UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia: a randomized parallel-group pilot study
Title of the study (Brief title)	Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia
Region	Japan

Condition
Condition	Hemodialysis patients complicated with sarcopenia
Classification by specialty	Nephrology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of exercise plus nutritional supplementation with that of exercise alone on body composition, muscle function and nutritional status in sarcopenic patients receiving hemodialysis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	An amount change of the fat free mass
Key secondary outcomes	1. the value change of the skeletal muscle index, lower limb muscle mass, skeletal muscle mass, body cell mass, phase angle and body fat percentage 2. the amount change of the grip strength and knee extension strength 3. the value change of Short Physical Performance Battery(SPPB) 4. the value change of the Geriatric Nutrition Risk Index(GNRI) and Malnutrition-Inflammation Score(MIS) 5. the variation change in the biochemical parameters 6. the value change of the single-pool Kt/Vurea, normalized protein catabolic rate(nPCR) and the creatinine generation rate % (%CGR) 7. the incidence ratio of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Exercise therapy with combination of nutritional supplementation: Dietary supplements such as energy of 276kcal, protein of 6.3g, branched-chain amino acid of 1.54g are taken in each day for 12 weeks with the exercise therapy of intervention 2.
Interventions/Control_2	Exercise therapy: At the first half of hemodialysis which conducted three times a week, A resistance exercise for 20 to 30 minutes in each time, the level is from mild to moderate as the subjective exercise intensity(11 to 13 in Borg index) is worked out for 12 weeks.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects were enrolled after meeting all the following criteria. 1. Patients have undergone hemodialysis or hemodiafiltration three times a week for more than three months 2. Out-patients 3. Patients, 18 years age or older at the time of submitting written informed consent 4. Patients, after receiving a sufficient explanation upon participation in this study, agreed the consent document in full understanding and with a free will were enrolled as a subject 5. Patients who were diagnosed sarcopenia and pre-sarcopenia in the standard of Asian Working Group for sarcopenia(AWGS)
Key exclusion criteria	Persons, met any of the following criteria were excluded. 1. Patients not ensured of an adequate dialysis(below 1.2 in single-pool Kt/Vurea) 2. Patients with cardiovascular disease such as heart failure likely worsening within one week, unstable angina pectoris, myocardial ischemia induced with a low threshold value by slow walking on the level ground(2METS), a candidate for surgery of severe valvular disease, and exercise-induced arrhythmias 3. Patients with an acute systemic disease or fever 4. Patients with complicated severe hypertension, over 180mmHg systolic blood pressure or 100mmHg in diastolic blood pressure 5. Patients having complications with type 1 diabetes, poorly controlled type 2 diabetes and diabetic retinopathy 6. Patients having complication with severe liver disease 7. Patients having an allergy to milk and soy 8. Patients having complication with mental illness causing a communication difficulty 9. patients having a cardiac pacemaker implantation 10. Patients having a history of hospitalization less than one month before the enrollment 11. Additionally, patients, whose principal researcher determined unfit as a subject for the study
Target sample size	15

Research contact person
Name of lead principal investigator	Yasunori Suzuki
Organization	Kyoto Katsura Hospital
Division name	Department of Nephrology
Address	17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL	075-391-5811
Email	yasunori-suzuki@katsura.com

Public contact
Name of contact person	Yasunori Suzuki
Organization	Kyoto Katsura Hospital
Division name	Dialysis Center
Address	17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL	075-391-5811
Homepage URL
Email	yasunori-suzuki@katsura.com

Sponsor
Institute	Department of Nephrology, Kyoto Katsura 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)

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 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 12 Month 10 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029002