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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034679
Receipt No. R000037102
Scientific Title Examination of exercise tolerability evaluation that can be measured in a short time.
Date of disclosure of the study information 2018/10/29
Last modified on 2019/02/27

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Basic information
Public title Examination of exercise tolerability evaluation that can be measured in a short time.
Acronym Examination of exercise tolerability evaluation that can be measured in a short time.
Scientific Title Examination of exercise tolerability evaluation that can be measured in a short time.
Scientific Title:Acronym Examination of exercise tolerability evaluation that can be measured in a short time.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Cardiology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the index of exercise tolerability evaluation that can be measured in a short time.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Total Heart Beat Index
Key secondary outcomes Peak oxygen intake, walking distance per unit time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 All subjects perform a cardiopulmonary exercise test using a treadmill, and subsequently measure the peak oxygen intake. Furthermore, after walking on the flat ground for 6 minutes, THBI and walking distance per unit time are measured.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults
Those with consent
Key exclusion criteria Those who have any cardiovascular, or respiratory disorders
Those who cannot walk about 10 minutes at a stretch
Those who are determined to be unsuited to participate in the study due to the other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoriko Tajima
Organization Nagoya City Rehabilitation Agency
Division name Division of Physical Therapy
Zip code
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email physical@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Kondou
Organization Nagoya City Rehabilitation Agency
Division name Division of Physical Therapy
Zip code
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email physical@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 29 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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 10 Month 29 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037102

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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