UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045511 |
|---|---|
| Receipt number | R000051518 |
| Scientific Title | A study on self-care for alleviating cold symptoms in the elderly |
| Date of disclosure of the study information | 2021/09/18 |
| Last modified on | 2023/05/02 12:50:17 |
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Basic information
Public title
A study on self-care for alleviating cold symptoms in the elderly
Acronym
A study on self-care for alleviating cold symptoms in the elderly
Scientific Title
A study on self-care for alleviating cold symptoms in the elderly
Scientific Title:Acronym
A study on self-care for alleviating cold symptoms in the elderly
Region
| Japan |
Condition
Condition
cold symptoms
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual condition of poor circulation in the elderly men and develop self-care to alleviate the cold symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implement the conditions under which the subject does not perform the hot compress (non-compressive method) and the conditions under which the warm compress is performed (compressor). Each experiment should be conducted at least one day apart. The measurement items are shown below.
Target subjects' basic attributes: age, health status
Biological reactions: blood pressure, pulse, respiration, core temperature, skin surface temperature (toes, back of feet, palms, back of hands)
Subjective evaluation: Whole body temperature sensation (BTS: Body Thermal Sensations), Comfort sensation (PS: Pleasant Sensations)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Warm compress - washout period - no compress
Interventions/Control_2
No compress - washout period - warm compress
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
Key inclusion criteria
Elderly men who are aware of the symptoms of cold
Key exclusion criteria
Those with arteriosclerosis obliterans, diabetes and thyroid disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Kuga |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences,Dept. of Nursing
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine-ku, Sapporo
TEL
011-688-7146
kuga-k@hus.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kuga |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences,Dept. of Nursing
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine-ku, Sapporo
TEL
011-688-2161
Homepage URL
kuga-k@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research | Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science Ethics Committee
Address
7-15-4-1 Maeda, Teine-ku, Sapporo
Tel
0116882241
kenkyu@hus.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 | 09 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051518
