UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018503
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email htatsuya@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021418

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.