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Effects of a Smart Circuit Exercise Program on Health Outcomes in Community-Dwelling Older Adults

2026年8月24日 更新者:Chang Gung Memorial Hospital

Intelligent Precision Exercise Integrated Health Management: Construction of Innovative Technology and Management Models and Clinical Evidence Research in Elderly Communities.

This study was conducted in collaboration with a community-based retirement facility to evaluate the clinical effectiveness of a smart, technology-assisted circuit exercise intervention for community-dwelling older adults. Traditional exercise prescriptions for older adults often lack real-time monitoring of individual physiological responses, which can increase the risk associated with exercise participation. This program integrated real-time physiological monitoring (including heart rate reserve, HRR) to guide individualized exercise intensity within a moderate-intensity range (50%-60% HRR).

The study was conducted in two stages with different allocation designs:

Stage 1 (Randomized Controlled Design): Participants were randomly assigned to either an intervention group or a control group. The intervention group received the smart circuit exercise program, while the control group did not receive the exercise intervention and underwent pre- and post-assessment only. This stage allowed for between-group comparison of intervention effects.

Stage 2 (Single-Group Extension): Following completion of Stage 1, the facility extended the exercise program to a broader group of community residents as part of a real-world implementation and scale-up initiative, in order to evaluate the program under routine practice conditions and to provide equitable access to the intervention across the community. A concurrent control group was not maintained during this stage, consistent with its focus on real-world effectiveness evaluation rather than efficacy comparison.

Participants in both stages received circuit-based exercise training three times per week (24 sessions total over approximately 8 weeks), with intensity controlled at 50%-60% heart rate reserve (HRR).

Outcome measures assessed before and after the intervention period included: cardiac autonomic activity and hemodynamic function (including blood pressure and heart rate variability), arterial stiffness, body composition (including skeletal muscle mass, body fat mass, and body fat percentage), functional fitness (including lower limb muscle strength and dynamic balance), clinical blood biochemistry indicators (including HbA1c), depressive symptoms (CESD-10), and sleep quality (Pittsburgh Sleep Quality Index, PSQI).

Statistical analyses varied by stage and publication. For Stage 1 between-group comparisons, linear mixed models (LMM) with participant as a random intercept were used to test Time × Group interactions, adjusting for age, sex, and height. For broader cohort analyses, two-way mixed-design analysis of variance and paired-samples t-tests were used. Statistical significance was set at alpha = .05 for all analyses.

研究概览

详细说明

This study was conducted in collaboration with a community-based retirement facility to evaluate the clinical effectiveness of a smart, technology-assisted circuit exercise intervention for community-dwelling older adults. Traditional exercise prescriptions for older adults often lack real-time monitoring of individual physiological responses, which can increase the risk associated with exercise participation. This program integrated real-time physiological monitoring (including heart rate reserve, HRR) to guide individualized exercise intensity within a moderate-intensity range (50%-60% HRR).

The study was conducted in two stages with different allocation designs:

Stage 1 (Randomized Controlled Design): Participants were randomly assigned to either an intervention group or a control group. The intervention group received the smart circuit exercise program, while the control group did not receive the exercise intervention and underwent pre- and post-assessment only. This stage allowed for between-group comparison of intervention effects.

Stage 2 (Single-Group Extension): Following the completion and analysis of Stage 1, which demonstrated the safety and preliminary effectiveness of the smart circuit exercise program, the facility extended the program to a broader group of community residents as part of a real-world implementation and scale-up initiative, in order to evaluate the program's effectiveness under routine practice conditions and to provide equitable access to the intervention across the community. A concurrent control group was not maintained during this stage, consistent with its focus on real-world effectiveness evaluation rather than efficacy comparison.

Participants in both stages received circuit-based exercise training three times per week (24 sessions total across approximately 8 weeks), with intensity controlled at 50%-60% heart rate reserve (HRR).

Outcome measures assessed before and after the intervention period included: body composition (including skeletal muscle mass, body fat mass, and body fat percentage), blood pressure, functional fitness (lower limb muscle strength and dynamic balance), clinical blood biochemistry indicators (including HbA1c), depressive symptoms (CESD-10), and sleep quality (Pittsburgh Sleep Quality Index, PSQI).

Statistical analyses included two-way mixed-design analysis of variance and paired-samples t-tests, with statistical significance set at alpha = .05. Stage 1 data were analyzed as a between-group comparison. Stage 2 data were analyzed independently as a within-group pre-post comparison and were not statistically compared to the Stage 1 control group, given the non-concurrent recruitment timing between stages.

Note: This trial is being registered retrospectively. The study was conducted and closed under IRB approval prior to the decision to pursue publication in international peer-reviewed journals, at which point trial registration was completed.

