NCT06137937

Brief Summary

Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

November 13, 2023

Last Update Submit

March 19, 2025

Conditions

Keywords

chronic kidney diseaseintradialytic aerobic exercisephysical performance

Outcome Measures

Primary Outcomes (1)

  • Kt/V

    Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention

    eight weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program

Behavioral: Aerobic Exercise

Control Group

NO INTERVENTION

subjects in the control group underwent routine hemodialysis without a physical exercise program

Interventions

Intradialytic aerobic exercise for eight weeks

Interventional Group

Eligibility Criteria

Age25 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • End Stage Renal Disease Patient stage 5 with Glomerular Filtration Rate \<15mL/minute/1.73m2 aged 25-54 years undergoing hemodialysis two times per week for three months to five years
  • Hemoglobin levels \> 8mg/dl
  • Mini-Mental State Examination (MMSE) score of ≥24
  • Hamilton Depression Rating Scale (HDRS) score \<25

You may not qualify if:

  • Received aerobic exercise in the last 3 months
  • History of hospitalization in the last 3 months
  • Access for hemodialysis circulation via the femoral vein.
  • IMT \<18,5 (underweight) dan ≥35 (obese class II)
  • Non-stable cardiovascular disease, uncontrolled glucose, acute infection disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ihsan Hospital

Bandung, West Java, Indonesia

Location

Related Publications (2)

  • Rhee SY, Song JK, Hong SC, Choi JW, Jeon HJ, Shin DH, Ji EH, Choi EH, Lee J, Kim A, Choi SW, Oh J. Intradialytic exercise improves physical function and reduces intradialytic hypotension and depression in hemodialysis patients. Korean J Intern Med. 2019 May;34(3):588-598. doi: 10.3904/kjim.2017.020. Epub 2017 Aug 25.

    PMID: 28838226BACKGROUND
  • Yabe H, Kono K, Yamaguchi T, Ishikawa Y, Yamaguchi Y, Azekura H. Effects of intradialytic exercise for advanced-age patients undergoing hemodialysis: A randomized controlled trial. PLoS One. 2021 Oct 22;16(10):e0257918. doi: 10.1371/journal.pone.0257918. eCollection 2021.

    PMID: 34679101BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Irma Ruslina Defi

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The sample in this study was determined randomly using a computer; subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

November 1, 2023

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations