AgingNCT07790263
Effects of a Smart Circuit Exercise Program on Health Outcomes in Community-Dwelling Older Adults
A study testing Smart Circuit Exercise Program in people with Aging and Autonomic Nervous System, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Autonomic Nervous System, Hemodynamics
- What is being tested?
- Smart Circuit Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Aging, Autonomic Nervous System, Hemodynamics
- Being tested
- Smart Circuit Exercise Program
- Keywords
- Aerobic exercise, Circuit training, Heart rate variability, Arterial stiffness, Blood pressure, Older adults, Digital health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Circuit Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1_Stage 1 - Intervention Group | Experimental | 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) Receives: Behavioral: Smart Circuit Exercise Program |
| Arm 2_Stage 1 - Control Group | No intervention | 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) |
| Arm 3_Stage 2 - Intervention Extension (Single-Group) | Experimental | 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) Receives: Behavioral: Smart Circuit Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time-Domain Heart Rate Variability
Standard deviation of NN intervals (SDNN) and root mean square of successive differences (RMSSD), derived from 4-minute seated ECG recording, reported in milliseconds.
Measured: Baseline and up to 12 weeks
Change in Frequency-Domain Heart Rate Variability
Normalized low-frequency (nLF) and high-frequency (nHF) power, derived from 4-minute seated ECG recording, reported in normalized units.
Measured: Baseline and up to 12 weeks
Change in Dynamic Heart Rate Variability Reactivity
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.
Measured: Baseline and up to 12 weeks
Change in Blood Pressure
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.
Measured: Baseline and up to 12 weeks
Change in Rate-Pressure Product
Cardiac load index calculated as heart rate multiplied by systolic blood pressure, reported in bpm·mmHg.
Measured: Baseline and up to 12 weeks
Secondary outcomes (16)
Change in Skeletal Muscle Mass and Body Fat Mass
Skeletal muscle mass (SMM) and body fat mass (BFM), reported in kg.
Measured: Baseline and up to 12 weeks
Change in Percent Body Fat
Percent body fat (PBF), reported as a percentage.
Measured: Baseline and up to 12 weeks
Change in Body Mass Index
Body mass index (BMI), calculated from body composition analysis, reported in kg/m^2.
Measured: Baseline and up to 12 weeks
Change in Waist-Hip Ratio
Waist-hip ratio (WHR), reported as a ratio.
Measured: Baseline and up to 12 weeks
Change in Visceral Fat Area
Visceral fat area (VFA), reported in cm^2.
Measured: Baseline and up to 12 weeks
Change in Digital Volume Pulse Stiffness Index
Stiffness Index (SI), derived from photoplethysmography-based digital volume pulse (DVP) pulse contour analysis, reported in m/s.
Measured: Baseline and up to 12 weeks
Change in Digital Volume Pulse Contour Reflection Index
Reflection Index (RI), derived from pulse contour analysis of the digital volume pulse (DVP) waveform, reported as a ratio.
Measured: Baseline and up to 12 weeks
Change in Second-Derivative Photoplethysmogram Amplitude Ratios
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.
Measured: Baseline and up to 12 weeks
Change in Augmentation Index
Augmentation Index (AIx) and heart-rate-normalized Augmentation Index (AIx@75), derived from DVP pulse contour analysis, reported as a percentage.
Measured: Baseline and up to 12 weeks
Change in Aging Index
Aging Index (AGI), derived from second-derivative photoplethysmogram (SDPTG) analysis, reported in arbitrary units.
Measured: Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Muscular Strength
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.
Measured: Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Flexibility
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.
Measured: Baseline and up to 12 weeks
Change in Cardiorespiratory Endurance
Cardiorespiratory endurance assessed using a 2-minute step test, reported in number of steps.
Measured: Baseline and up to 12 weeks
Change in Dynamic and Static Balance
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.
Measured: Baseline and up to 12 weeks
Change in HbA1c
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.
Measured: Baseline and up to 12 months following study completion
Change in Lipid Profile
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.
Measured: Baseline and up to 12 months following study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start10 May 2024
- Primary completion27 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employed a two-stage design. Stage 1 used a parallel-group randomized design, with participants randomly assigned to an intervention or control group. Stage 2 was a single-group, non-randomized extension in which additional participants received the intervention without a concurrent control group, conducted to evaluate real-world program effectiveness following the completion of Stage 1.
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Shyan WANG, Ph.D., Principal investigator, Chang Gung University, Guishan, Taoyuan 333
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790263
- Sponsor's protocol ID
- 202601236B0
- Other IDs
- FCRPD1P0021
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547Lim AY, Chiang CY, Lin YT, Hsu CC, Wang JS. Intelligent circuit exercise training improves platelet mitochondrial bioenergetic efficiency in sedentary men. Eur J Appl Physiol. 2026 Apr;126(4):2161-2174. doi: 10.1007/s00421-025-06014-7. Epub 2025 Dec 4.
PubMed 41343073Mitchell GF. Arterial stiffness and hypertension. Hypertension. 2014 Jul;64(1):13-8. doi: 10.1161/HYPERTENSIONAHA.114.00921. Epub 2014 Apr 21.
