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

• Status: Completed
• Conditions: Kidney Diseases
• Intervention / Treatment: Other: Exercise

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: Observational
• Enrollment (Actual): 267

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Fenix Nefrologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

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?

Number of groups / cohorts

2

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.	Other: Exercise; 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	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	Compare the efficacy of exercise performed during dialysis sessions (intradialytic) versus between sessions (interdialytic).	6 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Lyon College

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: exercise; dialysis; hemodiafiltration
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: 60256122.0.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be stored and only the manuscript results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No