UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028806 |
|---|---|
| Receipt number | R000032955 |
| Scientific Title | Interrelationships among cognitive, motor and cardiorespiratory functions during motor-cognitive dual-task. -Effect of aging- |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2025/03/09 13:09:40 |
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Basic information
Public title
Interrelationships among cognitive, motor and cardiorespiratory functions during motor-cognitive dual-task. -Effect of aging-
Acronym
Motor-cognitive dual-task interference
Scientific Title
Interrelationships among cognitive, motor and cardiorespiratory functions during motor-cognitive dual-task. -Effect of aging-
Scientific Title:Acronym
Motor-cognitive dual-task interference
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the effect of change of difficulty or type of one task on each task performance and cardiorespiratory responses during motor-cognitive dual-task.
Furthermore, we also aim to clear the effects of aging and the level of cognitive functions on these dual-task performances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Accuracy of pedaling rate and performance of cognitive function tests (e.g. response time, error rate).
Key secondary outcomes
Respiratory response (e.g. ventilation, breathing frequency, oxygen uptake) and circulatory response (e.g. heart rate, blood pressure) during dual-task.
The relationships between aging and the level of cognitive functions and the dual-task performances.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The young participants pedal bicycle ergometers at their preferred cadences and 7.5rpm faster or slower than preferred cadences for 5 min each in the random order. Exercise intensity is adjusted to participants' 40% heart rate reserve (HRR). The participants simultaneously perform cognitive task at the last 3 min of each condition (dual-task). The changes of each dual-task performance by different motor tasks are compared with single motor or cognitive task performances.
Interventions/Control_2
The elderly participants pedal bicycle ergometers at their preferred cadences and 6rpm faster or slower than preferred cadences for 5 min each in the random order. Exercise intensity is adjusted to participants' 40% heart rate reserve (HRR). The participants simultaneously perform cognitive task at the last 3 min of each condition (dual-task). The changes of each dual-task performance by different motor tasks are compared with single motor or cognitive task performances.
Interventions/Control_3
The young participants pedal bicycle ergometers at 7.5rpm faster than their preferred cadences with 40%HRR for 4 min. The participants perform a cognitive task simultaneously at the last 2 min (dual-task). The cognitive tasks consist of 2 different cognitive tests with 2 different difficulties and 1 different cognitive task, total 5 conditions. The changes of each dual-task performance by different cognitive tasks are compared with single motor or cognitive task performances.
Interventions/Control_4
The elderly participants pedal bicycle ergometers at 6rpm faster than their preferred cadences with 40%HRR for 4 min. The participants perform a cognitive task simultaneously at the last 2 min (dual-task). The cognitive tasks consist of 2 different cognitive tests with 2 different difficulties and 1 different cognitive task, total 5 conditions. The changes of each dual-task performance by different cognitive tasks are compared with single motor or cognitive task performances.
Interventions/Control_5
The young participants perform single cognitive, single motor (ergometer exercise with 40%HRR, preferred cadences) and dual motor-cognitive tasks for 3 min from rest. Ventilatory (minute ventilation, respiratory frequency) and circulatory (heart rate, blood pressure) responses to these tasks from rest evaluated by gain and time constant are compared among 3 tasks.
Interventions/Control_6
The elderly participants perform single cognitive, single motor (ergometer exercise with 40%HRR, preferred cadences) and dual motor-cognitive tasks for 3 min from rest. Ventilatory (minute ventilation, respiratory frequency) and circulatory (heart rate, blood pressure) responses to these tasks from rest evaluated by gain and time constant are compared among 3 tasks.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Patients who are prohibited to do exercise completely
Patients who are prohibited to do vigorous exercise
Dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furo-cho, Chikusa-ku, Nagoya 464-8601, Japan
TEL
052-788-6258
ishida@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furo-cho, Chikusa-ku, Nagoya 464-8601, Japan
TEL
052-788-6258
Homepage URL
ishida@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Exercise and Sports Physiology, Graduate School of Medicine, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Graduate School of Medicine, Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
Tel
052-744-2479
ethics@med.nagoya-u.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
名古屋大学 総合保健体育科学センター（愛知県）
Research Center of Health, Physical Fitness and Sports, Nagoya University, Aichi, Japan
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
not released
Publication of results
Unpublished
Result
URL related to results and publications
not released
Number of participants that the trial has enrolled
47
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because there is a lot of data to analyze.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Cognitive function
Cadence
Cardio-respiratory responses
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032955
