UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise training in peritoneal dialysis patients
Title of the study (Brief title)	Exercise training in peritoneal dialysis patients
Region	Japan

Condition
Condition	Peritoneal dialysis patients
Classification by specialty	Endocrinology and Metabolism Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of 12-week home-based exercise training in peritoneal dialysis patients. Primary endpoint includes aerobic capacity and quality of life, and secondary endpoint includes parameters such as muscle strength, residual renal function, cholesterol, arterial stiffness.
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 shuttle walking test and quality of life, evaluated 12 weeks after assignment
Key secondary outcomes	Parameters including muscle strength,residual renal function, cholesterol, arterial stiffness, evaluated 12 weeks after assignment

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Twelve-week home-based exercise training, including 20-30 minutes of aerobic exercise thrice-weekly and resistance training twice-weekly. Exercise intensity is determined by the result of shuttle walking test and major muscle testing at baseline. Aerobic exercise and resistance training are performed with the target of 40-60% of the peak oxygen uptake (VO2peak) and 70% of 1 repetition maximum (RM), respectively.
Interventions/Control_2	No treatment
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	1) Peritoneal dialysis outpatients. 2) Patients from whom written informed consent was obtained.
Key exclusion criteria	1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases. 2) Unstable PD patients. Concrete criteria are as follows: patients who undergo PD less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L). 3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Target sample size	48

Research contact person
Name of lead principal investigator	Shu Wakino
Organization	Department of internal medicine, Keio University, School of Medicine
Division name	Division of Endocrinology, Metabolism and Nephrology
Address	35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL	+81-3-3353-1211(-0535)
Email	shuwakino@z8.keio.jp

Public contact
Name of contact person	Kiyotaka Uchiyama
Organization	Department of internal medicine, Keio University, School of Medicine
Division name	Division of Endocrinology, Metabolism and Nephrology
Address	35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL	+81-3-3353-1211(-0588)
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)

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	2016 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 18 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 19 Day
Last modified on	2018 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027068