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
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
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
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
