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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024979
Receipt No. R000028711
Scientific Title Reliability and validity of the 2-minute walk test among spinal compression fracture patients
Date of disclosure of the study information 2016/11/25
Last modified on 2019/03/14

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Basic information
Public title Reliability and validity of the 2-minute walk test among spinal compression fracture patients
Acronym Reliability and validity of the 2-minute walk test
Scientific Title Reliability and validity of the 2-minute walk test among spinal compression fracture patients
Scientific Title:Acronym Reliability and validity of the 2-minute walk test
Region
Japan

Condition
Condition spinal compression fracture
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to examine the reliability and validity of the 2-minutes walk test among spinal compression fracture patients.
Basic objectives2 Others
Basic objectives -Others The purpose of this study was to examine the reliability and validity of the 2-minutes walk test among spinal compression fracture patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-minute walking test
Key secondary outcomes >6-minute walking test
>HR
>Rating of Perceived Exertion scores for dyspnea and leg fatigue
>SpO2

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants included in the study had a spinal compression fracture at the thoracic, thoracolumbar or lumbar spine level. Inclusion criteria for participants were that they be 70 years of age or older, Japanese speaking, and able to ambulate at least 6 minutes without physical assistance from another person.
Key exclusion criteria Participants were excluded from the study if they were unable to provide informed consent due to cognitive impairment, or if they had a history of disorder that neuromuscular disorder or cerebrovascular disease.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Goda
Organization Jyuzen Memorial Hosipital
Division name Rehabilitation Center
Zip code 434-0041
Address 1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
TEL +81-53-586-1115
Email 12dr02@g.seirei.ac.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Goda
Organization Jyuzen Memorial Hosipital
Division name Rehabilitation Center
Zip code 434-0041
Address 1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
TEL +81-53-586-1115
Homepage URL
Email 12dr02@g.seirei.ac.jp

Sponsor
Institute Jyuzen Memorial Hosipital
Institute
Department

Funding Source
Organization Self funding
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 Jyuzen Memorial Hosipital
Address 1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
Tel +81-53-586-1115
Email 12dr02@g.seirei.ac.jp

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
2016 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 03 Month 11 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 16 Day
Date of IRB
2016 Year 11 Month 23 Day
Anticipated trial start date
2016 Year 11 Month 24 Day
Last follow-up date
2016 Year 12 Month 10 Day
Date of closure to data entry
2016 Year 12 Month 29 Day
Date trial data considered complete
2016 Year 12 Month 29 Day
Date analysis concluded
2017 Year 01 Month 04 Day

Other
Other related information Reliability and validity of the 2-minutes walk test among spinal compression fracture patients

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028711

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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