PubMed 24752432Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
PubMed 20338492Jarczok MN, Weimer K, Braun C, Williams DP, Thayer JF, Gundel HO, Balint EM. Heart rate variability in the prediction of mortality: A systematic review and meta-analysis of healthy and patient populations. Neurosci Biobehav Rev. 2022 Dec;143:104907. doi: 10.1016/j.neubiorev.2022.104907. Epub 2022 Oct 13.
PubMed 36243195
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Precision Exercise Integrated Health Management: Construction of Innovative Technology and Management Models and Clinical Evidence Research in Elderly Communities.
- ClinicalTrials.gov ID
- NCT07790263
- Acronym / sponsor ID
- 202601236B0
- Conditions
- Aging, Autonomic Nervous System, Hemodynamics
- Keywords
- Aerobic exercise, Circuit training, Heart rate variability, Arterial stiffness, Blood pressure, Older adults, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study employed a two-stage design. Stage 1 used a parallel-group randomized design, with participants randomly assigned to an intervention or control group. Stage 2 was a single-group, non-randomized extension in which additional participants received the intervention without a concurrent control group, conducted to evaluate real-world program effectiveness following the completion of Stage 1.
| Arm | Type | Receives |
|---|---|---|
| Arm 1_Stage 1 - Intervention Group | Experimental | Behavioral: Smart Circuit Exercise ProgramParticipants 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) |
| Arm 2_Stage 1 - Control Group | No intervention | –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) |
| Arm 3_Stage 2 - Intervention Extension (Single-Group) | Experimental | Behavioral: Smart Circuit Exercise ProgramFollowing 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) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Circuit Exercise ProgramA 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. | Behavioural | Arm 1_Stage 1 - Intervention Group, Arm 3_Stage 2 - Intervention Extension (Single-Group) |
Primary outcome
Change in Time-Domain Heart Rate Variability
Time frame: 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.
Change in Frequency-Domain Heart Rate Variability
Time frame: 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.
Change in Dynamic Heart Rate Variability Reactivity
Time frame: 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.
Change in Blood Pressure
Time frame: 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.
Change in Rate-Pressure Product
Time frame: Baseline and up to 12 weeks
Cardiac load index calculated as heart rate multiplied by systolic blood pressure, reported in bpm·mmHg.
16 secondary outcomes
Change in Skeletal Muscle Mass and Body Fat Mass
Time frame: Baseline and up to 12 weeks
Change in Percent Body Fat
Time frame: Baseline and up to 12 weeks
Change in Body Mass Index
Time frame: Baseline and up to 12 weeks
Change in Waist-Hip Ratio
Time frame: Baseline and up to 12 weeks
Change in Visceral Fat Area
Time frame: Baseline and up to 12 weeks
Change in Digital Volume Pulse Stiffness Index
Time frame: Baseline and up to 12 weeks
Change in Digital Volume Pulse Contour Reflection Index
Time frame: Baseline and up to 12 weeks
Change in Second-Derivative Photoplethysmogram Amplitude Ratios
Time frame: Baseline and up to 12 weeks
Change in Augmentation Index
Time frame: Baseline and up to 12 weeks
Change in Aging Index
Time frame: Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Muscular Strength
Time frame: Baseline and up to 12 weeks
Change in Lower- and Upper-Limb Flexibility
Time frame: Baseline and up to 12 weeks
Change in Cardiorespiratory Endurance
Time frame: Baseline and up to 12 weeks
Change in Dynamic and Static Balance
Time frame: Baseline and up to 12 weeks
Change in HbA1c
Time frame: Baseline and up to 12 months following study completion
Change in Lipid Profile
Time frame: Baseline and up to 12 months following study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 10474547Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
- Background: PubMed 41343073Lim AY, Chiang CY, Lin YT, Hsu CC, Wang JS. Intelligent circuit exercise training improves platelet mitochondrial bioenergetic efficiency in sedentary men. Eur J Appl Physiol. 2026 Apr;126(4):2161-2174. doi: 10.1007/s00421-025-06014-7. Epub 2025 Dec 4.
- Background: PubMed 24752432Mitchell GF. Arterial stiffness and hypertension. Hypertension. 2014 Jul;64(1):13-8. doi: 10.1161/HYPERTENSIONAHA.114.00921. Epub 2014 Apr 21.
- Background: PubMed 20338492Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
- Background: PubMed 36243195Jarczok MN, Weimer K, Braun C, Williams DP, Thayer JF, Gundel HO, Balint EM. Heart rate variability in the prediction of mortality: A systematic review and meta-analysis of healthy and patient populations. Neurosci Biobehav Rev. 2022 Dec;143:104907. doi: 10.1016/j.neubiorev.2022.104907. Epub 2022 Oct 13.
- Individual participant dataSharing planned: Yes. 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.
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Plant-based Diet in Older People: What Consequences for Muscle Health?
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Shyan WANG, Ph.D. principal investigator
Chang Gung University, Guishan, Taoyuan 333
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Circuit Exercise Program in people with Aging and Autonomic Nervous System, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time-Domain Heart Rate Variability (time frame: Baseline and up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07790263, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.