UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049931 |
|---|---|
| Receipt number | R000056867 |
| Scientific Title | Prospective observational study of physical activity in patients with spinal metastases |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 11:01:28 |
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Basic information
Public title
Prospective observational study of physical activity in patients with spinal metastases
Acronym
Prospective observational study of physical activity in patients with spinal metastases
Scientific Title
Prospective observational study of physical activity in patients with spinal metastases
Scientific Title:Acronym
Prospective observational study of physical activity in patients with spinal metastases
Region
| Japan |
Condition
Condition
metastatic spinal tumor
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore changes in physical activity and its factors during treatment in patients with spinal metastases undergoing inpatient radiotherapy and physiotherapy.
Basic objectives2
Others
Basic objectives -Others
To identify the optimal amount of physical activity that can prevent both disuse syndrome and bone-related events by exploring changes in physical activity and its factors during treatment in patients with spinal metastases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage recovery of physical activity and factors affecting it at 3 months post-treatment(T3), using pre-treatment physical activity assessed by GPAQ(Global Physical Activity Questionnaire) as baseline.
Key secondary outcomes
a) Mean and difference in number of steps and exercise intensity evaluated by Lifecorder
b) Relationship between pain, corset compliance, and physical activity
c) Correlation of various factors with nutritional status, anxiety and depression, and skeletal muscle mass
d) Relationship between QOL(quality of life), physical activity, and physical function
e) Trends in activity and motor function 6 months after treatment and their factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cancer patients who received cancer treatment at Shizuoka Cancer Center and were diagnosed with spinal metastasis
2) Patients with spinal metastases requiring inpatient bed rest and undergoing radiotherapy and physical therapy
3) Patients undergoing radiotherapy to the spine (cervical, thoracic, lumbar, and sacral) at doses of 20 Gy or more, whether single or multiple metastases
4) Patients who expected to be able to walk (with or without assistance) after treatment and to be discharged home
5) Patients who can read and write Japanese and obtain written consent
Key exclusion criteria
1) Patients with significantly poor prognosis for life (new Katagiri score of 8 or more points)
2) Patients with severe paralysis of the lower extremities (modified Frankel classification A-C1)
3) Patients who have difficulty walking due to other factors even before the onset of spinal metastases
4) Patients scheduled for orthopedic surgery on the spine or extremity bones contiguous with radiotherapy
5) Patients who have difficulty accurate listening to accurate questionnaires due to mental impairment or cognitive decline
6) Patients deemed by the physician in charge to be inappropriate for this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | midori |
| Middle name | |
| Last name | unnno |
Organization
Shizuoka Cancer Center
Division name
Division of Rehabilitation Medicine
Zip code
411-8777
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
mi.kitagawa@scchr.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Unno |
Organization
Shizuoka Cancer Center
Division name
Division of Rehabilitation Medicine
Zip code
411-8777
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
mi.kitagawa@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
tansaku_office@scchr.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
| 2022 | Year | 12 | Month | 28 | 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
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056867
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