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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031408
Receipt No. R000035862
Scientific Title Infruence on health-related quality of life of a program to improve physical activity in the elderly with postoperative pain
Date of disclosure of the study information 2018/03/01
Last modified on 2019/02/22

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Basic information
Public title Infruence on health-related quality of life of a program to improve physical activity in the elderly with postoperative pain
Acronym Effect of a program to improve physical activity in the elderly with postoperative pain
Scientific Title Infruence on health-related quality of life of a program to improve physical activity in the elderly with postoperative pain
Scientific Title:Acronym Effect of a program to improve physical activity in the elderly with postoperative pain
Region
Japan

Condition
Condition lumbar spinal stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify effect of a program to improve physical activity in the elderly with postoperative pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes health-related quality of life
Key secondary outcomes

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 increasing physical activity in daily living
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria persons who underwent lumbar surgery at least one year ago
Key exclusion criteria persons who have limitation of physical activity due to heart disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Higuchi
Organization Takasaki University of Health and Welfare
Division name Department of Physical Therapy
Zip code
Address 501 Nakaorui-machi, Takasaki-shi,Gunma, Japan
TEL 027-352-1291
Email higuchi-d@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Higuchi
Organization Takasaki University of Health and Welfare
Division name Department of Physical Therapy
Zip code
Address 501 Nakaorui-machi, Takasaki-shi,Gunma, Japan
TEL 027-352-1291
Homepage URL
Email higuchi-d@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 03 Month 01 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 Terminated
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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
2018 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035862

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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