UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034679 |
|---|---|
| Receipt number | 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 | 2025/02/26 17:11:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Yoriko |
| Middle name | |
| Last name | Tajima |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Physical Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
physical@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Kondou |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Physical Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
physical@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
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
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
30
Results
No correlation was observed between the walking distance and peak oxygen intake at any time.There was a correlation between THBI and peak oxygen intake at any time.In particular, a fairly strong correlation was observed during effort walking of 3 minutes or more.
All of the THBIs showed high reproducibility when measured twice or more.
Results date posted
| 2020 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 healthy people(15 men,15 women)
Age; 41.4+-12.0(21-59)
Height; 166.0+-9.5cm
Weight; 63.2+-12.1kg
Participant flow
All 30 participants were subjected to the intervention and included in the analysis.
Adverse events
none
Outcome measures
Total Heart Beat Index
Peak oxygen intake
Walking destance per unit time
Plan to share IPD
none
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037102
