UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051880 |
|---|---|
| Receipt number | R000055373 |
| Scientific Title | Effects of ACcuraTe feedback of IntensiVE physical activity monitoring and educational intervention for multi-person in Preventive Care facility: A prospective, randomized, parallel-group, outcome blinded, controlled, factorial study (ACTIVE-PC) |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/10 05:20:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of ACcuraTe feedback of IntensiVE physical activity monitoring and educational intervention for multi-person in Preventive Care facility: A prospective, randomized, parallel-group, outcome blinded, controlled, factorial study (ACTIVE-PC)
Acronym
ACTIVE-PC
Scientific Title
Effects of ACcuraTe feedback of IntensiVE physical activity monitoring and educational intervention for multi-person in Preventive Care facility: A prospective, randomized, parallel-group, outcome blinded, controlled, factorial study (ACTIVE-PC)
Scientific Title:Acronym
ACTIVE-PC
Region
| Japan |
Condition
Condition
Preventive care facility users
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of user education using a physical activity monitoring device for preventative care facility users in improving the amount of physical activity through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average amount of physical activity during the 7 days prior to the end of the study
Key secondary outcomes
Safety of the intervention, adherence to wearing an accelerometer, changes in physical activity, number of steps, activity time, calories burned, walking speed, isometric knee extension muscle strength, quality of life (QOL), grip strength, achievement of activity goals, satisfaction with activity management, and discrepancy between measured activity and activity forecast by facility staff
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Physical activity education using multi-person physical activity monitor
Interventions/Control_2
Usual Care (accelerometer loan only)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients using preventive care facility
2) Aged 40 years or older
Key exclusion criteria
Persons who cannot give consent to this study
Those who have been instructed by a physician or other health care provider to limit their physical activity
Those who have difficulty walking outdoors unassisted.
Other participants who are deemed inappropriate by the staff.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
Department of Rehabilitation, School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788883
k-kamiya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yamshita |
Organization
ARCE Inc.
Division name
Division of Research
Zip code
252-0306
Address
4-2-1F Sakae-cho, Minami-ku, Sagamihara, Kanagawa
TEL
0427018737
Homepage URL
mss.yamashita.pt@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Graints-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Health Promotion, ARCE Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Kitasato University School of Allied Health Sciences
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
Tel
0427789602
a-soumu@kitasato-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
| 2023 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | 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
| 2023 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055373
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
