Intradialytic Aerobic Exercise in CKD Patient

NCT ID: NCT06137937

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2023-12-27

Brief Summary

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

Detailed Description

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Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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Interventional Group

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

Intradialytic aerobic exercise for eight weeks

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

Intradialytic aerobic exercise for eight weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Irma Ruslina Defi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irma Ruslina Defi

Role: PRINCIPAL_INVESTIGATOR

Universitas Padjadjaran

Locations

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Al Ihsan Hospital

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 28838226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34679101 (View on PubMed)

Other Identifiers

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IKFR.10.23

Identifier Type: -

Identifier Source: org_study_id

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