UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060359 |
|---|---|
| Receipt number | R000069040 |
| Scientific Title | Dissociation between muscle mass and strength following a community based voluntary frailty prevention exercise intervention in community dwelling older adults living in a resource limited rural area: a non-randomized longitudinal pilot study (The Ainan Study) |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/14 23:53:28 |
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Basic information
Public title
Community based voluntary frailty prevention exercise in older adults living in a resource limited rural area: a 6 month non-randomized longitudinal pilot study (The Ainan Study)
Acronym
AINAN Frailty Exercise Pilot
Scientific Title
Dissociation between muscle mass and strength following a community based voluntary frailty prevention exercise intervention in community dwelling older adults living in a resource limited rural area: a non-randomized longitudinal pilot study (The Ainan Study)
Scientific Title:Acronym
AINAN Muscle Mass Strength Pilot
Region
| Japan |
Condition
Condition
Frailty in community dwelling older adults
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of a community based voluntary frailty prevention exercise intervention on muscle strength, physical function, and body composition over 6 months in community dwelling older adults living in a resource limited rural area. The primary objective is to assess the change in muscle strength as measured by grip strength from baseline to 6 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in muscle strength as measured by grip strength from baseline to 6 months.
Key secondary outcomes
To explore the association between changes in muscle mass and changes in muscle strength.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group (n=8) participated in a 6-month community-based voluntary multicomponent frailty prevention exercise program jointly developed by physical and occupational therapists. The program was primarily self-managed and incorporated into participants' daily routines at home and in the community. The program consisted of seven exercise components: (1) stretching; (2) low-intensity resistance training using 500g water bottles; (3) dual-task exercises; (4) sit-to-stand movements; (5) balance training; (6) stair climbing; and (7) hill walking.
Interventions/Control_2
The control group (non-intervention group; n=6) continued their usual daily activities during the study period and received no structured exercise program as part of the study.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants were community-dwelling older adults who met all of the following criteria:
(1) Aged 65 years or older and residing in Ainan Town, Minamiuwa District, Ehime Prefecture, Japan (both sexes eligible).
(2) Able to understand the study procedures and provide written informed consent personally.
(3) Not prohibited from exercising by a physician and judged medically safe to participate in exercise.
(4) No physician-diagnosed dementia.
Eligibility was confirmed through an interview and medical history taking.
Key exclusion criteria
Participants were excluded if they met any of the following criteria:
(1) Medical contraindication to exercise or physician-imposed restrictions on exercise.
(2) Severe cardiovascular, respiratory, or musculoskeletal disease (or other serious conditions) that would preclude safe participation and/or completion of assessments.
(3) Difficulty understanding the study procedures or providing informed consent (including inability to provide written consent due to dementia or related conditions).
(4) Judged unlikely to be able to complete the primary outcome assessments.
(5) Any other condition for which the principal investigator determined that continued participation would be inappropriate due to safety concerns or feasibility of study conduct.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Watanabe |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
990-2212
Address
Yamagata Prefecture, Yamagata City, Kamiyanagi 260
TEL
023-686-6611
jwatanabe@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Ichibukata |
Organization
Ehime Prefectural Minamiuwa Hospital
Division name
Rehabilitation Department
Zip code
798-4131
Address
2433-1 Johen-ko, Ainan-cho, Minamiuwa-gun, Ehime Prefecture
TEL
0895-72-1231
Homepage URL
ichibukata_yosuke@eph.pref.ehime.jp
Sponsor or person
Institute
Ehime Prefectural Minamiuwa Hospital
Institute
Department
Personal name
Yosuke Ichibukata
Funding Source
Organization
Yamagata Prefectural University of Health Sciences
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
Ehime Prefectural Minamiuwa Hospital Ethics Committee
Address
2433-1 Johen-ko, Ainan-cho, Minamiuwa-gun, Ehime Prefecture
Tel
0895-72-1231
ichibukata_yosuke@eph.pref.ehime.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
愛媛県立南宇和病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | 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
14
Results
In an exploratory 6-month pilot (intervention n=8, non-intervention n=6) using linear mixed-effects models, significant group-by-time interactions indicated decreases in BMR (1225.1->1208.4 kcal/day, p<0.001), SMI (6.28->6.15 kg/m2, p=0.016) and SMM (21.14->20.79 kg, p<0.001), while grip strength was maintained (p=0.736).
Results date posted
| 2026 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 14 community-dwelling older adults (intervention n=8, non-intervention n=6). Mean age was 76.6+/-6.8 years (range 67-96). There were 10/14 females (71.4%) and 4/14 males (28.6%).
Participant flow
Twenty-three community-dwelling older adults participated in the first physical fitness assessment. Of these, 14 participants also attended the second assessment approximately 6 months later and were included in the longitudinal analysis. Participants self-selected into study groups: 8 in the intervention group and 6 in the non-intervention group. Major outcomes were assessed at baseline (Pre) and at 6 months (Post).
Adverse events
No adverse events related to the intervention were observed during the study period. No serious incidents or injuries occurred during assessments or exercise participation.
Outcome measures
Primary outcome measures were Timed Up and Go (TUG), grip strength, skeletal muscle mass (SMM), skeletal muscle index (SMI), basal metabolic rate (BMR), and one-leg stance time.
Secondary outcome measure was weekly sitting time (min/week).
Outcomes were assessed at baseline (Pre) and at approximately 6 months (Post).
Plan to share IPD
Individual participant data (IPD) will not be shared.
IPD sharing Plan description
Individual participant data will not be shared Aggregate results will be disseminated through conference presentations and publications
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 16 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069040
