UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049705
Receipt number R000056615
Scientific Title Differences in the effects of renal rehabilitation with and without diabetes
Date of disclosure of the study information 2022/12/07
Last modified on 2022/12/06 16:40:03

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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 or person

Institute

KKR Takamatsu Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056615


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name