UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018503 |
|---|---|
| Receipt number | R000021418 |
| Scientific Title | Development of a new intervention program for older adults with musculoskeletal pain |
| Date of disclosure of the study information | 2015/07/31 |
| Last modified on | 2019/02/01 09:25:33 |
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Basic information
Public title
Development of a new intervention program for older adults with musculoskeletal pain
Acronym
Effects of intervention program for older adults with musculoskeletal pain
Scientific Title
Development of a new intervention program for older adults with musculoskeletal pain
Scientific Title:Acronym
Effects of intervention program for older adults with musculoskeletal pain
Region
| Japan |
Condition
Condition
Community-dwelling older adults with musculoskeletal pain
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether combined exercise program with self-management is effective in improvements of pain, physical performance, psychological status, and physical activities for community-dwelling older adults with musculoskeletal pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of pain at 12 weeks after starting the intervention: Numerical rating scale
Key secondary outcomes
Physical performance: one-leg standing test, chair standing test, timed up and go test
Psychological status: Geriatric Depression Scale, Fall Efficacy Scale, Pain Catastrophizing Scale
Physical activity using accelerometers: step counts, low, moderate, and high intensity physical activity time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
a weekly exercise program for 12 weeks and daily self-management of the severity of pain and steps using a pedometer
Interventions/Control_2
Control group:
a weekly exercise program for 12 weeks
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
1) Independent community-dwelling older adults aged 65 years and older
2) Older adults who are high risk of requiring long-term care and participate in project for the prevention of dependence on long-term care insurance in Unzen city
3) Older adults with musculoskeletal pain
4) Being agreed with participation in the study
Key exclusion criteria
1) Older adults without musculoskeletal pain
2) Having serious or unstable illness
3) Older adults who are unable to respond to interview questions because of cognitive impairment
4) Needing long-term care
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Hirase |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Health Sciences
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
TEL
095-819-7937
htatsuya@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Hirase |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Health Sciences
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
TEL
095-819-7937
Homepage URL
htatsuya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021418
