Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration

NCT06448598 | Completed

• 1 other identifier: 60256122.0.0000.5505
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

hemodiafiltration; dialysis; exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inter- and intra-dialysis exercise intervention

  6 months

Study Arms (2)

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

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.

Interventions

Exercise 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.

Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• Undergoing maintenance hemodiafiltration (HDF)
• Optimized medication regimen
• Agreed to participate in the exercise program with at least 80% adherence

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Lyon College: collaborator

Study Sites (1)

Fenix Nefrologia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Kidney Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: February 1, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)