UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034651 |
|---|---|
| Receipt number | R000039029 |
| Scientific Title | Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/11/06 13:27:38 |
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Basic information
Public title
Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Acronym
Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer
Scientific Title
Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Scientific Title:Acronym
Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer
Region
| Japan |
Condition
Condition
Chronic kidney disease, hemodialysis
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The resistance training intervention for 3months is performed for hemodialysis patients undergoing long-term intradialytic ergometer exercise in this study. The effect of combined use of aerobic exercise and resistance training on hemodialysis patients undergoing long-term ergometer exercise intervention is verified by comparing the evaluation of the physical function before and after combination with resistance training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Gait function before 3-months, before starting and after 3-months of exercise intervention.
Key secondary outcomes
Muscle strength, balance ability, and body composition before 3-months, before starting and after 3-months of exercise intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The subjects who are performing supine-position ergometer exercise during dialysis for more than 6 months add in low intensity resistance training before dialysis in this study. The resistance training covers the upper limb and lower limb muscles which can be easily performed by sitting position and standing position and should be voluntary training. The method of resistance exercise is shown graphic display, and at the time of introduction, practical instruction is given by a physical therapist (PT). In accordance with the cardiac rehabilitation guideline, we will teach the subjects to perform the exercise from 10 to 15 times as 1 set, and 2 to 3 sets in accordance with the individual's degree of fatigue. When exercise cannot be done, ask the reasons why it cannot be done, and re-instruct if there are problems concerning implementation.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The hemodialysis patients who currently undergoing ergometer exercise during dialysis or currently do not exercise but want exercise. Currently, patients between 40 and 81 years old are carrying out.
Key exclusion criteria
The patients who have not been approved by doctor about performing the resistance training or who have systolic blood pressure above 200 mmHg before exercise.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Noguchi |
Organization
Konjo University
Division name
Faculty of Medical Health
Zip code
924-8511
Address
1200,kasama-cho,hakusan City, Ishikawa ,Japan
TEL
076-276-4400
noguchi@kinjo.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Tanaka |
Organization
Mizuho hospital
Division name
Rehabilitation
Zip code
929-0346
Address
422-1,katabata,tsubata-cho,kahoku-gun, Ishikawa ,Japan
TEL
076-255-3008
Homepage URL
mizuho@tiara.ocn.ne.jp
Sponsor or person
Institute
Mizuho 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
Mizuho Hospital
Address
422-1,katabata,tsubata-cho,kahoku-gun, Ishikawa ,Japan
Tel
076-255-3008
mizuho@tiara.ocn.ne.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 | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1589/jpts.34.110
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1589/jpts.34.110
Number of participants that the trial has enrolled
23
Results
6MD results were significantly improved after the additional combined intervention compared to before the additional combined intervention (p<0.05).
As a result of multiple regression analysis, only the average distance traveled was employed 6MD related as the independent variable.
Results date posted
| 2023 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 23 | Day |
Baseline Characteristics
Participants were 23 outpatients (21 males and 2 females) receiving hemodialysis at the Mizuho Hospital Dialysis Center.
All participants maintained mobility and had the ability to commute to the hospital on their own.
Participant flow
Participants were selected from 132 outpatients receiving hemodialysis at the Mizuho Hospital Dialysis Center, 23 of whom were outpatients who volunteered to participate in the intervention study on dialysis and exercise.
This study had (A) period of only supine ergometer exercise during dialysis and (B) period of additional combined intervention of supine ergometer exercise during dialysis plus resistance exercise before dialysis. A period was longer than 3 months, and most of the participants had been performing supine ergometer exercise during dialysis for years prior to the A period and had a long exercise history. The B period was set at 12 weeks. We compared the changes in physical function data over time at three assessment times: before and after the A and B periods.
Five participants withdrew during the B period, and 18 participants (16 males and 2 females) completed this study. Three of the participants had a prolonged B period due to restrictions caused by coronavirus infection. However, since studies of patients undergoing hemodialysis often set up suspension periods and account for dropouts, we examined the effect of including the suspension period in this study in the intention-to-treat analysis.
Adverse events
No adverse events were observed in this study.
Outcome measures
Measurements of physical function included grip strength, knee-extension muscle strength, one-leg standing time, timed up-and-go test (TUG), and 6-min walk distance test (6MD).
We recorded the number of days the supine ergometer exercise was implemented during the A period, and that for both the resistance training and supine ergometer exercises during the B period. Additionally, the driving distance of the supine ergometer during the A and B periods was recorded each time, and the average driving distance and total driving distance during the A and B periods were calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 02 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039029
