UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044568 |
|---|---|
| Receipt number | R000050911 |
| Scientific Title | Effects of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2023/01/26 18:08:50 |
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Basic information
Public title
Effects of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Acronym
Effects of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Scientific Title
Effects of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Scientific Title:Acronym
Effects of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Region
| Japan |
Condition
Condition
Patients after total knee arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A systematic review and meta-analysis to determine the effect of combined exercise and psychological interventions on psychological factors in patients after total knee arthroplasty for knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression
Anxiety
Pain catastrophizing
Self efficacy
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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) Patients who underwent total knee replacement surgery for osteoarthritis
2) The experimental group consisted of patients who received both exercise and psychological interventions
3) The control group consisted of patients who received exercise intervention only or psychological intervention only
4) Randomized controlled trial
Key exclusion criteria
1) Patients with rheumatoid arthritis
2) Patients with systemic lupus erythematosus
3) Patients after bilateral total knee arthroplasty
4) Patients after revision knee arthroplasty
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation
Zip code
350-8550
Address
1981 Kamoda, Kawagoeshi, Saitama
TEL
049-228-3529
j_nishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation
Zip code
350-8550
Address
1981 Kamoda, Kawagoeshi, Saitama
TEL
049-228-3529
Homepage URL
j_nishi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)Faculty of Health Sciences, Hiroshima Cosmopolitan University
2)Faculty of Medical Science, Fukuoka International University of Health and Welfare
3)Department of Rehabilitation, Kurashiki Heisei Hospital
4)Faculty of Health and Social Services, Kanagawa University of Human Services
5)Graduate school of Humanities and Social Sciences, Hiroshima University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Clinical Research Support Center, Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoeshi, Saitama
Tel
049-228-3606
j_nishi@saitama-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
| 2021 | Year | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods: In June 2021, we searched PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the The Physiotherapy Evidence Database (PEDro), and the Central Journal of Medicine (Ichushi) will be searched. The search strategy was a combination of free text words and Medical Subject Headings (MeSH) terms. The 2 concepts of intervention and outcome were combined with the AND operator. Intervention was defined as the combined use of exercise and psychological interventions. Outcomes were defined as psychological factors. For each concept, synonyms and Medical Subject Headings (MeSH) terms were combined with the OR operator.
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
