Kidney DiseasesNCT06448598
Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration
An observational study of Kidney Diseases, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Patients with chronic kidney disease suffer from uremic toxin accumulation. Treatments with hemodiafiltration demonstrate the highest capacity for removing solutes, as well as improving mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Exercise
- How many people
- 267 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 15 Dec 2023
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included patients with end-stage renal disease (ESRD/CKD stage 5D) undergoing maintenance hemodiafiltration (HDF) at the Fenix Nephrology Group between 2021 and 2023.
Who may be able to join
- 18 years or older
- Undergoing maintenance hemodiafiltration (HDF)
- Optimized medication regimen
- Agreed to participate in the exercise program with at least 80% adherence
Who cannot join
- Patients who underwent kidney transplantation during the study period
- Patients with missing data
- Patients with exercise participation below 80% adherence
- Presence of comorbidities such as COPD, stroke, muscle weakness, or recent orthopedic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration: A 6- Month Analysis
Patients with chronic kidney disease suffer from uremic toxin accumulation. Treatments with hemodiafiltration demonstrate the highest capacity for removing solutes, as well as improving mortality. While exercise has been proven as an adjunct therapy in patients on maintenance hemodialysis, little is known about the exercise influence in maintenance hemodiafiltration programs.
Methods: A retrospective observational study of chronic kidney disease patients at Fenix Nephrology group from 2021 until 2023. Patients were assessed at the start of the exercise program and after six months of rehabilitation. Physical tests included a step-test for endurance, handgrip and one-repetition maximum for muscle strength. The Kidney Disease Quality of Life Short Form evaluated patient-reported outcomes. Kt/V urea and urea reduction ratio were surrogates for hemodiafiltration adequacy. Patients carried out twice weekly aerobic exercises at 70% of the maximum heart rate during the step test, and resistance exercises at 60% of one-repetition maximum.
Read the detailed description
The objectives of this study were twofold: first, to understand if hemodiafiltration (HDF) combined with exercise is a safe and effective treatment for patients with end-stage renal disease (ESRD/CKD 5D); and second, to explore the efficacy of exercise performed during dialysis sessions (intradialytic) versus between sessions (interdialytic).
The study employed a retrospective observational design, analyzing data from CKD 5D patients undergoing maintenance HDF at the Fenix Nephrology group between 2021 and 2023. Inclusion criteria stipulated that participants were aged 18 years or older, on HDF with optimized medication, and agreed to participate in the exercise program with at least 80% adherence. Assessments were conducted at baseline and after six months of rehabilitation, including a step-test for endurance, handgrip strength measurement, one-repetition maximum (1RM) test for muscle strength, and the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. Kt/V and urea reduction ratio (URR) were used as surrogates for HDF adequacy.
The exercise protocol involved twice-weekly sessions, with aerobic exercises performed at 70% of the maximum heart rate achieved during the step test, and resistance exercises at 60% of 1RM. Participants self-selected their exercise timing, either intradialytic (during HDF sessions) or interdialytic (on non-dialysis days). For the intradialytic group, exercise was seamlessly integrated into the HDF session, excluding the initial and final two hours of dialysis.
- Conditions
- Kidney Diseases
- Being tested
- Exercise
- Keywords
- hemodiafiltration, dialysis, exercise
- Medical subject headings
- Kidney Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercise protocol involved twice-weekly sessions, with aerobic exercises performed at 70% of the maximum heart rate achieved during the step test, and resistance exercises at 60% of 1RM. Participants self-selected their exercise timing, either intradialytic (during HDF sessions) or interdialytic (on non-dialysis days). For the intradialytic group, exercise was seamlessly integrated into the HDF session, excluding the initial and final two hours of dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | he exercise group consisted of patients who participated in the exercise program, which involved twice-weekly sessions of aerobic exercises performed at 70% of maximum heart rate from a step test, as well as resistance exercises at 60% of one-repetition maximum strength. Within the exercise group, participants self-selected into either the intradialytic subgroup, where exercise was performed during their hemodiafiltration (HDF) sessions, or the interdialytic subgroup, where exercise took place on non-dialysis days. Receives: Other: Exercise | |
| Control | The control group did not undergo any exercise intervention or physical evaluations with a physical therapist. Data collected from the control group pertained solely to dialysis adequacy measures such as Kt/V and urea reduction ratio (URR). This allowed for comparisons between the exercise and non-exercise groups in terms of dialysis efficiency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Intervention
Determine if hemodiafiltration (HDF) combined with exercise is a safe and effective treatment for patients with end-stage renal disease compared to controls.
Measured: 6 months
Secondary outcomes (1)
Inter- and intra-dialysis exercise intervention
Compare the efficacy of exercise performed during dialysis sessions (intradialytic) versus between sessions (interdialytic).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Feb 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Lyon College
- Responsible party
- Principal investigator, Mayron Faria de Oliveira, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448598
- Sponsor's protocol ID
- 60256122.0.0000.5505
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be stored and only the manuscript results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration: A 6- Month Analysis
- ClinicalTrials.gov ID
- NCT06448598
- Acronym / sponsor ID
- 60256122.0.0000.5505
- Conditions
- Kidney Diseases
- Keywords
- hemodiafiltration, dialysis, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Lyon College
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 7 Jun 2024 (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.
