UMIN-CTR Clinical Trial

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
Last 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
1st 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