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 2024/02/28 10:06:55

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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

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 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

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

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

2024 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=R000032955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name