Patients with chronic kidney disease suffer from uremic toxin accumulation. Treatments with hemodiafiltration demonstrate the highest capacity for removing solutes, as well as improving mortality. While exercise has been proven as an adjunct therapy in patients on maintenance hemodialysis, little is known about the exercise influence in maintenance hemodiafiltration programs.
Methods: A retrospective observational study of chronic kidney disease patients at Fenix Nephrology group from 2021 until 2023. Patients were assessed at the start of the exercise program and after six months of rehabilitation. Physical tests included a step-test for endurance, handgrip and one-repetition maximum for muscle strength. The Kidney Disease Quality of Life Short Form evaluated patient-reported outcomes. Kt/V urea and urea reduction ratio were surrogates for hemodiafiltration adequacy. Patients carried out twice weekly aerobic exercises at 70% of the maximum heart rate during the step test, and resistance exercises at 60% of one-repetition maximum.
Detailed description
The objectives of this study were twofold: first, to understand if hemodiafiltration (HDF) combined with exercise is a safe and effective treatment for patients with end-stage renal disease (ESRD/CKD 5D); and second, to explore the efficacy of exercise performed during dialysis sessions (intradialytic) versus between sessions (interdialytic).
The study employed a retrospective observational design, analyzing data from CKD 5D patients undergoing maintenance HDF at the Fenix Nephrology group between 2021 and 2023. Inclusion criteria stipulated that participants were aged 18 years or older, on HDF with optimized medication, and agreed to participate in the exercise program with at least 80% adherence. Assessments were conducted at baseline and after six months of rehabilitation, including a step-test for endurance, handgrip strength measurement, one-repetition maximum (1RM) test for muscle strength, and the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. Kt/V and urea reduction ratio (URR) were used as surrogates for HDF adequacy.
The exercise protocol involved twice-weekly sessions, with aerobic exercises performed at 70% of the maximum heart rate achieved during the step test, and resistance exercises at 60% of 1RM. Participants self-selected their exercise timing, either intradialytic (during HDF sessions) or interdialytic (on non-dialysis days). For the intradialytic group, exercise was seamlessly integrated into the HDF session, excluding the initial and final two hours of dialysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | – | Other: Exercisehe exercise group consisted of patients who participated in the exercise program, which involved twice-weekly sessions of aerobic exercises performed at 70% of maximum heart rate from a step test, as well as resistance exercises at 60% of one-repetition maximum strength. Within the exercise group, participants self-selected into either the intradialytic subgroup, where exercise was performed during their hemodiafiltration (HDF) sessions, or the interdialytic subgroup, where exercise took place on non-dialysis days. |
| Control | – | –The control group did not undergo any exercise intervention or physical evaluations with a physical therapist. Data collected from the control group pertained solely to dialysis adequacy measures such as Kt/V and urea reduction ratio (URR). This allowed for comparisons between the exercise and non-exercise groups in terms of dialysis efficiency. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients with end-stage renal disease (ESRD/CKD stage 5D) undergoing maintenance hemodiafiltration (HDF) at the Fenix Nephrology Group between 2021 and 2023.
Key inclusion criteria (4 listed)
- 18 years or older
- Undergoing maintenance hemodiafiltration (HDF)
- Optimized medication regimen
- Agreed to participate in the exercise program with at least 80% adherence
Key exclusion criteria (4 listed)
- Patients who underwent kidney transplantation during the study period
- Patients with missing data
- Patients with exercise participation below 80% adherence
- Presence of comorbidities such as COPD, stroke, muscle weakness, or recent orthopedic surgery.
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 |
|---|---|---|
| ExerciseThe exercise protocol involved twice-weekly sessions, with aerobic exercises performed at 70% of the maximum heart rate achieved during the step test, and resistance exercises at 60% of 1RM. Participants self-selected their exercise timing, either intradialytic (during HDF sessions) or interdialytic (on non-dialysis days). For the intradialytic group, exercise was seamlessly integrated into the HDF session, excluding the initial and final two hours of dialysis. | Other | Exercise |
Primary outcome
Exercise Intervention
Time frame: 6 months
Determine if hemodiafiltration (HDF) combined with exercise is a safe and effective treatment for patients with end-stage renal disease compared to controls.
1 secondary outcome
Inter- and intra-dialysis exercise intervention
Time frame: 6 months
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 10 Jun 2024.
- Individual participant dataSharing planned: No. All data will be stored and only the manuscript results will be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by Federal University of São Paulo at 1 site in Brazil.
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 4 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 10 Jun 2024. 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 Brazil. 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?
Exercise Intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.