UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052092 |
|---|---|
| Receipt number | R000059454 |
| Scientific Title | Effectiveness of feedback based on postoperative physical activity in patients undergoing lower limb arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2023/09/03 |
| Last modified on | 2024/04/16 14:12:10 |
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Basic information
Public title
Effectiveness of feedback based on postoperative physical activity in patients undergoing lower limb arthroplasty: a randomized controlled trial
Acronym
Effectiveness of feedback based on postoperative physical activity in patients undergoing lower limb arthroplasty: a randomized controlled trial
Scientific Title
Effectiveness of feedback based on postoperative physical activity in patients undergoing lower limb arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Effectiveness of feedback based on postoperative physical activity in patients undergoing lower limb arthroplasty: a randomized controlled trial
Region
| Japan |
Condition
Condition
Knee osteoarthritis, Hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of providing feedback based on step counts visualized by a smartphone app in addition to standard postoperative rehabilitation on postoperative functional recovery in patients undergoing primary total knee or hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in Timed Up and Go Test before and at 3 months after surgery
Key secondary outcomes
1. Difference in average daily physical activity (number of steps) before and at 1 year after surgery
2. Comparison of the following items between preoperatively and at 3 months and 1 year postoperatively.
a)Pain at the surgical site (Numerical Rating Scale) b)Presence or absence of regular analgesic use c)Thigh/lower leg circumference d)Joint range of motion (extension and flexion angle)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will receive standard postoperative rehabilitation. In addition, if the patient is judged by the rehabilitation staff to be able to walk without supervision, step counting will be started and feedback based on step counts will be provided via the application continuously for up to one year postoperatively. And during hospitalization, the rehabilitation staff will also check the use of the app, provide additional guidance on its use if necessary, share the progress of the step counts and provide feedback accordingly.
Interventions/Control_2
The control group will receive standard postoperative rehabilitation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Osteoarthritis patients undergoing primary knee or hip arthroplasty (single-joint affected / multiple-joint affected but have already undergone arthroplasty except for the current surgical site)
2. Patients over 18 years old
3. Patients who use a smartphone capable of using the application
Key exclusion criteria
1. Patients who are unable to walk before surgery
2. Patients with dementia and those who have difficulty understanding and consenting to Japanese documents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-4400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Ikeuchi |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-4400
Homepage URL
pa_study@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Taku Iwami
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Matsuyama Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
C1630
Org. issuing International ID_1
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 03 | 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
| 2023 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059454
