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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034855
Receipt No. R000039744
Scientific Title Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial
Date of disclosure of the study information 2018/11/10
Last modified on 2019/10/05

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Basic information
Public title Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial
Acronym Effects of Home-based Exercise in CKD Stage 4 patients
Scientific Title Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial
Scientific Title:Acronym Effects of Home-based Exercise in CKD Stage 4 patients
Region
Japan

Condition
Condition CKD stage 4 patients
Classification by specialty
Endocrinology and Metabolism Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated effects of a home-based exercise program in CKD stage 4 patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Exercise capacity assessed by incremental shuttle walking test and quality of life, evaluated 6 months after assignment
Key secondary outcomes Parameters including renal function, arterial stiffness, body composition, grip and quadriceps strength evaluated 6 months after assignment
Cross-sectional association between exercise capacity and other parameters including HRQOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Regarding aerobic exercise, patients in the exercise group are asked to perform unsupervised walking thrice weekly for 6 months. The target training zone was set at 40-60% of the peak heart rate, as determined in the baseline incremental shuttle walking test.
Resistance training was prescribed at 40-70% of one repetition maximum (RM). One RM is the maximum amount of weight an individual can lift or press only once, and the target training weight was almost the same as the weight an individual could lift or press 10 times. Patients were instructed to train a variety of upper and lower body muscle groups for 1 set of 10 repetitions twice weekly.
Interventions/Control_2 No specific intervention
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with CKD stages 4 (estimated glomerular filtration rate,15-29 mL/min/1.73 m2)
Key exclusion criteria The exclusion criteria were as follows: uncontrolled hypertension (blood pressure [BP] >180/110 mmHg), severe anemia (hemoglobin level <7 mg/dL), active and proliferative diabetic retinopathy, symptomatic coronary artery disease or cerebrovascular disease within 3 months before study recruitment, current heart failure (New York Heart Association classes III and IV), symptomatic and fatal arrhythmia, significant valvular heart disease, and difficulty walking without a walking aid owing to orthopedic problems, a history of cerebrovascular disease, or a history of peripheral artery disease.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shu
Middle name
Last name Wakino
Organization Department of internal medicine, Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Zip code 160-8582
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(67441)
Email shuwakino@z8.keio.jp

Public contact
Name of contact person
1st name Kiyotaka
Middle name
Last name Uchiyama
Organization Department of internal medicine, Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Zip code 160-8582
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(67378)
Homepage URL
Email kiyo.0817.piyo@keio.jp

Sponsor
Institute Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine
Institute
Department

Funding Source
Organization None
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 Research Ethics Committee, Keio University, School of Medicine
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
Tel +81-3-3353-1211(62014)
Email med-rinri-jimu@adst.keio.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
2018 Year 11 Month 10 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 02 Day
Date of IRB
2018 Year 11 Month 08 Day
Anticipated trial start date
2018 Year 11 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2019 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039744

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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