WEEK

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。

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3月10日

初级完成 (实际的)

2026年4月25日

研究完成 (实际的)

2026年5月30日

研究注册日期

首次提交

2026年2月27日

首先提交符合 QC 标准的

2026年2月27日

首次发布 (实际的)

2026年3月4日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • E-95674917-108.99-181733

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to the absence of prior consent for data sharing and the potential risk of re-identification in a small, single-center sample. Only aggregate results will be disseminated.

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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