UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055522 |
|---|---|
| Receipt number | R000063402 |
| Scientific Title | Factors associated with day-to-day step count variability in patients undergoing outpatient physical therapy. |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2025/03/19 10:56:31 |
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Basic information
Public title
How can we increase the levels of physical activity among patients in chronic phase?
Acronym
How can we increase the levels of physical activity among patients in chronic phase?
Scientific Title
Factors associated with day-to-day step count variability in patients undergoing outpatient physical therapy.
Scientific Title:Acronym
Factors associated with day-to-day step count variability in patients undergoing outpatient physical therapy.
Region
| Japan |
Condition
Condition
Patients undergoing outpatient physical therapy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to identify factors associated with the day-to-day step count variability in patients undergoing outpatient physical therapy.
The secondary objective is to explore the needs of patients for outpatient physical therapy services to increase their levels of physical activity.
Basic objectives2
Others
Basic objectives -Others
The primary objective is to identify factors associated with the day-to-day step count variability in patients undergoing outpatient physical therapy.
The secondary objective is to explore the needs of patients for outpatient physical therapy services to increase their levels of physical activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity outcomes: daily step counts (steps/day), sedentary time (%), light intensity activity time (%), moderate-to-vigorous intensity activity time (%)
Key secondary outcomes
Mental health outcomes: Self-Rating Depression Scale, Apathy Scale, Falls Efficacy Scale-International.
Functional outcome: Short Physical Performance Battery.
Potential factors associated with daily physical activity levels: instrumental activities of daily living performed, life-space mobility, potential barriers to physical activity, occurrence of falls.
Information obtained from interviews: patients' perspectives on the causes of day-to-day step count variability, the needs of patients for outpatient physical therapy services to increase their levels of physical activity.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Having received outpatient physical therapy at least once a week.
Able to perform household walking without manual assistance, regardless of the use of walking aids or orthoses.
Consent to participate in this study.
Key exclusion criteria
Habitually engages in swimming as a deliberate form of physical activity.
Motor impairments, cognitive decline, and mental disorders that interfere with the ability to operate physical activity monitoring devices and reliably record factors associated with physical activity levels.
Inappropriate patients due to other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
k_oyake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Satomura |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino, Chiba
TEL
047-453-9000
Homepage URL
m.satomura752@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Kazuaki Oyake
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
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
東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
To examine the associations between the magnitude of day-to-day step count variability and characteristics of patients.
To compare physical activity-related factors, such as instrumental activities of daily living performed and the extent of mobility, between days with the highest and lowest daily step counts within a week.
To explore patients' perspectives on the causes of day-to-day step count variability.
To explore the needs of patients for outpatient physical therapy services to increase their levels of physical activity.
Management information
Registered date
| 2024 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063402
