Frail Older AdultsNCT07698912
The Effects of an AIoT-Based Exercise System on Frail Older Adults
A study testing AIoT-based Feedback Assistive Strengthening Ergometer in people with Frail Older Adults, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Older Adults
- What is being tested?
- AIoT-based Feedback Assistive Strengthening Ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult over 65 years old
- The Clinical Frailty Scale (CFS) score of 3 to 7 (hospitalized patients)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AIoT-Based Ergometer for Early Rehabilitation in Geriatric Wards: Supporting Physical Recovery in Frail Older Adult
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.
Read the detailed description
At baseline, participants will undergo a personal health assessment and physical fitness evaluation. The personal health assessment includes collection of demographic information, past medical history, general health status, and clinical frailty scale. Physical fitness assessment consists of handgrip strength, Timed Up and Go test and 4-meter walk test. These baseline assessments will be used to individualize and guide the AIFASE exercise program.
Following the baseline assessment, the intervention group will undergo training using an AIFASE exercise system. Muscle strength of the major muscle groups in the upper and lower extremities (elbow flexors, elbow extensors, knee flexors, and knee extensors) will be evaluated at both baseline and post-intervention.
During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously recorded in real time.
- Conditions
- Frail Older Adults
- Being tested
- AIoT-based Feedback Assistive Strengthening Ergometer
- Keywords
- Seniors, Frailty, Exercise, AI
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIoT-based Feedback Assistive Strengthening ErgometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Frail older adults | Experimental | Participants will undergo AIoT-based feedback assistive strengthening ergometer exercise program. Receives: Device: AIoT-based Feedback Assistive Strengthening Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of knee extensors
Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.
Measured: baseline
Muscle strength of knee extensors
Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.
Measured: through study completion, an average of 13 days
Secondary outcomes (15)
Timed Up and Go test (TUG)
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Measured: basline
Gait speed (4-meter walk test)
To measure the gait speed when participants walk across the test zone (4 meter).
Measured: baseline
Clinical Frailty Scale (CFS)
Clinical Frailty Scale (CFS), a validated 9-point instrument in which a score of 1 indicates very fit status and a score of 9 indicates terminal illness.
Measured: baseline
Short Portable Mental Status Questionnaire (SPMSQ)
The questionnaire is a brief 10-item clinical tool to quickly assess cognitive impairment in older adults. It evaluates short- and long-term memory, orientation, information about current events, and mathematical capacity.
Measured: baseline
Geriatric Depression Scale (GDS-5)
The survey is a brief 5 questions to quickly assess depression, with scores ≥2 indicating possible depressive disorder in older adults.
Measured: baseline
Activities of Daily Living (ADLs)
The ability to maintain daily living is evaluated by personal hygiene, dressing, eating, toileting, and mobility.
Measured: baseline
Activities of Daily Living (ADLs)
The ability to maintain daily living is evaluated by personal hygiene, dressing, eating, toileting, and mobility.
Measured: through study completion, an average of 13 days
EQ-5D (EuroQol- 5 Dimensions)
EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status. EQ-5D was first introduced in 1990 by the EuroQol Group. In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).
Measured: baseline
Mini Nutritional Assessment-Short Form (MNA-SF)
The nutritional status is evaluated by food intake, weight loss, mobility, stress, neuropsychology, and mobility. The scores less than 7 indicated malnutrition.
Measured: baseline
Muscle strength of elbow flexors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: baseline
Muscle strength of elbow flexors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: through study completion, an average of 13 days
Muscle strength of elbow extensors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: baseline
Muscle strength of elbow extensors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: through study completion, an average of 13 days
Muscle strength of knee flexors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: baseline
Muscle strength of knee flexors
Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.
Measured: through study completion, an average of 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 May 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Ming Chang, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698912
- Sponsor's protocol ID
- A-ER-109-063
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIoT-Based Ergometer for Early Rehabilitation in Geriatric Wards: Supporting Physical Recovery in Frail Older Adult
- ClinicalTrials.gov ID
- NCT07698912
- Acronym / sponsor ID
- A-ER-109-063
- Conditions
- Frail Older Adults
- Keywords
- Seniors, Frailty, Exercise, AI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At baseline, participants will undergo a personal health assessment and physical fitness evaluation. The personal health assessment includes collection of demographic information, past medical history, general health status, and clinical frailty scale. Physical fitness assessment consists of handgrip strength, Timed Up and Go test and 4-meter walk test. These baseline assessments will be used to individualize and guide the AIFASE exercise program.
Following the baseline assessment, the intervention group will undergo training using an AIFASE exercise system. Muscle strength of the major muscle groups in the upper and lower extremities (elbow flexors, elbow extensors, knee flexors, and knee extensors) will be evaluated at both baseline and post-intervention.
During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously recorded in real time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail older adults | Experimental | Device: AIoT-based Feedback Assistive Strengthening ErgometerParticipants will undergo AIoT-based feedback assistive strengthening ergometer exercise program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adult over 65 years old
- The Clinical Frailty Scale (CFS) score of 3 to 7 (hospitalized patients)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIoT-based Feedback Assistive Strengthening ErgometerThe 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. | Device | Frail older adults |
Primary outcome
Muscle strength of knee extensors
Time frame: baseline
Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.
Muscle strength of knee extensors
Time frame: through study completion, an average of 13 days
Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.
15 secondary outcomes
Timed Up and Go test (TUG)
Time frame: basline
Gait speed (4-meter walk test)
Time frame: baseline
Clinical Frailty Scale (CFS)
Time frame: baseline
Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: baseline
Geriatric Depression Scale (GDS-5)
Time frame: baseline
Activities of Daily Living (ADLs)
Time frame: baseline
Activities of Daily Living (ADLs)
Time frame: through study completion, an average of 13 days
EQ-5D (EuroQol- 5 Dimensions)
Time frame: baseline
Mini Nutritional Assessment-Short Form (MNA-SF)
Time frame: baseline
Muscle strength of elbow flexors
Time frame: baseline
Muscle strength of elbow flexors
Time frame: through study completion, an average of 13 days
Muscle strength of elbow extensors
Time frame: baseline
Muscle strength of elbow extensors
Time frame: through study completion, an average of 13 days
Muscle strength of knee flexors
Time frame: baseline
Muscle strength of knee flexors
Time frame: through study completion, an average of 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIoT-based Feedback Assistive Strengthening Ergometer in people with Frail Older Adults, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength of knee extensors (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.