UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027240 |
|---|---|
| Receipt number | R000031207 |
| Scientific Title | The impact of made to order exercise on exercise self efficacy and adherence among the general older adults |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2017/05/03 20:44:22 |
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Basic information
Public title
The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Acronym
The impact of made to order exercise on exercise self efficacy
Scientific Title
The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Scientific Title:Acronym
The impact of made to order exercise on exercise self efficacy
Region
| Japan |
Condition
Condition
general older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to elucidate the efficacy of the made to order exercise on exercise self-efficacy and adherence compared to traditional exercise in the general older adults who has not exercise habits
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
exercise self-efficacy score at 12-months after intervention
Key secondary outcomes
1)exercise self-efficacy score at 3 to 9-months after intervention
2)adherence
3)locomotive syndrome
4)incidence of falling
5) physical function; gait speed, gait acceleration, grip power and pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
prescribe the made to order exercise using automatic exercise prescription on PC software
Interventions/Control_2
prescribe the traditional exercise by simple pamphlet
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)who aged 65 years old to 74 years when they were imformed consent
2) who are not exercise habits
3) who are gait imdependently
4) who can be assess the physical performance tests
5) who are imformed consent
Key exclusion criteria
1) who are locomotive syndrome
2) who are sarcopenia
3)who had severe comobities
4)who had a fragility fracture
5)who had a surgery for arthoroplasty
6)who had a nursing care insurance since one year
7) who had a health problems since one year
8) resarchers desided the subjects are not appropriate in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Matsumoto |
Organization
Tottori University Hospital
Division name
Rehabilitation Division
Zip code
Address
Nishicho 36-1, Yonago, Tottori
TEL
0859-38-6862
h.matsumoto@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Wada |
Organization
Tottori University Hospital
Division name
Rehabilitation Division
Zip code
Address
Nishicho 36-1, Yonago, Tottori
TEL
0859-38-6862
Homepage URL
t.wada@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
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
Address
Tel
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
| 2017 | Year | 05 | Month | 31 | 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
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031207
