UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022344
Receipt number R000025757
Scientific Title Study on the efficacy of speed feedback therapy system incorporating upper and lower extremities ergometer on the cognitive function of older adults with dementia
Date of disclosure of the study information 2016/05/18
Last modified on 2018/08/10 09:08:53

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Basic information

Public title

Study on the efficacy of speed feedback therapy system incorporating upper and lower extremities ergometer on the cognitive function of older adults with dementia

Acronym

Study on the efficacy of speed feedback therapy system in older adults with dementia

Scientific Title

Study on the efficacy of speed feedback therapy system incorporating upper and lower extremities ergometer on the cognitive function of older adults with dementia

Scientific Title:Acronym

Study on the efficacy of speed feedback therapy system in older adults with dementia

Region

Japan


Condition

Condition

dementia

Classification by specialty

Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of a speed feedback therapy system incorporating upper and lower extremities ergometer in terms of improving the cognitive function of older adults with dementia by using a randomized controlled trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mini-Mental State Examination (MMSE) score 3 months after completion of the intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention group: speed feedback therapy with the upper and lower extremities ergometer at a frequency of at least once a week, 5 minutes each time, 6 weeks

Interventions/Control_2

Control group: pedaling on the upper and lower extremities ergometer at a frequency of at least once a week, 5 minutes each time, 6 weeks

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. patients who are diagnosed with dementia
2. patients who are 65 years of age or older, and have been issued a Certification of Needed Support or Needed Long-Term Care
3. patients who can pedal the upper and lower extremities ergometer
4. patients for whom consent is obtained from the subjects or their family in writing

Key exclusion criteria

1. patients who have a past history of heart disease
2. patients who need a management of a medical risk required because of heart disease, hypertension, or diabetes mellitus
3. patients whom their attending physician does not allow to participate in the study
4. patients whom a research attending physician judges unsuitable for participating in the present study

Target sample size

112


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Okamura

Organization

Hiroshima University

Division name

Institute of Biomedical & Health Sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5450

Email

hokamura@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Okamura

Organization

Hiroshima University

Division name

Institute of Biomedical & Health Sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5450

Homepage URL


Email

hokamura@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

CHUDENKO CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Completed

Date of protocol fixation

2016 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 18 Day

Last modified on

2018 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025757


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name