UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037167 |
|---|---|
| Receipt number | R000042349 |
| Scientific Title | Examination of exercise tolerability evaluation for elderly people that can be measured in a short time |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2025/02/28 16:34:37 |
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Basic information
Public title
Examination of exercise tolerability evaluation for elderly people that can be measured in a short time
Acronym
Examination of exercise tolerability evaluation for elderly people that can be measured in a short time
Scientific Title
Examination of exercise tolerability evaluation for elderly people that can be measured in a short time
Scientific Title:Acronym
Examination of exercise tolerability evaluation for elderly people that can be measured in a short time
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Rehabilitation medicine |
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, gait speed
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, gait speed, THBI and walking distance per unit time are measured after walking on the flat ground.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who can walk on the treadmill
Those who agreed to participate in this study in writing of their own free will fully understanding the content after our explanation
Key exclusion criteria
Those who fall under contraindications of cardiopulmonary exercise test
Those who are subject to any heart rate change during examination, for example those who received pacemaker insertion; those who are under beta-blocker medication; those who have atrial fibrillation, etc.
Those who are judged to have autonomic nervous abnormality
Those who have cardiovascular disease or respiratory disease that causes movement disorder
Those who have difficulty walking continuously due to pain
Those who are determined to be unsuited to participate in the study due to 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
4678622
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 | Yoriko |
| Middle name | |
| Last name | Tajima |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Physical Therapy
Zip code
4678622
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
| 2019 | Year | 06 | Month | 25 | 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
20
Results
Regarding THBI, although THBI during effort walking showed no correlation with peak VO2 only at the 2-minute time point, peak VO2 was quite correlated with THBI during other effort walking and THBI during comfortable walking.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were 10 males and 10 females, age 73.7 +- 5.8 years, height 158.4 +- 7.3 cm, and weight 58.4 +- 9.1 kg.
Participant flow
Of the 20 patients who completed the cardiopulmonary exercise stress test, 14 patients had reached their target heart rate, 3 patients had lower extremity delay, and 3 patients had lower extremity fatigue.
Adverse events
none
Outcome measures
Normality was confirmed for comfortable walking distance and effort walking distance, but not for THBI during comfortable walking and THBI during effort walking. Regarding the within-subject evaluation reproducibility of the normality-confirmed comfort walking distance and effort walking distance, the intraclass correlation coefficient ICC(1,1) had a lower limit of the 95% confidence interval of 0.7 or higher. Therefore, the first measurement was adopted for comfortable walking distance and effort walking distance, and the average of the twice-measured values was adopted for THBI during comfortable walking and effort walking.
Regarding the correlation coefficient between peak VO2 and each item, a significant correlation was found for the comfortable walking distance with p<0.05 (r=0.452-0.456) up to 3 minutes, but no significant correlation was found with p>=0.05 (r=0.419-0.440) after 4 minutes. No correlation was found for either effort walking distance at p>=0.05 (r=0.281-0.352). THBI during comfortable walking showed a significant correlation at p<0.05 (r = -0.653 to -0.614). THBI during effort walking showed a significant correlation with p>=0.05 (r=0.431) only at the 2-minute time point and p<0.05 (r=-0.466 to -0.594) at the other time points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042349
