UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052466 |
|---|---|
| Receipt number | R000059839 |
| Scientific Title | The Effect of Nordic Walking for Improving Walking Ability in Patients with Peritoneal Dialysis : a Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2023/10/11 16:33:46 |
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Basic information
Public title
The Effect of Nordic Walking for Improving Walking Ability in Patients with Peritoneal Dialysis : a Randomized Controlled Trial
Acronym
The Effect of Nordic Walking in Peritoneal Dialysis Patients
Scientific Title
The Effect of Nordic Walking for Improving Walking Ability in Patients with Peritoneal Dialysis : a Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Nordic Walking in Peritoneal Dialysis Patients
Region
| Japan |
Condition
Condition
Patients with peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess the effect of Nordic walking in patients with peritoneal dialysis who meet the criteria of sarcopenia (including possible sarcopenia) or have pain of their locomotor in this trial. Primary outcome is six-minute walk test as an index of aerobic capacity and secondary outcome is evaluation score of sarcopenia such as walking speed, grip strength, and skeletal mass index.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six-minute walk test as an index of aerobic capacity in 12 weeks after assignment.
Key secondary outcomes
Evaluation factors of sarcopenia (walking speed, grip strength, and skeletal mass index), ABI/PWV, body composition index, CKD-related parameters (serum Na/K/Cl, Ca/P/PTH intact, UA, TC/HDL/TG, Hb, carnitine), residual kidney function, Numerical Rate Scale of locomotor, evaluated 12 weeks after assignment.
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nordic walking for 20-30 minutes more than three times a week. Exercise intensity is decided by two points. One is Borg Scale, of which target score is 11-13. The other is pulse rate of 20-30 bpm higher than at rest. For the beginning of this trial, we guide 15-minute-Nordic walking after warming up more than three times a week, then 4 weeks later patients are guided 20-30 minute-Nordic walking more than three times a week.
Interventions/Control_2
Ordinary 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
1) Outpatients with peritoneal dialysis
2) Patients who meet the criteria of sarcopenia(defined by walking speed, grip strength, and skeletal mass index).
3) Patients who have pains of locomotor.
4) Patients from whom we can obtain informed consent.
Key exclusion criteria
1)Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases.
2) Unstable PD patients. Concrete criteria are as follows: patients who undergo PD less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L).
3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ishibashi |
| Middle name | |
| Last name | Yoshitaka |
Organization
Japanese Red Cross Medical Center
Division name
DIvision of Nephorology
Zip code
150-8935
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
yi431204@gmail.com
Public contact
Name of contact person
| 1st name | Sumura |
| Middle name | |
| Last name | Rena |
Organization
Japanese Red Cross Medical Center
Division name
DIvision of Nephorology
Zip code
150-8935
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
Homepage URL
r.sumura1118@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
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
Japanese Red Cross Medical Center
Address
Japanese Red Cross Medical Center
Tel
03-3400-1311
r.sumura1118@gmail.com
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
| 2023 | Year | 10 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059839
