UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031408
Receipt number 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 12:15:57

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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 or person

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name



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

Value
https://center6.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