NCT07507981

Brief Summary

Objective: To evaluate the effects of a six-month intradialytic aerobic exercise program on left ventricular ejection fraction in patients with end-stage kidney disease undergoing maintenance hemodialysis. Materials and Methods Design: Open-label, single-center, quasi-experimental, single-group study with pre- and post-intervention measurements. Study setting: the outpatient hemodialysis unit of the National Institute of Medical Sciences and Nutrition Salvador Zubirán. Participants: Patients aged ≥18 years with chronic kidney disease on hemodialysis for at least three months, who are at their dry weight. Procedures: An echocardiogram will be performed post-hemodialysis. Subsequently, patients will undergo a 30-minute intradialytic aerobic exercise program at submaximal intensity during the second hour of dialysis, three times per week for six months. At the end of the six-month period, a post-hemodialysis echocardiogram will be repeated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

March 23, 2026

Last Update Submit

March 30, 2026

Conditions

Keywords

Intradialytic ExerciseHemodialysisEnd Stage Cronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    Left ventricular ejection fraction measured by transthoracic echocardiogram

    From study enrollment to the initiation of the exercise program (within a maximum of 6 weeks), and subsequently from completion of the exercise program to up to 6 weeks thereafter

Study Arms (1)

Patients on hemodialysis who will perform intradialytic aerobic exercise

EXPERIMENTAL

Patients on hemodialysis who will perform intradialytic aerobic exercise for six months

Other: Intradialytic aerobic exercise program

Interventions

A six-month intradialytic aerobic exercise program consisting of 30-minute sessions at submaximal intensity, performed during the second hour of hemodialysis three times per week.

Patients on hemodialysis who will perform intradialytic aerobic exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years
  • Receiving hemodialysis with a stable prescription for at least 3 months
  • At their prescribed dry weight
  • Provision of written informed consent

You may not qualify if:

  • Active cardiovascular disease within the past 3 months
  • Left ventricular ejection fraction \<40%
  • Physical and/or cognitive impairment precluding exercise
  • Blood pressure \>160/110 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 2, 2026

Study Start

May 1, 2025

Primary Completion

February 28, 2026

Study Completion

March 15, 2026

Last Updated

April 2, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared in order to protect patient privacy and confidentiality and to comply with institutional and ethical regulations.

Locations