UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054361 |
|---|---|
| Receipt number | R000062094 |
| Scientific Title | Behavioral change investigation after recognition for osteoporosis and frailty in working women aged 40-64 at Hospital A |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2024/12/06 11:38:46 |
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Basic information
Public title
Behavioral change investigation after recognition for osteoporosis and frailty in working women aged 40-64 at Hospital A
Acronym
Osteoporosis survey targeting women aged 40-64 at Hospital A
Scientific Title
Behavioral change investigation after recognition for osteoporosis and frailty in working women aged 40-64 at Hospital A
Scientific Title:Acronym
Osteoporosis survey targeting women aged 40-64 at Hospital A
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether awareness for osteoporosis and frailty among working women aged 40 to 64 at Hospital A is useful in changing health behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the following items after the first time and 6 months later.
(1)Calcium intake status
Key secondary outcomes
To investigate the following items after the first time and 6 months later.
(1)Exercise habits (2)Young Adult Mean(bone density) (3)Skeletal Muscle Mass Index (4)Walking speed (5)Grip strength (6)Progression of physical frailty(Japanese Cardiovascular Health Study Standards)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
(1) Questionnaire survey: Eating habits(calcium intake status), exercise habits, physical frailty symptoms
(2) Measurement survey: bone density, body composition, grip strength, walking speed
Health guidance is done based on the results of the survey mentioned above, and re- examination will be carried out 6 months later.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Working women aged 40-64 at Hospital A
(2)Those who have consented to the current research by signing a consent form
Key exclusion criteria
(1)Exclude medical electrical equipment users due to the use of multi-frequency body composition monitors
(2)Those who do not agree with the purpose of the current research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Narita |
Organization
Akita Rosai Hospital, Independent Administrative Agency, Workers Health and Safety Organization
Division name
nursing department
Zip code
018-5604
Address
30 Shimodai, Karuizawa, Odate City, Akita Prefecture
TEL
0186523131
kangofukubucho@akitah.johas.go.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Narita |
Organization
Akita Rosai Hospital, Independent Administrative Agency, Workers Health and Safety Organization
Division name
nursing department
Zip code
018-5604
Address
30 Shimodai, Karuizawa, Odate City, Akita Prefecture
TEL
0186523131
Homepage URL
kangofukubucho@akitah.johas.go.jp
Sponsor or person
Institute
Akita Rosai Hospital, Independent Administrative Agency, Workers Health and Safety Organization
Institute
Department
Personal name
Kumiko Narita
Funding Source
Organization
Japan Labor Health and Safety Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Administrative Agency Japan Labor Health and Safety Organization, Akita Rosai Hospital Ethics Committee
Address
30 Shimodai, Karuizawa, Odate City, Akita Prefecture
Tel
0186523131
info@akitah.johas.go.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
| 2024 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://procomu.jp/jsomt72/
Number of participants that the trial has enrolled
55
Results
Comparing the initial outcomes with those after 6 months, dietary habits (calcium intake status) scores improved significantly after 6 months in both the 40~49 and 50 ~ 64 -year-old group. As for exercise habits, the number of the exercising participants decreased in 40~49-year-old group after 6 months, On contrast, the number of exercising participants increased in 50~64-year-old group.
Results date posted
| 2024 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty-five working women with the average age was 50.9 years old in Hospital A. The average body height and body weight were 158.1cm and 57.5kg.
Participant flow
Informed consent to participate in the current study was obtained from the working women aged 40 to 64 years old in Hospital. Seventy-two women underwent the initial measurements, of which 55 underwent the same measurement 6 months later. The final participants enrolled for the current study were 55 women underwent the both measurements.
Adverse events
Loss of bone density observed in whole participants
Outcome measures
1.Dietary habits
The average score on the calcium self-check sheet was 9.0 points initially, and 10.2points 6 months later. A significant improvement was found (p=0.002). As for the age group, the scores improved significantly 6 months later in 40~49 and 50~64 -year-old groups (p=0.0064, p=0.0391).
2. Exercise habits
Overall, 20.0% (11/55) of participants with exercise habit initially, and 23.6% (13/55) after 6 months.
Regarding the age group, the percentage of the participants with exercise habits was 7.7% (2/26) initially and 3.8% (1/26) at 6 months later in 40~49-year-old group. The percentage was 31.0% (9/29) initially and 41.4% (12/29) 6 months later in 50~64-year-old group. A significant increase of the percentage with exercise habits was found in 50~64 -year-old group. (p=0.0031).
3. Young Adult Mean of Bone Density
In 40~49-year-old group, it was 89.9% initially ,and 88.0% 6 months later. In 50~64 years old group, it was 84.4% initially, and 80.2% 6 months later. Both in the initial and the value 6 months later, significant differences were observed between 40~49 and 50~64-year-old group both in (p=0.0394,p=0.004),respectively. Furthermore, the YAM value was significantly lower 6 months later than that of the initialin 50~64-year-old group (p=0.0037).
4. SMI (Appendicular Skeletal Muscle Mass Index) values
In 40~49-year-old group, it was 6.9kg/m2, and 6.8kg/m2 6 months later. In 50~64-year-old group, the initial value was 6.8kg/m2, and 6.8kg/m2 6 months later. In both groups, no significant change was observed between the initial and the value at 6 months later.
5. "Walking speed" (time to walk 5 m)
In 40~49-year-old group, it was 3.5 seconds initially, and 3.4 seconds 6 months later. In 50~64-year-old group, it was 3.3 seconds, and 3.3 seconds 6 months later. In both groups, no significant change was observed between the initial and the value at 6 months later.
6. Grip strength
In 40~49-year-old group, grip strength was 27.5kg initially, and 27.3kg 6 months later. In 50~64-year-oldgroup, grip strength was 26.5kg initially, and 26.1kg 6 months later. In both groups, no significant change was observed between the initial and the value 6 months later.
7. Prevalence of physical frailty
Initially, the percentage of the frail, the pre-frail, and the healthy participants were 5.5% (3/55), 67.3% (37/55), and 27.3% (15/55), respectively. Six months later, the percentage of the frail, the pre-frail, and the healthy participants were 0% (0/55), 74.5% (41/55), and 25.5% (14/55), respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062094
