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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028806
Receipt No. 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 2020/02/25

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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
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
Email 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
Email ishida@htc.nagoya-u.ac.jp

Sponsor
Institute Exercise and Sports Physiology, Graduate School of Medicine, Nagoya University
Institute
Department

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
Email 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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 47
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
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
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2020 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032955

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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