UMIN-CTR Clinical Trial

Basic information
Public title	Physiotherapy on swallowing function
Acronym	Physiotherapy on swallowing function
Scientific Title	Physiotherapy on swallowing function
Scientific Title:Acronym	Physiotherapy on swallowing function
Region	Japan

Condition
Condition	Hip fracture and vertebral compression fracture
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aims to verify whether physiotherapy can contribute to swallowing function improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Tongue pressure
Key secondary outcomes	Swallowing function assessed using MASA.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Usual physiotherapy during in-hospital rehabilitation
Interventions/Control_2
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients admitted to a rehabilitation hospital for physiotherapy. 2) Sarcopenia diagnosed using AWGS criteria.
Key exclusion criteria	1) Patients prescribed dysphagia rehabilitation 2) Contraindication of measuring body composition 3) Error in measuring body composition 4) Disability in measuring tongue pressure 5) Disability in assessing swallowing function
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name MAEDA
Organization	Aichi Medical University
Division name	Palliative Care Center
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Japan
TEL	0561-62-3311
Email	kskmaeda@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name MAEDA
Organization	Aichi Medical University
Division name	Palliative Care Center
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Japan
TEL	0561-62-3311
Homepage URL
Email	kskmaeda@aichi-med-u.ac.jp

Sponsor
Institute	Okinawa Chuzan Clinical Research Center, Chuzan Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chuzan Hspital
Address	6-2-1Matsumoto, Okinawa, Japan
Tel	+81-98-982-1346
Email	keiri@chuzan.or.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	ちゅうざん病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 15 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	95
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	2018 Year 09 Month 10 Day
Date of IRB	2018 Year 09 Month 10 Day
Anticipated trial start date	2018 Year 11 Month 20 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry	2019 Year 07 Month 31 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 15 Day
Last modified on	2019 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039791