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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034651
Receipt No. R000039029
Scientific Title Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/17

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Basic information
Public title Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Acronym Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer
Scientific Title Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Scientific Title:Acronym Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer
Region
Japan

Condition
Condition Chronic kidney disease, hemodialysis
Classification by specialty
Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The resistance training intervention for 3months is performed for hemodialysis patients undergoing long-term intradialytic ergometer exercise in this study. The effect of combined use of aerobic exercise and resistance training on hemodialysis patients undergoing long-term ergometer exercise intervention is verified by comparing the evaluation of the physical function before and after combination with resistance training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Gait function before 3-months, before starting and after 3-months of exercise intervention.
Key secondary outcomes Muscle strength, balance ability, and body composition before 3-months, before starting and after 3-months of exercise intervention.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The subjects who are performing supine-position ergometer exercise during dialysis for more than 6 months add in low intensity resistance training before dialysis in this study. The resistance training covers the upper limb and lower limb muscles which can be easily performed by sitting position and standing position and should be voluntary training. The method of resistance exercise is shown graphic display, and at the time of introduction, practical instruction is given by a physical therapist (PT). In accordance with the cardiac rehabilitation guideline, we will teach the subjects to perform the exercise from 10 to 15 times as 1 set, and 2 to 3 sets in accordance with the individual's degree of fatigue. When exercise cannot be done, ask the reasons why it cannot be done, and re-instruct if there are problems concerning implementation.
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The hemodialysis patients who currently undergoing ergometer exercise during dialysis or currently do not exercise but want exercise. Currently, patients between 40 and 81 years old are carrying out.
Key exclusion criteria The patients who have not been approved by doctor about performing the resistance training or who have systolic blood pressure above 200 mmHg before exercise.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Noguchi
Organization Konjo University
Division name Faculty of Medical Health
Zip code
Address 1200,kasama-cho,hakusan City, Ishikawa ,Japan
TEL 076-276-4400
Email noguchi@kinjo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Moroe
Organization Mizuho hospital
Division name Rehabilitation
Zip code
Address 422-1,katabata,tsubata-cho,kahoku-gun, Ishikawa ,Japan
TEL 076-255-3008
Homepage URL
Email mizuho@tiara.ocn.ne.jp

Sponsor
Institute Mizuho hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2018 Year 11 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 25 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039029

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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