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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038176
Receipt No. 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

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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
Email 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
Email tsubasa_kawaguchi@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Department of Sensory Motor Medicine, Miyazaki University School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043065

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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