UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the efficacy of speed feedback therapy system incorporating upper and lower extremities ergometer on the cognitive function of older adults with dementia
Title of the study (Brief title)	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	Hitoshi Okamura
Organization	Hiroshima University
Division name	Institute of Biomedical & Health Sciences
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5450
Email	hokamura@hiroshima-u.ac.jp

Public contact
Name of contact person	Hitoshi Okamura
Organization	Hiroshima University
Division name	Institute of Biomedical & Health Sciences
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5450
Homepage URL
Email	hokamura@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025757