UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059960 |
|---|---|
| Receipt number | R000068543 |
| Scientific Title | Effects of an Eight-Week Agility-Based Fall-Prevention Training Program on Intrinsic Capacity in Community-Dwelling Pre-Frail Older Adults with Mild Cognitive Impairment: A Two-Month Follow-up Randomized Clinical Trial |
| Date of disclosure of the study information | 2026/04/05 |
| Last modified on | 2025/12/01 14:01:47 |
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Basic information
Public title
Agility Training to Reduce Falls and Improve Intrinsic Capacity in Older Adults with Mild Cognitive Impairment
Acronym
AGILE-MCI Trial
Scientific Title
Effects of an Eight-Week Agility-Based Fall-Prevention Training Program on Intrinsic Capacity in Community-Dwelling Pre-Frail Older Adults with Mild Cognitive Impairment: A Two-Month Follow-up Randomized Clinical Trial
Scientific Title:Acronym
AGILE-MCI Trial: Effects of an Eight-Week Agility-Based Fall-Prevention Program on Intrinsic Capacity in Pre-Frail Older Adults with Mild Cognitive Impairment
Region
| Asia(except Japan) |
Condition
Condition
Pre-frailty and Mild Cognitive Impairment (MCI) in Community Dwelling Older Adults
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of an eight-week agility-based fall-prevention training program on motor function, cognitive function, mental health, and vitality in community-dwelling pre-frail older adults with mild cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Intrinsic Capacity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will complete an eight-week supervised agility-based fall-prevention program with three 30-45 minute sessions per week. Each session includes a warm-up, a circuit of exercises targeting balance, agility, motor function, and dual-task performance (for example, cone weaving, tandem walking, stair navigation, figure-8 walking, side-stepping, shuttle walks, and ball toss), and a cool-down. Exercises progressively increase in intensity and complexity and are tailored to individual abilities. All sessions are supervised by trained professionals, and a brief pilot phase ensures safety and feasibility before the main trial.
Interventions/Control_2
Control participants will receive no intervention during the eight-week study period and will continue their usual daily activities. To ensure equipoise and ethical compensation for participation, the control group will be offered four supervised training sessions using the same protocol after study completion.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 65 years or older, Barthel Index 60 or higher, able to communicate and walk independently, diagnosed with mild cognitive impairment or mild dementia (DSM-5), Global Deterioration Scale 3 or higher, frailty score 2 or higher (Fried), and availability of a caregiver to assist with exercises.
Key exclusion criteria
Medical contraindications to exercise (PAR-Q), severe cardiovascular, musculoskeletal, respiratory, or cerebrovascular diseases, neurodegenerative or psychiatric disorders, vestibular disorders, uncontrolled hypertension (>160/100 mmHg), or severe uncorrected visual impairment/retinal detachment.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport Scince
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport science
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
Homepage URL
ay.naderi@shahodut.ac.ir
Sponsor or person
Institute
Iran National Science Foundation
Institute
Department
Personal name
Funding Source
Organization
Iran National Science Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakim Sabzevari University
Address
Sabzevar city at Razavi Khorasan province, Iran
Tel
05144410104
h.shahrokhi@hsu.ac.ir
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 | 04 | Month | 05 | 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
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068543
