Chang Gung University
Taoyuan, Guishan, 33371, Taiwan
NCT Number: NCT07790263
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.
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Notify Me65 year–85 year
All sexes
Interventional
Not applicable
Taoyuan, Guishan, 33371, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: Baseline and up to 12 weeks
Cardiac load index calculated as heart rate multiplied by systolic blood pressure, reported in bpm·mmHg.
Time frame: Baseline and up to 12 weeks
Skeletal muscle mass (SMM) and body fat mass (BFM), reported in kg.
Time frame: Baseline and up to 12 weeks
Percent body fat (PBF), reported as a percentage.
Time frame: Baseline and up to 12 weeks
Body mass index (BMI), calculated from body composition analysis, reported in kg/m^2.
Time frame: Baseline and up to 12 weeks
Waist-hip ratio (WHR), reported as a ratio.
Time frame: Baseline and up to 12 weeks
Visceral fat area (VFA), reported in cm^2.
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.
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.
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.
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.
Time frame: Baseline and up to 12 weeks
Aging Index (AGI), derived from second-derivative photoplethysmogram (SDPTG) analysis, reported in arbitrary units.
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.
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.
Time frame: Baseline and up to 12 weeks
Cardiorespiratory endurance assessed using a 2-minute step test, reported in number of steps.
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.
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.
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.
Chang Gung Memorial Hospital
Other
Intelligent Precision Exercise Integrated Health Management: Construction of Innovative Technology and Management Models and Clinical Evidence Research in Elderly Communities.
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