UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061890 |
|---|---|
| Receipt number | R000070814 |
| Scientific Title | An Exploratory Intervention Study of a Group Exercise Program Using the Lumbar Type Hybrid Assistive Limb (HAL) for Community-Dwelling Older Adults: Effects on Physical Function, Feasibility and Acceptability |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/12 16:43:04 |
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Basic information
Public title
Exploratory Intervention Study of a Group Exercise Program Using the Hybrid Assistive Limb (HAL) for Community-Dwelling Older Adults: Focusing on Individuals at Risk of Frailty and Mild Cognitive Impairment
Acronym
Community HAL-FRAIL Study
Scientific Title
An Exploratory Intervention Study of a Group Exercise Program Using the Lumbar Type Hybrid Assistive Limb (HAL) for Community-Dwelling Older Adults: Effects on Physical Function, Feasibility and Acceptability
Scientific Title:Acronym
HAL-FCI
Region
| Japan |
Condition
Condition
Community-dwelling older adults at risk of frailty, mild cognitive impairment, or physical function decline
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory intervention study aims to examine the effects of a group exercise program using the lumbar type Hybrid Assistive Limb (HAL) in community-dwelling older adults at risk of frailty, mild cognitive impairment, or physical function decline. Physical function, health-related outcomes, and cognitive function will be assessed before and after the intervention, while Cyvis100 and accelerometer-based measurements will be used to monitor physical activity during the program.
Basic objectives2
Others
Basic objectives -Others
In addition to exploring potential improvements in physical function, this study will evaluate the feasibility, safety, and acceptability of a HAL-based group exercise program for community-dwelling older adults. Preliminary evidence regarding potential effects on cognitive function will also be collected.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Secondary outcomes include 10-meter walk test, hand grip strength, Locomo 25, WHO-5 Well-Being Index, cognitive function assessment, accelerometer- and Cyvis100-derived measures, satisfaction, willingness to continue, and adverse events.
Key secondary outcomes
Secondary outcomes include the 10-meter walk test, hand grip strength, Locomo 25 questionnaire, WHO-5 Well-Being Index, cognitive function assessments (Five-Cog and cognitive assessments conducted as part of the community screening program), accelerometer-derived physical activity and postural sway measures, physiological data obtained from Cyvis100, participant satisfaction, willingness to continue the program, and adverse events. Cognitive function will be evaluated as an exploratory outcome.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Participants will perform a group exercise program while wearing the lumbar-type Hybrid Assistive Limb (HAL). The program will be conducted once weekly for 10 sessions (8 exercise sessions) and will include stretching, sit-to-stand exercises, balance training, and stepping/walking exercises.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Community-dwelling older adults who participated in a community health assessment program conducted by Ami Town, Japan.
2.Individuals identified as being at risk of frailty, mild cognitive impairment, or physical function decline based on assessment results.
3.Aged 60 to 90 years at enrollment.
4.Able to participate in a group exercise program.
5.Able to understand the study procedures and provide written informed consent.
Key exclusion criteria
1.Individuals prohibited from exercise by their physician.
2.Individuals with severe cardiovascular, respiratory, neurological, or musculoskeletal conditions that would make participation unsafe.
3.Individuals who experienced myocardial infarction, stroke, fracture, surgery, or other major medical events within the previous three months.
4.Individuals with severe balance impairment or frequent falls that would make safe participation difficult.
5.Individuals unable to wear the HAL device or assessment equipment.
6.Individuals unable to understand the study procedures or provide valid informed consent.
7.Any other individual judged unsuitable by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Omiya |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Health Science, Department of Public Health Nursing
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
09097130834
toomiya@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Omiya |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Health Science, Department of Public Health Nursing
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
09097130834
Homepage URL
toomiya@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ibaraki Prefectural University of Health Sciences
R Professional University of Rehabilitation Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070814
