NCT07790263

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

August 20, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

Aerobic exerciseCircuit trainingHeart rate variabilityArterial stiffnessBlood pressureOlder adultsDigital health

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and up to 12 weeks

Secondary Outcomes (16)

  • Change in Skeletal Muscle Mass and Body Fat Mass

    Baseline and up to 12 weeks

  • Change in Percent Body Fat

    Baseline and up to 12 weeks

  • Change in Body Mass Index

    Baseline and up to 12 weeks

  • Change in Waist-Hip Ratio

    Baseline and up to 12 weeks

  • Change in Visceral Fat Area

    Baseline and up to 12 weeks

  • +11 more secondary outcomes

Study Arms (3)

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)

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)

Behavioral: Smart Circuit Exercise Program

Interventions

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.

Arm 1_Stage 1 - Intervention GroupArm 3_Stage 2 - Intervention Extension (Single-Group)

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan, Guishan, 33371, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 10474547BACKGROUND
  • 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.

    PMID: 41343073BACKGROUND
  • Mitchell GF. Arterial stiffness and hypertension. Hypertension. 2014 Jul;64(1):13-8. doi: 10.1161/HYPERTENSIONAHA.114.00921. Epub 2014 Apr 21.

    PMID: 24752432BACKGROUND
  • 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.

    PMID: 20338492BACKGROUND
  • 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.

    PMID: 36243195BACKGROUND

Study Officials

  • Jong-Shyan WANG, Ph.D.

    Chang Gung University, Guishan, Taoyuan 333

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the exercise intervention, participants and intervention personnel could not be blinded to group assignment. Outcome assessors were not blinded to group allocation during data collection.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 27, 2026

Study Start

May 10, 2024

Primary Completion

February 27, 2026

Study Completion

February 28, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning after publication, with no defined end date, upon reasonable request.
Access Criteria
Requests will be reviewed by the corresponding author and require institutional/ethics approval where applicable.

Locations