UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056104 |
|---|---|
| Receipt number | R000064100 |
| Scientific Title | Effect verification of a smartphone application to accelerate start and continuation of interval walking training |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/11/15 09:17:22 |
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Basic information
Public title
Development of a smartphone application to accelerate popularization of interval walking training
Acronym
Development of a smartphone application for interval walking training
Scientific Title
Effect verification of a smartphone application to accelerate start and continuation of interval walking training
Scientific Title:Acronym
Effect verification of a smartphone application for interval walking training
Region
| Japan |
Condition
Condition
lifestyle-related diseases and age-associated diseases
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Rehabilitation medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a smartphone application to accelerate start and continuation of interval walking training and to verify the effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The start rate of interval walking training
2) The continuation rate of interval walking training
Key secondary outcomes
1) Exercise volume
2) Exercise intensity
3) Physical characteristics (height, body weight, blood pressures)
4) Physical fitness (maximal aerobic capacity)
5) Blood composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A group which uses a smartphone application equipped with programs to accelerate start and continuation of interval walking training as well as with that to record achievements of the training
Interventions/Control_2
A group which uses a smartphone application equipped with only program to record achievements of interval walking training
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who are older than 40 yr or younger than 80 yr
2) Those who can walk with no help by others
3) Those who have not experienced interval walking training
4) Those who can use smartphone applications both for the plcebo and testing groups
5) Those who have given their informed consent to participate in the study after a full explanation by the investigators
Key exclusion criteria
1) Those who do not match any of the key inclusion criteria stated above.
2) Those who are judged as inappropriate subjects by the primary investigator
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Shinshu University School of Medicine, General Affairs Section
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2527
mdrinri@shinshu-u.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
| 2025 | Year | 02 | Month | 01 | 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 | 11 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064100
