UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034855 |
|---|---|
| Receipt number | R000039744 |
| Scientific Title | Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2020/11/20 16:32:04 |
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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)
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
kiyo.0817.piyo@keio.jp
Sponsor or person
Institute
Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039744
