UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037760 |
|---|---|
| Receipt number | R000043043 |
| Scientific Title | A home video exercise program improves ADL/QOL and kinesiophobia in the patients with lumbar spine surgery |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2019/08/21 19:07:01 |
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Basic information
Public title
A home video exercise program improves ADL/QOL and kinesiophobia in the patients with lumbar spine surgery
A randomized controlled trial
Acronym
Verification of effectiveness of video gymnastics program for patients after lumbar surgery
Using the patient pedestrian evaluation method
Scientific Title
A home video exercise program improves ADL/QOL and kinesiophobia in the patients with lumbar spine surgery
Scientific Title:Acronym
A home video exercise program improves ADL/QOL and kinesiophobia in the patients with lumbar spine surgery
Region
| Japan |
Condition
Condition
Lumbar disc herniation
Lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of introducing a video gymnastic program that can be performed at home after discharge from the hospital on pain, ADL, QOL, and mental status.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation items were (1) Visual Analog Scale (VAS), (2)Short Form-36 (SF-36), (3)Oswestry Disability Index (ODI), (4)Tampa Scale for Kinesiophobia (TSK), and (5)the Zung self-rating depression scale(SDS). We compared the scores at each
Key secondary outcomes
patient-reported outcomes (PROs) preoperatively and every day for 5 days after surgery, and at 1 month, 3 months, 6 months, 1 year and 2 years postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the standard treatment group (non-excersise group), patients underwent postoperative rehabilitation during the hospital stay, and nursing staffs provided daily life guidance at the time of discharge
Interventions/Control_2
In the excersise group, in addition to the standard treatment, patients underwent postoperative rehabilitation using the exercise DVD for low back pain, and received guidance to do the exercise once a day with watching the DVD at home after discharge. To check the implementation status of exercise, we asked patients to record it on a record diary.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Targeting cases of decompression between 1 and 3 vertebrae for lumbar degenerative diseases (lumbar disc herniation, lumbar spinal canal stenosis) at our department and related hospitals during the period from June 2010 to December 2012 It was.
Key exclusion criteria
Excluded were those complicated by diseases that interfered with daily activities such as cerebral infarction and osteoarthritis of the lower extremities.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryoko |
| Middle name | |
| Last name | Nishiyama |
Organization
Wakayama Medical University Hospital
Division name
Nursing Department
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300ext.3010
n-ryoko@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Nishiyama |
Organization
Wakayama Medical University Hospital
Division name
Nursing Department
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300ext.3010
Homepage URL
n-ryoko@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Wakayama Medical University, Wakayama, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Wakayama Medical University, Wakayama, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Ethics Committee
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300
wa-rinri@wakayama-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
| 2019 | Year | 08 | Month | 26 | 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
168
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
| 2009 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | 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
| 2019 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043043
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