UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050562 |
|---|---|
| Receipt number | R000057588 |
| Scientific Title | Randomized controlled trial on the effectiveness of exercise therapy during dialysis in hemodialysis patients |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2025/02/11 01:47:02 |
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Basic information
Public title
Verification of psychological effects of exercise therapy during dialysis
- Efforts to prevent depression in hemodialysis patients -
Acronym
A study on the effects of exercise during dialysis
Scientific Title
Randomized controlled trial on the effectiveness of exercise therapy during dialysis in hemodialysis patients
Scientific Title:Acronym
Study of exercise during dialysis in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patient
Classification by specialty
| Nephrology | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the usefulness of exercise therapy during dialysis in Japanese hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To confirm the amount of change from baseline in PHQ-9 in the exercise therapy intervention and control groups
Key secondary outcomes
Check the amount of change in SPPB, SEIQOL, serum albumin, BUN, creatinine, sodium concentration, phosphorus concentration, Hb, and potassium concentration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise therapy during dialysis
Interventions/Control_2
No exercise therapy during dialysis
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients who are outpatients at our hospital's dialysis center
Key exclusion criteria
1) Patients for whom exercise therapy is contraindicated or should be avoided by the attending physician
2) History of limb amputation
3) History of femoral neck fracture
4) Complication of dialysis spondylosis
5) Patients whose daily physical activity is significantly reduced, such as requiring a wheelchair for mobility
6) Patients with pathological conditions that may affect the amount of activity, such as markedly reduced daily physical activity (cardiopulmonary complications, ASO, RA, OA, poorly controlled anemia and psychiatric disorders)
7) Other patients who are considered to be excluded by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | hatakenaka |
| Middle name | |
| Last name | yuhei |
Organization
University of the Ryukyus
Division name
Faculty of Humanities and Social Sciences
Zip code
903-0213
Address
1 Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture
TEL
098-895-9053
yuheih@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | ryota |
| Middle name | |
| Last name | tokumoto |
Organization
University of the Ryukyus Graduate School
Division name
Graduate School of Regional Co-Creation
Zip code
903-0213
Address
1 Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture
TEL
070-8444-9207
Homepage URL
k229217@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus Graduate School
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
University of the Ryukyus Graduate School
Address
1 Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture
Tel
098-895-9053
k229217@eve.u-ryukyu.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
| 2023 | 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
30
Results
The QIDS-J score for the intervention group was 5.87 +/- 4.67 at baseline and 3.93 +/- 3.20 after two months, while the non-intervention group was 5.40 +/- 4.61 at baseline and 7.13 +/- 5.99 after two months, showing a tendency for the intervention group's QIDS-J score to decrease.
A comparison after the start of exercise therapy corrected for measurements before the start of exercise therapy revealed a statistically significant difference (P < 0.05).
Results date posted
| 2025 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 04 | Day |
Baseline Characteristics
The subjects were outpatient dialysis patients attending Hospital A who met the following criteria:
1) They have understanding and cooperation with exercise therapy.
2) They are between 60 and 75 years old.
3) They have no history of hospitalization within the past month.
4) Their condition is stable.
5) They have started hemodialysis therapy by the end of March 2023.
On the other hand, the exclusion criteria for subjects were set with reference to the American College of Sports Medicine's guidelines on exercise prescription from the perspective of risk management (American College of Sports Medicine, 2016). Patients who met absolute contraindications for exercise therapy in renal rehabilitation were excluded.
2. Inclusion and Exclusion Criteria for Subjects
1) Inclusion Criteria
The subjects of this study were patients who met all of the following criteria:
They have started hemodialysis therapy by the end of March 2023.
They are between 60 and 75 years old.
They have understanding and cooperation with exercise therapy.
They have no history of hospitalization within the past month.
Hemodialysis is being performed stably and there is no history of psychiatric disorders such as depression.
2) Exclusion criteria
Patients who meet the following criteria were excluded from this study.
Patients for whom exercise therapy is contraindicated or whose doctor judges it should be avoided
Absolute contraindications (American Heart Association):
(a) Acute myocardial infarction within 2 days
(b) Unstable angina that has not been stabilized by medical treatment
(c) Uncontrolled arrhythmia, heart failure, or aortic stenosis
(d) Psychiatric disorders that make communication difficult
(e) Acute aortic dissection or myocarditis
(f) Patients with a history of limb amputation
(g) Patients with a significant decrease in daily physical activity
(h) Other: Patients whose doctor judges them to be excluded (e.g., fractures, dialysis-related spondylosis, etc.)
Participant flow
A total of 104 people were included in the study, but only 34 met the exclusion criteria. Thirty-one of these people agreed to participate in the study, but one was hospitalized and dropped out. The 30 people who ultimately agreed were randomly assigned using Mujinwari (URL: https://mujinwari.biz/users/login) and divided into two groups: the intervention group and the non-intervention group. This study was conducted on a total of 30 people, 15 in the intervention group and 15 in the non-intervention group.
Adverse events
Outcome measures
In this study, the following four items were measured.
1) Psychological indicators
The Japanese version of the Quick Inventory of Depressive Symptomatology (QIDS-J) was used to evaluate psychological status.
2) Physical function
The Short Physical Performance Battery (SPPB) was used to evaluate physical motor function.
3) QOL evaluation
The Schedule for the Evaluation of Individual Quality of Life (SEIQOL) was used to evaluate the quality of life of individuals.
4) Blood data
The following items were measured as blood data.
(a) Serum albumin (ALB)
(b) Urea nitrogen (BUN)
(c) Creatinine (CRE)
(d) Sodium (Na)
(e) Phosphorus (IP)
(f) Potassium (K)
(g) Hemoglobin (Hb)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 11 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057588
