NCT07698912

Brief Summary

This clinical trial aims to evaluate the effectiveness of an Artificial Intelligence of Things (AIoT)-based feedback assistive strengthening ergometer (AIFASE) exercise system on frail older adults in geriatric wards. Baseline assessments will include physical fitness, functional performance, and frailty severity. Muscle strength of the major muscle groups in the upper and lower extremities will be evaluated at both baseline and post-intervention. Throughout the intervention, exercise-related data, including exercise duration, workload, heart rate, rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously and simultaneously collected for analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

July 2, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

SeniorsFrailtyExerciseAI

Outcome Measures

Primary Outcomes (2)

  • Muscle strength of knee extensors

    Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

    baseline

  • Muscle strength of knee extensors

    Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

    through study completion, an average of 13 days

Secondary Outcomes (15)

  • Timed Up and Go test (TUG)

    basline

  • Gait speed (4-meter walk test)

    baseline

  • Clinical Frailty Scale (CFS)

    baseline

  • Short Portable Mental Status Questionnaire (SPMSQ)

    baseline

  • Geriatric Depression Scale (GDS-5)

    baseline

  • +10 more secondary outcomes

Study Arms (1)

Frail older adults

EXPERIMENTAL

Participants will undergo AIoT-based feedback assistive strengthening ergometer exercise program.

Device: AIoT-based Feedback Assistive Strengthening Ergometer

Interventions

The system provides individualized exercise programs based on baseline physical fitness levels and dynamically adjusts the training intensity according to physiological feedback. The system also continuously records exercise-related device data, personal physiological parameters.

Frail older adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adult over 65 years old
  • The Clinical Frailty Scale (CFS) score of 3 to 7 (hospitalized patients)

You may not qualify if:

  • Limb disability or joint deformation
  • Admission to the intensive care unit, scheduled surgery, anticipated discharge within three days, medical contraindications to physical activity, or enrollment in hospice care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 13, 2026

Study Start

May 1, 2020

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

July 13, 2026

Record last verified: 2023-07

Locations