UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035426
Receipt No. R000040358
Scientific Title Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients
Acronym Effects of CBT on vertebral compression fractures patients
Scientific Title Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients
Scientific Title:Acronym Effects of CBT on vertebral compression fractures patients
Region
Japan

Condition
Condition Vertebral compression fractures
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of B-SES on range of motion and muscle tone, and pain of disabled elderly patients with serious limitation of range of motion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain intensity (baseline, 2weeks, discharge)
Key secondary outcomes Physical activity
pain catastrophizing scale (PCS)
geriatric depression scale (GDS)-15
fall efficacy scale (FES)
thickness of quadriceps muscle
Isometric knee extension force
vertebral body collapse
physical performance (TUGT, 6MWD, 5SST)
functional independence measure
EuroQol 5 Dimension (EQ5-D)

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
Other
Interventions/Control_1 Intervention group: Participants in the intervention group are given pedometers, which they wear at all times when awake, and daily diaries, and asked to record their daily pain intensity, behaviour and step counts adding standard rehabilitation. Furthermore they undergo goal-setting intervention. Intervention period is from two to four weeks.
Interventions/Control_2 Control group: The contents of the standard rehabilitation are specific to each patient; for example, the rehabilitation included a muscle-strengthening exercise, balance training, activities of daily living (ADL) training, and instrumental ADL training.
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
60 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria of the present study included acute VCF patients, those who can walk with or without T-cane, those who can understand Japanese, those who agreed to the participation of the study.
Key exclusion criteria The exclusion criteria are fractures occured by high-energy traumas, patients who have severe cognitive dysfunction (Mini-Mental State Examination score is less than 23), and those have complications inhibiting rehabilitation (i.e. haemodynamically unstable, severe infection, and repeated vertebral fractures during hospital stay).
Target sample size 72

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kataoka Hideki
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Physical Therapy Sciences
Zip code
Address Sakamoto 1-7-1, Nagasaki, 852-8520, Japan
TEL 0958711515
Email kataoka-hide@kii.bbiq.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kataoka Hideki
Organization Nagasaki Memorial Hospital
Division name Department of Rehabilitation
Zip code
Address Hukahori 1-11-54, Nagasaki, 851-0301, Japan
TEL 0958711515
Homepage URL
Email kataoka-hide@kii.bbiq.jp

Sponsor
Institute Department of Physical Therapy Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 07 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
2019 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.