UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053597 |
|---|---|
| Receipt number | R000061160 |
| Scientific Title | Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/02/11 01:56:55 |
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Basic information
Public title
Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly
Acronym
Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly
Scientific Title
Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly
Scientific Title:Acronym
Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly
Region
| Asia(except Japan) |
Condition
Condition
pretesr-posttest
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determining the effect and sustainability of a course of strength-functional exercises on the physical and mental health of the sedentary elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static balance, dynamic balance, fear of falling, flexibility
Key secondary outcomes
Strength, endurance, agility, movement speed, quality of life, quality of sleep
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Strength-functional training
Interventions/Control_2
Control
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
| 55 | years-old | < |
Age-upper limit
| 77 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among the criteria for entering the research is that the subjects do not have acute injuries to the head, spine, hip, thigh, knee, ankle, and other injuries that affect the balance and performance of the individual, as well as subjects who have a history of Those who did not eat due to eating disorder will be selected as subjects. In addition, elderly people with diseases such as diabetes, who may not have a negative effect on their posture control and balance, and who can perform exercises based on the discretion of the person in charge at the nursing home, will be included in the research. On the other hand, all the subjects will participate in this research with the approval of the relevant official in the nursing home and with the full consent of themselves and their families.
Key exclusion criteria
Among the criteria for exiting the current research is the unwillingness to continue the research or the observation of disability to the extent that the person is unable to perform exercises or tests, absence in two consecutive sessions or three non-consecutive sessions during the study. Also, if the person in charge of the nursing home or the researcher determines that the subject is not able to take a test or that taking the test may be traumatic for the person, the person will be removed from the research process.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hamed |
| Middle name | |
| Last name | Babgoltabar Samakoush |
Organization
Mazandaran University
Division name
Sport
Zip code
00989114581408
Address
Mazandaran-Babolsar-Pasdaran Street-postal code 57447-47419
TEL
00989114581408
Hb.sama@yahoo.com
Public contact
Name of contact person
| 1st name | Hamed |
| Middle name | |
| Last name | Babgoltabar Samakoush |
Organization
Mazandaran University
Division name
Sport
Zip code
00989114581408
Address
Mazandaran-Babolsar-Pasdaran Street-postal code 57447-47419
TEL
00989114581408
Homepage URL
Hb.sama@yahoo.com
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shahrood University of Technology
Address
Shahrood - Haft Tir Square - Shahrood University of Technology
Tel
00989114581408
Hb.sama@yahoo.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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061160
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
