UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044000 |
|---|---|
| Receipt number | R000050242 |
| Scientific Title | Identification of effects related to improving physical activity by health education and fitness promotion in community dwelling older adults |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2022/10/24 09:30:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identification of effects related to improving physical activity by health education and fitness promotion in community dwelling older adults
Acronym
Identification of physical activity improvement effect by health education and fitness promotion
Scientific Title
Identification of effects related to improving physical activity by health education and fitness promotion in community dwelling older adults
Scientific Title:Acronym
Identification of physical activity improvement effect by health education and fitness promotion
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of physical activity improvement by health education and fitness promotion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of steps and physical activity time
Key secondary outcomes
Physical function (such as walking speed and balance)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Health education and fitness promotion for encouragement of physical activity, and mail-based behavioral change program
Interventions/Control_2
Health education and fitness promotion for encouragement of physical activity
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Up to 200 older adults participating to who used preventive health care services provided by the City Council of Social Welfare.
2. Among them, the consent of the document was obtained with the free will of the person who participated in this study.
Key exclusion criteria
1.With severe cardiac, pulmonary, diabetes, or kidney disease or musculoskeletal disorders
2.Having diagnosis of mental illness
3.With severe cognitive impairment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tashiro |
| Middle name | |
| Last name | Hideyuki |
Organization
Sapporo Medical University
Division name
First division of Physical Therapy
Zip code
0608556
Address
W17-S1, Cyuo-ku, Sapporo city, Hokkaido
TEL
011-611-2111
tashirohideyuki@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tashiro |
| Middle name | |
| Last name | Hideyuki |
Organization
Sapporo Medical University
Division name
First division of Physical Therapy
Zip code
0608556
Address
W17-S1, Cyuo-ku, Sapporo city, Hokkaido
TEL
0116112111
Homepage URL
tashirohideyuki@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Sapporo Medical University
Address
W17-S1, Cyuo-ku, Sapporo city, Hokkaido
Tel
0116112111
tetsuya.tamada@sapmed.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
| 2021 | Year | 04 | Month | 21 | 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
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
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050242
