- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448598
Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Fenix Nefrologia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- Undergoing maintenance hemodiafiltration (HDF)
- Optimized medication regimen
- Agreed to participate in the exercise program with at least 80% adherence
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter- and intra-dialysis exercise intervention
Time Frame: 6 months
|
Compare the efficacy of exercise performed during dialysis sessions (intradialytic) versus between sessions (interdialytic).
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60256122.0.0000.5505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.