UMIN-CTR Clinical Trial

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	46
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 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	2020 Year 11 Month 20 Day

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