研究类型

介入性

注册 (实际的)

256

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

    • Guishan
      • Taoyuan、Guishan、台湾、33371
        • Chang Gung University

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

  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Age 65 to 85 years, community-dwelling
  • Able to walk independently, without assistance
  • Able to understand study procedures in Mandarin or Taiwanese and voluntarily provide informed consent
  • Willing to undergo health examinations and testing, and to provide historical health examination records
  • Completed a health status questionnaire covering medical history, medication use, and comorbidities
  • Physical Activity Readiness Questionnaire Plus (PAR-Q+) results indicating suitability for exercise training (or written physician clearance obtained if any positive response)
  • Completed the International Physical Activity Questionnaire (IPAQ), with results not meeting the criterion for regular exercise within the past 6 months (i.e., fewer than 2 sessions/week or less than 30 minutes/session of moderate-intensity aerobic exercise)

Exclusion Criteria:

  • Cognitive impairment or dementia precluding understanding of study procedures or compliance with test instructions
  • Lower-extremity fracture, joint surgery, or joint replacement within the past 3 months precluding safe completion of sit-to-stand or walking tasks
  • Severe joint pain precluding safe completion of baseline test movements, as assessed by study personnel
  • Unexplained syncope or fall history within the past 3 months, or safety concerns as assessed by study personnel
  • Acute illness (e.g., fever, acute infection)
  • Cardiac pacemaker or incompatible metal implants affecting bioelectrical impedance analysis (BIA) measurement safety
  • Meeting the criterion for regular exercise within the past 6 months per the International Physical Activity Questionnaire (IPAQ) (≥2 sessions/week, ≥30 minutes/session of moderate-intensity aerobic exercise)
  • Physical Activity Readiness Questionnaire Plus (PAR-Q+) screening results indicating unsuitability for exercise training, without written physician clearance
  • Unstable cardiovascular disease, including unstable angina, uncontrolled atrial or ventricular arrhythmia, uncontrolled resting sinus tachycardia (>120 beats/min), decompensated congestive heart failure, third-degree atrioventricular block without a pacemaker, acute pericarditis or myocarditis, or recent thrombosis/thrombophlebitis
  • Uncontrolled diabetes (HbA1c > 9%, resting blood glucose > 300 mg/dL, or > 250 mg/dL with ketosis) or poorly controlled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
  • Use of medications that may interfere with muscle metabolism (e.g., high-dose corticosteroids, immunosuppressants)
  • Symptomatic orthostatic hypotension (blood pressure drop > 20 mmHg)
  • Resting ST-segment depression > 2 mm
  • Severe neurological or musculoskeletal disease precluding safe performance of study procedures, as assessed by study personnel
  • Currently participating in another clinical trial involving an exercise intervention
  • Severe anemia, acute infectious disease, or other physiological conditions deemed unsuitable for exercise training by the investigator

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:预防
  • 分配:非随机化
  • 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:Arm 1_Stage 1 - Intervention Group
Participants randomly assigned to receive the smart circuit exercise program during Stage 1. Sessions were held 3 times per week (24 sessions total over approximately 8 weeks), with exercise intensity controlled at 50%-60% heart rate reserve (HRR) using real-time physiological monitoring. (n=50 enrolled, n=50 completed)
A moderate-intensity circuit-based exercise program incorporating real-time physiological monitoring (including heart rate reserve, HRR) to guide individualized exercise intensity. Sessions were held 3 times per week (24 sessions total over approximately 8 weeks), with intensity controlled at 50%-60% HRR.
无干预:Arm 2_Stage 1 - Control Group
Participants randomly assigned to the control group during Stage 1. Participants did not receive the exercise intervention and underwent pre- and post-assessment only. (n=50 enrolled, n=46 completed)
实验性的:Arm 3_Stage 2 - Intervention Extension (Single-Group)
Following completion and analysis of Stage 1, additional community residents were enrolled to receive the same smart circuit exercise program as part of a real-world implementation and scale-up initiative. No concurrent control group was maintained during this stage. (n=156 enrolled, n=142 completed)
A moderate-intensity circuit-based exercise program incorporating real-time physiological monitoring (including heart rate reserve, HRR) to guide individualized exercise intensity. Sessions were held 3 times per week (24 sessions total over approximately 8 weeks), with intensity controlled at 50%-60% HRR.

