Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration

NCT ID: NCT06448598

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 267 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-12-15

Brief 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. 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.

Conditions

Kidney Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Exercise

Intervention Type: OTHER

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lyon College

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mayron Faria de Oliveira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fenix Nefrologia

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

60256122.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id