UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025214 |
|---|---|
| Receipt number | 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 03:10:33 |
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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
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
yasunori-suzuki@katsura.com
Sponsor or person
Institute
Department of Nephrology, Kyoto Katsura Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029002
