Effects of a Smart Circuit Exercise Program on Health Outcomes in Community-Dwelling Older Adults
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Guishan
-
Taoyuan, Guishan, Taiwan, 33371
- Chang Gung University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: 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)
|
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Time-Domain Heart Rate Variability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Skeletal Muscle Mass and Body Fat Mass
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jong-Shyan WANG, Ph.D., Chang Gung University, Guishan, Taoyuan 333
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Vlachopoulos 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.
- Jarczok 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.
- Lim 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.
- Mitchell GF. Arterial stiffness and hypertension. Hypertension. 2014 Jul;64(1):13-8. doi: 10.1161/HYPERTENSIONAHA.114.00921. Epub 2014 Apr 21.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 202601236B0
- FCRPD1P0021 (Annet stipend/finansieringsnummer: Wang Chang-Gung Charitable Trust Fund)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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