UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035524 |
|---|---|
| Receipt number | R000040473 |
| Scientific Title | Influence of wearing shoe type on the consequences of a fall prevention exercise program in the older adults |
| Date of disclosure of the study information | 2019/01/17 |
| Last modified on | 2020/10/30 21:06:02 |
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Basic information
Public title
Added value of accounting for wearing unstable shoes during an agility-based circuit training among older adults
Acronym
value of wearing unstable shoes among older adults
Scientific Title
Influence of wearing shoe type on the consequences of a fall prevention exercise program in the older adults
Scientific Title:Acronym
value of wearing unstable shoes among older adults
Region
| Asia(except Japan) |
Condition
Condition
older adult
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate effects of wearing unstable shoes during an agility-based circuit training among older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Balance
Key secondary outcomes
Ankle plantar flexor muscle strength
Mobility
Postural stability
Fear of falling
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing unstable shoes and agility-based circuit training
Interventions/Control_2
Wearing usual shoes and agility-based circuit training
Interventions/Control_3
Control
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria: Age over 65 years; Independent living in the community.
Key exclusion criteria
Exclusion criteria: History of bone metabolic disease and corticosteroids consumption; history of severe musculoskeletal disorders (such as lower back , knee or hip joint arthritis) and / or arthroscopy and artificial implants; history of neurological complications/problems (such as Parkinson's disease, stroke, spinal cord injury and cerebral palsy).
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Department of Health and Corrective Exercise, School of Sport Sciences
Zip code
3619995161
Address
Shahrood, Semnan, Iran
TEL
+899177217462
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Department of Health and Corrective Exercise, School of Sport Sciences
Zip code
3619995161
Address
Shahrood, Semnan, Iran
TEL
+899177217462
Homepage URL
ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
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
Institute of higher education in civil and development
Address
Hamedan, Iran
Tel
+9186726462
bagherishahab@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
| 2019 | Year | 01 | Month | 17 | 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
75
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
| 2019 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040473
