UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046881 |
|---|---|
| Receipt number | R000052958 |
| Scientific Title | Effects of home-based exercise on physical function in older patients with chronic kidney disease |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/02/12 16:56:55 |
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Basic information
Public title
Effects of home-based exercise on physical function in older patients with chronic kidney disease
Acronym
Effects of home-based exercise on physical function in older patients with chronic kidney disease
Scientific Title
Effects of home-based exercise on physical function in older patients with chronic kidney disease
Scientific Title:Acronym
Effects of home-based exercise on physical function in older patients with chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of home-based exercise on physical function after 6 months in older patients with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
grip strength, knee extension strength, 10m walking speed, skeletal muscle mass index (SMI), short physical performance battery(SPPB), 6-min walk test (6MWT)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In the intervention group, a home exercise program will be conducted for 6 months after discharge from the hospital in addition to the educational program for chronic kidney disease patients at our hospital.
The home exercise program will be taught by a physical therapist using materials during the educational hospitalization. The content of the exercise program is based on the Guidelines for Renal Rehabilitation, and the aerobic exercise is walking, and the resistance training is lower limb-centered exercise with body weight. For walking, the number of steps will be recorded using a pedometer owned by the subject or a 3-axis accelerometer to be distributed in advance. Resistance training will consist of squats and calf raises 3 times a week, with 1-3 sets of 10-20 repetitions per set. After the implementation of the exercise program, the patients are instructed to write the number of walking steps and the number of resistance training sessions in the remarks column of the self-management handbook distributed at the time of admission.
After the patient is discharged from the hospital, the home exercise program and the number of exercise sessions will be continued for 6 months. A physiotherapist will provide monthly counseling on the exercise program by telephone. The content of the counseling is to explain the benefits of exercise and physical activity, to motivate the patient to exercise using the results of physical function assessment, to set goals with the patient based on the patient's life and physical function before hospitalization, to listen to factors that inhibit exercise and to plan countermeasures, and to provide feedback on the number of steps taken and the number of exercises performed. The number of steps taken and the number of exercises performed should be fed back.
Interventions/Control_2
The control group will undergo an inpatient education program for chronic kidney disease patients at our hospital for one to two weeks. The educational program will consist of instruction on lifestyle, diet, and medication by a physician, nurse, pharmacist, and nutritionist, as well as an assessment of motor function by a physical therapist and feedback of the results. The physical therapist's evaluation of the patient's motor function and feedback of the results will be conducted only on one day.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with CKD in the conservative stage admitted to Seirei Sakura Shimin Hospital for educational purposes between February 2022 and May 2023
2. Patients with CKD stage G3 - G5 in eGFRcreat. 3.
3. Patients aged 65 years or older
Key exclusion criteria
1. Patients with an eGFRcreat value of 60 ml/min/1.73 m2 or higher in the most recent test results on the measurement date.
2. Patients with poorly controlled hypertension or heart disease
3. Patients with motor or central nervous system diseases that make it difficult to perform physical function assessment.
4. Those who have been diagnosed with dementia.
5. Patients who are not independent in their mobility (less than 6 points in the mobility item of FIM)
6. Those who underwent kidney biopsy during hospitalization.
7. Those who could not give consent for the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | Aki |
| Last name | Tabata |
Organization
Seirei Sakura Citizen Hospital
Division name
Rehabilitation
Zip code
285-8765
Address
2-36-2 Ebaradai, Sakura-shi, Chiba 285-8765, Japan
TEL
+81434861151
tabata4107@gmail.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Tabata |
Organization
Seirei Sakura Citizen Hospital
Division name
Rehabilitation
Zip code
285-8765
Address
2-36-2 Ebaradai, Sakura-shi, Chiba 285-8765, Japan
TEL
09056390507
Homepage URL
tabata4107@gmail.com
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Seirei Christopher University
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
Seirei Christopher University
Address
3453Mikatahara, Kita-ku, Hamamatsu, Shizuoka 433-8558, Japan
Tel
053-439-1400
tabata4107@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
| 2022 | Year | 04 | Month | 01 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2022 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052958
