UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049768 |
|---|---|
| Receipt number | R000056689 |
| Scientific Title | Examination of the efficacy and safety of online group exercise therapy for elderly patients with lifestyle-related diseases |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2023/06/14 16:57:29 |
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Basic information
Public title
Examination of the effect and safety of exercise therapy using a video conference system for elderly patients with lifestyle-related diseases
Acronym
Elderly with lifestyle disease online exercise therapy research
Scientific Title
Examination of the efficacy and safety of online group exercise therapy for elderly patients with lifestyle-related diseases
Scientific Title:Acronym
EH-ONEx-Study
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects and safety of online group exercise therapy on motor function and blood test data
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standing time on one leg
Key secondary outcomes
Presence or absence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group performs exercise therapy using a video conference system for 50 minutes once a week for 12 weeks
Interventions/Control_2
The control group performs face-to-face exercise therapy for 50 minutes once a week for 12 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
After receiving an explanation about participating in this study, after understanding, consent in writing of the patient's own free will was obtained
Key exclusion criteria
1. Those with dementia
2.Those with neuromuscular diseases, etc.
3.Severe motor paralysis
4. Subjects with acute metabolic disorders
5.Those who are judged to be inappropriate as subjects by the attending physician or research director
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Aizawa |
Organization
Misaki Medical Clinic
Division name
Exercise consultation room
Zip code
2740805
Address
6-44-9 Futawahigashi, Funabashi City, Chiba Prefecture
TEL
0474402222
f.aizawa130@gmail.com
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Aizawa |
Organization
Misaki Medical Clinic
Division name
Exercise consultation room
Zip code
2740805
Address
6-44-9 Futawahigashi, Funabashi City, Chiba Prefecture
TEL
0474402222
Homepage URL
f.aizawa130@gmail.com
Sponsor or person
Institute
Misaki Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
The Taiyo Life Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Misaki Medical Clinic Ethics Group
Address
6-44-9 Futawahigashi, Funabashi City, Chiba Prefecture
Tel
0474402222
misakin-ethics@googlegroups.com
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
| 2022 | Year | 12 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056689
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
