Intradialytic Aerobic Exercise in CKD Patient
1 other identifier
interventional
34
1 country
1
Brief Summary
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2023
CompletedMarch 24, 2025
March 1, 2025
2 months
November 13, 2023
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kt/V
Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention
eight weeks
Study Arms (2)
Interventional Group
EXPERIMENTALsubjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program
Control Group
NO INTERVENTIONsubjects in the control group underwent routine hemodialysis without a physical exercise program
Interventions
Eligibility Criteria
You may qualify if:
- End Stage Renal Disease Patient stage 5 with Glomerular Filtration Rate \<15mL/minute/1.73m2 aged 25-54 years undergoing hemodialysis two times per week for three months to five years
- Hemoglobin levels \> 8mg/dl
- Mini-Mental State Examination (MMSE) score of ≥24
- Hamilton Depression Rating Scale (HDRS) score \<25
You may not qualify if:
- Received aerobic exercise in the last 3 months
- History of hospitalization in the last 3 months
- Access for hemodialysis circulation via the femoral vein.
- IMT \<18,5 (underweight) dan ≥35 (obese class II)
- Non-stable cardiovascular disease, uncontrolled glucose, acute infection disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al Ihsan Hospital
Bandung, West Java, Indonesia
Related Publications (2)
Rhee SY, Song JK, Hong SC, Choi JW, Jeon HJ, Shin DH, Ji EH, Choi EH, Lee J, Kim A, Choi SW, Oh J. Intradialytic exercise improves physical function and reduces intradialytic hypotension and depression in hemodialysis patients. Korean J Intern Med. 2019 May;34(3):588-598. doi: 10.3904/kjim.2017.020. Epub 2017 Aug 25.
PMID: 28838226BACKGROUNDYabe H, Kono K, Yamaguchi T, Ishikawa Y, Yamaguchi Y, Azekura H. Effects of intradialytic exercise for advanced-age patients undergoing hemodialysis: A randomized controlled trial. PLoS One. 2021 Oct 22;16(10):e0257918. doi: 10.1371/journal.pone.0257918. eCollection 2021.
PMID: 34679101BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irma Ruslina Defi
Universitas Padjadjaran
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The sample in this study was determined randomly using a computer; subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2023
First Posted
November 18, 2023
Study Start
November 1, 2023
Primary Completion
December 27, 2023
Study Completion
December 27, 2023
Last Updated
March 24, 2025
Record last verified: 2025-03