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 2020/07/22 15:02:03

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

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

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

2020 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name