Chronic Kidney DiseasesNCT06137937
Intradialytic Aerobic Exercise in CKD Patient
A study testing Aerobic Exercise in people with Chronic Kidney Diseases, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients. Read more about this study
- Who is it for?
- Ages 25 to 54 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2023to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.
Read the detailed description
Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Aerobic Exercise
- Keywords
- chronic kidney disease, intradialytic aerobic exercise, physical performance
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Intradialytic aerobic exercise for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program Receives: Behavioral: Aerobic Exercise |
| Control Group | No intervention | subjects in the control group underwent routine hemodialysis without a physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kt/V
Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma Ruslina Defi, Universitas Padjadjaran
- Investigators
- Irma Ruslina Defi, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137937
- Sponsor's protocol ID
- IKFR.10.23
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28838226Yabe 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.
PubMed 34679101
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Aerobic Exercise in CKD Patient
- ClinicalTrials.gov ID
- NCT06137937
- Acronym / sponsor ID
- IKFR.10.23
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, intradialytic aerobic exercise, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.
Detailed description
Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Aerobic Exercisesubjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program |
| Control Group | No intervention | –subjects in the control group underwent routine hemodialysis without a physical exercise program |
Who may qualify
- Ages
- 25 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseIntradialytic aerobic exercise for eight weeks | Behavioural | Interventional Group |
Primary outcome
Kt/V
Time frame: eight weeks
Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 28838226Rhee 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.
- Background: PubMed 34679101Yabe 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.
Related trials for Chronic Kidney Diseases
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma Ruslina Defi principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Chronic Kidney Diseases, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kt/V (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137937, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.