UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022337 |
|---|---|
| Receipt number | R000024663 |
| Scientific Title | Exercise programs for improvement of cognitive, physical, and mental health of elderly people. |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2022/05/23 11:31:30 |
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Basic information
Public title
Exercise programs for improvement of cognitive, physical, and mental health of elderly people.
Acronym
Exercise programs for elderly people
Scientific Title
Exercise programs for improvement of cognitive, physical, and mental health of elderly people.
Scientific Title:Acronym
Exercise programs for elderly people
Region
| Japan |
Condition
Condition
dementia,Mild Cognitive Impairment, Normal
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined the influence of exercise and yoga on the cognitive, affective, and ADL functions of patients with dementia or mild cognitive impairment, and normal elderly people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of MMSE and CDR scores befor and after exercise and yoga intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise(20min/day, one more/week) for the first 6 months
Interventions/Control_2
exercise(20min/day, one more/week) for 6 months after 6 months follow-up
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Native Japanese people of 40 and above who regularly go to the Okayama University Hospital, Ibara City Hospital, Yubara Onsen hospital, Matsuura clinic, Mizunaga Rehabilitation Hospital, and their associated day-care center and day-care centers in Maniwa city.
Key exclusion criteria
The subjects who have neurogenerative diseases, stroke, brain tumor, epilepsy, multiple sclerosis, idiopathic normal pressure hydrocephalus, head injury, encephalitis,major depression, schizophrenia, bipolar disorder, alcohol dependence, the other drug dependence diseases, and could not be examined cognitive, affective and bodily functional tests.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Abe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Neurology
Zip code
7008558
Address
2-5-1 Shikatacho Kitaku, Okayama
TEL
+81-86-235-7365
nozomi-hishikawa@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Hishikawa |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Neurology
Zip code
7008558
Address
2-5-1 Shikatacho Kitaku, Okayama
TEL
+81-86-235-7365
Homepage URL
nozomi-hishikawa@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department Ethics Comittee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
2-5-1 Shikatacho Kitaku, Okayama
Tel
+81-86-235-7365
nozomi-hishikawa@okayama-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
done
Publication of results
Partially published
Result
URL related to results and publications
done
Number of participants that the trial has enrolled
385
Results
Mean scores on the frontal assessment battery, clock drawing test, cube copying test, letter fluency, and category fluency significantly improved after the Yoga intervention. Affective scores on GDS, AS and ABS were not significantly affected by exercise therapy, but subgroups with higher baseline GDS and AS scores showed a significant improvement after intervention. One-leg standing time and 3-m timed up and go test performance significantly improved after 12M intervention.
Results date posted
| 2021 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Increased attention is being paid to Asian medicine in balanced total health care. We investigated the effects of mixed exercise including yoga (Yoga-plus) among elderly individuals.
Participant flow
no
Adverse events
none
Outcome measures
MMSE, HDS-R and trail making test
geriatric depression scale, apathy scale and Abe behavioral
One-leg standing time, 3-m timed up and go test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024663
