UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a new intervention program for older adults with musculoskeletal pain
Title of the study (Brief title)	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	Tatsuya Hirase
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Health Sciences
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	Tatsuya Hirase
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021418