Skip to main content
OpenTrials
Completed

NCT Number: NCT07790263

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, Guishan, 33371, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Circuit Exercise Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Change in Skeletal Muscle Mass and Body Fat Mass

    Time frame: Baseline and up to 12 weeks

    Skeletal muscle mass (SMM) and body fat mass (BFM), reported in kg.

  2. Change in Percent Body Fat

    Time frame: Baseline and up to 12 weeks

    Percent body fat (PBF), reported as a percentage.

  3. Change in Body Mass Index

    Time frame: Baseline and up to 12 weeks

    Body mass index (BMI), calculated from body composition analysis, reported in kg/m^2.

  4. Change in Waist-Hip Ratio

    Time frame: Baseline and up to 12 weeks

    Waist-hip ratio (WHR), reported as a ratio.

  5. Change in Visceral Fat Area

    Time frame: Baseline and up to 12 weeks

    Visceral fat area (VFA), reported in cm^2.

  6. Change in Digital Volume Pulse Stiffness Index

    Time frame: Baseline and up to 12 weeks

    Stiffness Index (SI), derived from photoplethysmography-based digital volume pulse (DVP) pulse contour analysis, reported in m/s.

  7. Change in Digital Volume Pulse Contour Reflection Index

    Time frame: 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.

  8. Change in Second-Derivative Photoplethysmogram Amplitude Ratios

    Time frame: 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.

  9. Change in Augmentation Index

    Time frame: 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.

  10. Change in Aging Index

    Time frame: Baseline and up to 12 weeks

    Aging Index (AGI), derived from second-derivative photoplethysmogram (SDPTG) analysis, reported in arbitrary units.

  11. Change in Lower- and Upper-Limb Muscular Strength

    Time frame: 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.

  12. Change in Lower- and Upper-Limb Flexibility

    Time frame: 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.

  13. Change in Cardiorespiratory Endurance

    Time frame: Baseline and up to 12 weeks

    Cardiorespiratory endurance assessed using a 2-minute step test, reported in number of steps.

  14. Change in Dynamic and Static Balance

    Time frame: 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.

  15. Change in HbA1c

    Time frame: 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.

  16. Change in Lipid Profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.