UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059619 |
|---|---|
| Receipt number | R000067926 |
| Scientific Title | A parallel-group randomized controlled trial on the efficacy of nordic walking exercise Intervention in patients with renal failure prior to initiating dialysis |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/02 10:43:25 |
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Basic information
Public title
A randomized controlled trial investigating the benefits of nordic walking exercise therapy for patients with chronic kidney disease approaching dialysis Initiation
Acronym
A study on exercise therapy for renal failure using nordic walking
Scientific Title
A parallel-group randomized controlled trial on the efficacy of nordic walking exercise Intervention in patients with renal failure prior to initiating dialysis
Scientific Title:Acronym
NORDIC-CKD
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates exercise tolerance in pre-dialysis patients (7<eGFR<20 mL/min/1.73 m2) receiving care at our hospital using cardiopulmonary exercise testing (CPX). Participants will then be randomly assigned to a Nordic walking (NW) intervention group or a control group. Comparisons will be made between baseline and three months, as well as between the two groups, to examine the effects of NW on exercise tolerance in patients with advanced chronic kidney disease approaching dialysis initiation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
All patients attending the outpatient clinic of the Department of Nephrology, Japanese Red Cross Medical Center, with an eGFR between 7 and 20 mL/min/1.73 m2 who meet the inclusion criteria will be recruited. The exercise intervention period will last for 12 weeks from the baseline assessment, with follow-up evaluations conducted at 12 weeks. The primary endpoints will be the CPX parameters: peak VO2 (peak oxygen uptake), AT (anaerobic threshold), and VE vs VCO2 slope (ventilatory efficiency slope).
Key secondary outcomes
The secondary outcome measures will include handgrip strength, appendicular skeletal muscle mass (measured using a body composition analyzer, Tanita MC-780MA-N, Tanita Corp., Tokyo, Japan), body composition (Tanita MC-780MA-N), chronic kidney disease (CKD)-related laboratory outcomes (Ca, P, intact PTH, TC, HDL, TG, Hb, Alb, HbA1c), and health-related quality of life (HR-QOL).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The exercise intensity of Nordic Walking (NW) will be determined based on the exercise tolerance evaluated by a cardiopulmonary exercise test (CPX). In addition, the Rating of Perceived Exertion (RPE; Borg scale, range 6-20) will be used, and participants will be instructed to exercise at an intensity corresponding to a Borg score of 11-13 (somewhat hard).According to the CPX results, NW will be recommended at a frequency of three to five times per week, once per day, for 30-60 minutes per session. To monitor adherence, participants in the intervention group will be provided with postcards at the start of the study and asked to record the duration of each NW session and the corresponding Borg score, and to mail the postcards every two weeks. For ongoing support, participants will be encouraged during outpatient visits, and feedback will be provided to help them improve their NW technique or adjust exercise intensity as needed.
Interventions/Control_2
Usual physical activity
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 attending the outpatient clinic of the Department of Nephrology at the Japanese Red Cross Medical Center who meet the criterion of renal function with an estimated glomerular filtration rate (eGFR) between 7 and 20 mL/min/1.73 m2 will be included. The lower limit of renal function was determined with reference to the IDEAL study (Cooper BA et al, N Engl J Med 2010; 363:609-619).
Key exclusion criteria
1 Patients contraindicated for exercise therapy (specifically the following):
Uncontrolled hypertension (persistent systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg)
Severe anemia (Hb < 7 g/dL)
Active proliferative diabetic retinopathy
Individuals who developed symptomatic coronary artery disease or cerebrovascular disease within the past 3 months
Uncontrolled heart failure (NYHA Class III or higher)
Severe or life-threatening arrhythmias with significant symptoms
Severe valvular heart disease
Individuals with difficulty walking due to orthopedic conditions, cerebrovascular disease, peripheral arterial disease, etc.
2 Patients with unstable systemic conditions (specifically the following):
Uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L, HCO3 < 18 mmol/L)
3 Other patients deemed unsuitable as subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sonoda |
| Middle name | Sumura |
| Last name | Rena |
Organization
Tokyo University of Science
Division name
Department of Advanced Bioethics and Medical Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JAPAN
TEL
080-4634-4172
r.sumura1118@gmail.com
Public contact
Name of contact person
| 1st name | Sonoda |
| Middle name | Sumura |
| Last name | Rena |
Organization
Tokyo University of Science
Division name
Department of Advanced Bioethics and Medical Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JAPAN
TEL
080-4634-4172
Homepage URL
r.sumura1118@gmail.com
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Science
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
Japanese Red Cross Medical Center
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo 150-8935, JAPAN
Tel
03-3400-1311
r.sumura1118@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
1705
Org. issuing International ID_1
Japanese Red Cross Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067926