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 Time-Domain Heart Rate Variability
大体时间:Baseline and up to 12 weeks
Standard deviation of NN intervals (SDNN) and root mean square of successive differences (RMSSD), derived from 4-minute seated ECG recording, reported in milliseconds.
Baseline and up to 12 weeks
Change in Frequency-Domain Heart Rate Variability
大体时间:Baseline and up to 12 weeks
Normalized low-frequency (nLF) and high-frequency (nHF) power, derived from 4-minute seated ECG recording, reported in normalized units.
Baseline and up to 12 weeks
Change in Dynamic Heart Rate Variability Reactivity
大体时间:Baseline and up to 12 weeks
E/I ratio (from 2-minute deep breathing), Valsalva ratio (from 2-minute Valsalva maneuver), and 30:15 ratio (from 2-minute standing), each reported as a ratio.
Baseline and up to 12 weeks
Change in Blood Pressure
大体时间:Baseline and up to 12 weeks
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and pulse pressure (PP), measured via upper-arm automatic blood pressure monitor, average of 3 consecutive readings, reported in mmHg.
Baseline and up to 12 weeks
Change in Rate-Pressure Product
大体时间:Baseline and up to 12 weeks
Cardiac load index calculated as heart rate multiplied by systolic blood pressure, reported in bpm·mmHg.
Baseline and up to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Skeletal Muscle Mass and Body Fat Mass
大体时间:Baseline and up to 12 weeks
Skeletal muscle mass (SMM) and body fat mass (BFM), reported in kg.
Baseline and up to 12 weeks
Change in Percent Body Fat
大体时间:Baseline and up to 12 weeks
Percent body fat (PBF), reported as a percentage.
Baseline and up to 12 weeks
Change in Body Mass Index
大体时间:Baseline and up to 12 weeks
Body mass index (BMI), calculated from body composition analysis, reported in kg/m^2.
Baseline and up to 12 weeks
Change in Waist-Hip Ratio
大体时间:Baseline and up to 12 weeks
Waist-hip ratio (WHR), reported as a ratio.
Baseline and up to 12 weeks
Change in Visceral Fat Area
大体时间:Baseline and up to 12 weeks
Visceral fat area (VFA), reported in cm^2.
Baseline and up to 12 weeks
Change in Digital Volume Pulse Stiffness Index
大体时间:Baseline and up to 12 weeks
Stiffness Index (SI), derived from photoplethysmography-based digital volume pulse (DVP) pulse contour analysis, reported in m/s.
Baseline and up to 12 weeks
Change in Digital Volume Pulse Contour Reflection Index
大体时间:Baseline and up to 12 weeks
Reflection Index (RI), derived from pulse contour analysis of the digital volume pulse (DVP) waveform, reported as a ratio.
Baseline and up to 12 weeks
Change in Second-Derivative Photoplethysmogram Amplitude Ratios
大体时间:Baseline and up to 12 weeks
Second-derivative photoplethysmogram (SDPTG) amplitude ratios (b/a, c/a, d/a, e/a), derived from second-derivative analysis of the digital volume pulse (DVP) waveform, reported as a ratio.
Baseline and up to 12 weeks
Change in Augmentation Index
大体时间:Baseline and up to 12 weeks
Augmentation Index (AIx) and heart-rate-normalized Augmentation Index (AIx@75), derived from DVP pulse contour analysis, reported as a percentage.
Baseline and up to 12 weeks
Change in Aging Index
大体时间:Baseline and up to 12 weeks
Aging Index (AGI), derived from second-derivative photoplethysmogram (SDPTG) analysis, reported in arbitrary units.
Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Muscular Strength
大体时间:Baseline and up to 12 weeks
Lower-limb strength (LowerStr), assessed using the 30-Second Chair Stand Test, and upper-limb strength (UpperStr), assessed using the 30-Second Arm Curl Test, reported in repetitions.
Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Flexibility
大体时间:Baseline and up to 12 weeks
Lower-limb flexibility (LowerFlex), assessed using the Chair Sit-and-Reach Test, and upper-limb flexibility (UpperFlex), assessed using the Back Scratch Test, reported in cm.
Baseline and up to 12 weeks
Change in Cardiorespiratory Endurance
大体时间:Baseline and up to 12 weeks
Cardiorespiratory endurance assessed using a 2-minute step test, reported in number of steps.
Baseline and up to 12 weeks
Change in Dynamic and Static Balance
大体时间:Baseline and up to 12 weeks
Dynamic balance (DynBal), assessed using the Timed Up-and-Go Test, and static balance (StatBal), assessed using the Single-Leg Stance Test (eyes open), reported in seconds.
Baseline and up to 12 weeks
Change in HbA1c
大体时间:Baseline and up to 12 months following study completion
Glycated hemoglobin (HbA1c), based on voluntary submission of participants' individual routine health examination reports. Assessment timing and laboratory were not standardized by the study protocol, as this measure relied on participant-provided documentation rather than investigator-administered blood collection. Reported as a percentage.
Baseline and up to 12 months following study completion
Change in Lipid Profile
大体时间:Baseline and up to 12 months following study completion
Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), based on voluntary submission of participants' individual routine health examination reports at any point up to 12 months following study completion. Assessment timing and laboratory were not standardized by the study protocol, as this measure relied on participant-provided documentation rather than investigator-administered blood collection. Reported in mg/dL.
Baseline and up to 12 months following study completion

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:Jong-Shyan WANG, Ph.D.、Chang Gung University, Guishan, Taoyuan 333

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2024年5月10日

初级完成 (实际的)

2026年2月27日

研究完成 (实际的)

2026年2月28日

研究注册日期

首次提交

2026年8月20日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 202601236B0
  • FCRPD1P0021 (其他赠款/资助编号:Wang Chang-Gung Charitable Trust Fund)

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 that underlie the results reported in publications arising from this study may be made available to other researchers upon reasonable request to the corresponding author, subject to appropriate institutional and ethics committee approvals.

IPD 共享时间框架

Beginning after publication, with no defined end date, upon reasonable request.

IPD 共享访问标准

Requests will be reviewed by the corresponding author and require institutional/ethics approval where applicable.

IPD 共享支持信息类型

  • 研究方案

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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