UMIN-CTR Clinical Trial

Basic information
Public title	Differences in the effects of renal rehabilitation with and without diabetes
Acronym	Differences in the effects of renal rehabilitation with and without diabetes
Scientific Title	Differences in the effects of renal rehabilitation with and without diabetes
Scientific Title:Acronym	Differences in the effects of renal rehabilitation with and without diabetes
Region	Japan

Condition
Condition	chronic renal failure
Classification by specialty	Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the difference in the effects of renal rehabilitation (rate of change in upper and lower extremity muscle strength over a one-year period) depending on the presence or absence of diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Grip strength, knee extension muscle strength, toe muscle strength
Key secondary outcomes

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	Stretching, resistance training, aerobic exercise
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	30 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing renal rehabilitation among hemodialysis patients
Key exclusion criteria	1.Subjects with a history of musculoskeletal disease or cerebrovascular disease 2. Subjects who have difficulty walking due to deformities of hip joints, knee joints, ankle joints, and toes. 3. Those who are difficult to evaluate and measure 4. Subjects who were unable to continue renal rehabilitation 5. In addition, those who are judged to be inappropriate as subjects by the attending physician or the principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shion Middle name Last name Nagai
Organization	KKR Takamatsu Hospital
Division name	rehabilitation center
Zip code	760-0018
Address	4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
TEL	087-861-3261
Email	slmdpt.22@gmail.com

Public contact
Name of contact person	1st name Shion Middle name Last name Nagai
Organization	KKR Takamatsu Hospital
Division name	rehabilitation center
Zip code	760-0018
Address	4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
TEL	087-861-3261
Homepage URL
Email	slmdpt.22@gmail.com

Sponsor
Institute	KKR Takamatsu Hospital
Institute
Department

Funding Source
Organization	KKR Takamatsu Hospital
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	KKR Takamatsu Hospital
Address	4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
Tel	087-861-3261
Email	slmdpt.22@gmail.com

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	2022 Year 12 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	28
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	2022 Year 12 Month 05 Day
Date of IRB	2022 Year 05 Month 10 Day
Anticipated trial start date	2022 Year 12 Month 05 Day
Last follow-up date	2022 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 12 Month 06 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056615