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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025214
Receipt No. R000029002
Scientific Title Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia: a randomized parallel-group pilot study
Date of disclosure of the study information 2016/12/10
Last modified on 2017/11/30

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Basic information
Public title Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia: a randomized parallel-group pilot study
Acronym Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia
Scientific Title Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia: a randomized parallel-group pilot study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasunori Suzuki
Organization Kyoto Katsura Hospital
Division name Department of Nephrology
Zip code
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
1st name
Middle name
Last name Yasunori Suzuki
Organization Kyoto Katsura Hospital
Division name Dialysis Center
Zip code
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)

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
2016 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
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

Other
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

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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