UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040309 |
|---|---|
| Receipt number | R000045990 |
| Scientific Title | Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients:A pilot study |
| Date of disclosure of the study information | 2020/05/05 |
| Last modified on | 2023/11/07 19:12:53 |
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Basic information
Public title
Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Acronym
Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Scientific Title
Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients:A pilot study
Scientific Title:Acronym
Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effectiveness of a rehabilitation approach based on the theory of behavior modification for elderly patients with knee osteoarthritis based on the basic information (Gender, age, complications, height, weight), HRQOL, instrumental ADL (Instrumental Activities of Daily Living: IADL), fear of falling, and depression, and to examine the effectiveness of a rehabilitation probe based on the theory of behavior modification for patients with knee osteoarthritis aged 65 years and older who underwent rehabilitation in our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HRQOL score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
behavioral modification theory
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)A Case of Conservative Treatment for Knee Osteoarthritis after Rehabilitation in our hospital
2)Age: 65 years or older
3)Gender: both sexes
4)After sufficient informed consent to participate in this study, a voluntary written consent was obtained from the research subjects themselves.
Key exclusion criteria
1)When a research subject requests to decline participation in a study
2)If the research director decides that the subject person should be excluded for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthpedic surgery
Zip code
1018309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL
0332931711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University hospital
Division name
Orthpedic surgery
Zip code
1018309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL
0332931711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon University hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University hospital
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
Tel
0332931711
ntnyf092@yahoo.co.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
| 2020 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045990
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045990
Number of participants that the trial has enrolled
60
Results
JOA score, FES, FAI, GDS, and SF -8 improved significantly (p < 0.01). MCS was also negatively correlated with FES and age (r = -0.456, -0.368), and GDS and age were positively correlated (r = 0.453). Gender was extracted as a factor affecting the HRQOL scale at the last observation in PCS (p = 0.046). MCS was extracted with FES as a factor (p = 0.039).
Results date posted
| 2023 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between May 2020 and March 2022, 30 patients with osteoarthritis of the knee were treated conservatively and rehabilitated with a patient education program.
Participant flow
The patient education program was based on the Health Belief Model (HBM) by Sedlak et al., and patient education using pamphlets was provided during the rehabilitation intervention.
Adverse events
None
Outcome measures
The survey items were patient basic information, instrumental ADL (FAI), fear of falling (FES), degree of depression (GDS), HRQOL (SF -8), knee function assessment (JOA score), and X-ray classification (K-L classification), and the survey method was a self-administered questionnaire at the start of rehabilitation, 1 month after the intervention, and at the end of the rehabilitation intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045990
