UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055942 |
|---|---|
| Receipt number | R000063929 |
| Scientific Title | Association between depressive symptoms and self-training during inpatient rehabilitation in patients with orthopedic fractures |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2024/11/05 10:04:35 |
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Basic information
Public title
Relationship between depressive symptoms and self-training in rehabilitation after fractures in older adults
Acronym
Relationship between depressive symptoms and self-training in rehabilitation after fractures in older adults
Scientific Title
Association between depressive symptoms and self-training during inpatient rehabilitation in patients with orthopedic fractures
Scientific Title:Acronym
Association between depressive symptoms and self-training during inpatient rehabilitation in patients with orthopedic fractures
Region
| Japan |
Condition
Condition
Vertebral body fracture, proximal femoral fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of depressive symptoms on self-initiated exercise time in patients undergoing rehabilitation for orthopedic fractures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of actual ergometer exercise during a self-initiated training session
Key secondary outcomes
Distance covered during ergometer exercise
FIM score at discharge
Length of hospital stay
Relative intensity of self-training
MORE scale score
Apathy Scale score
MFI score
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 70 and 90 years
Inpatient with vertebral body fracture or proximal femoral fracture
More than one week after admission
Able to continue recumbent ergometer exercise for about 5 minutes without assistance
Has cognitive and language functions to understand experimental procedures
Can safely perform ergometer exercise under distant supervision without risk of falling
Key exclusion criteria
Meeting rehabilitation discontinuation criteria
Having joint contractures, orthopedic conditions, or pain that limits exercise performance
Having mental or neurological disorders that make research participation difficult
Taking psychotropic medications for depression or anxiety
Deemed inappropriate for study participation by researchers
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2111
tanakas@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2111
Homepage URL
tanakas@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
JA Shizuoka Kohseiren Enshu Hospital
Shinshu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-435-2111
rinri@hama-med.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 | 06 | 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 | 08 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 10 | 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
This study will classify patients into two groups based on depression symptoms (GDS score): depression group (GDS more than or equal to 7) and non-depression group (GDS less than or equal to 6), and proceed as follows:
Initial Assessment:
Depression symptoms (GDS), cognitive function (MMSE), activities of daily living (FIM), physical fitness (6-minute walk test)
Pre-observation Period:
Familiarization with bicycle ergometer exercise
Assessment of apathy (Apathy Scale), rehabilitation motivation (MORE scale), fatigue (MFI), motor function (SPPB)
Setting exercise intensity at Borg scale 12-14
Observation Period (5 days):
Daily 18-minute self-exercise sessions
Measurement of actual exercise time under distant supervision
Discharge Assessment:
Activities of daily living (FIM), length of hospital stay
Analysis Plan:
Primary Analysis:
Comparison of self-exercise time between depression and non-depression groups
Calculation of effect size (Cohen's d)
Secondary Analysis:
Correlation analysis between depression symptoms (GDS) and self-exercise time
Analysis of relationships between Apathy (Apathy Scale), fatigue (MFI), motivation (MORE scale) and self-exercise time
Analysis of relationships between self-exercise time and discharge FIM score, length of stay
*Correction made to GDS cutoff value due to a typo. Corrected on 2024/11/05 before start of research.
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063929
