UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038176 |
|---|---|
| Receipt number | R000043065 |
| Scientific Title | usefulness of abdominal breathing in self-training. |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/09/30 18:48:54 |
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Basic information
Public title
usefulness of abdominal breathing in self-training.
Acronym
usefulness of abdominal breathing in self-training.
Scientific Title
usefulness of abdominal breathing in self-training.
Scientific Title:Acronym
usefulness of abdominal breathing in self-training.
Region
| Japan |
Condition
Condition
After Total Hip Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consider the effect of abdominal breathing on walking behavior.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average load ratio and maximum load amount of surgical lower limbs in static standing posture.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Contents: abdominal breathing, frequency: 2 times / day, time: 10 minutes / times, duration: 10 days
Interventions/Control_2
Content: Standard treatment, duration: 10 days
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients over the age of 20 at the time of obtaining consent
(2) Patients who have determined that this study is appropriate
(3) Patients who have been sufficiently explained to participate in this study and have obtained written consent based on the patient's own free will with sufficient understanding
Key exclusion criteria
(1) Patients with higher brain dysfunction and cognitive decline
(2)Patients with postoperative leg length differences of more than 1.0 cm
(3) Patients with lower limb load limits after surgery
(4) Other subjects deemed inappropriate as those in charge of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | etsuo |
| Middle name | |
| Last name | chosa |
Organization
Miyazaki University Hospital
Division name
Department of Orthopaedic Surgery, Department of Sensory Motor Medicine, Miyazaki University School of Medicine
Zip code
889-1601
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-0986
chosa@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | tsubasa |
| Middle name | |
| Last name | kawaguchi |
Organization
Miyazaki University Hospital
Division name
Rehabilitation Department
Zip code
889-1601
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-9849
Homepage URL
tsubasa_kawaguchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Department of Sensory Motor Medicine, Miyazaki University School
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Department of Sensory Motor Medicine, Miyazaki University School
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
miyazaki university hospital clinical education support center
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-u.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 | 10 | Month | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043065
| 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 |
