Quality of Life and Sexual Life in Hemodialysis Patients: Effects of an Intradialytic Exercise Program

NCT ID: NCT05836675

Last Updated: 2025-06-26

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2025-06-19

Brief Summary

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The aim of the study is to investigate whether an intradialytic exercise program can improve the quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

Detailed Description

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When diagnosed with Chronic Kidney Disease phase 5, patients are dialyzed to remove waste products and toxins from the blood that kidneys can´t longer filter. Although hemodialysis removes most of the toxins and allows health improvement, patients continue reporting a low quality of life and limitations in their functional independence.

Within the context of quality of life, sexuality is an important factor; a high incidence of sexual dysfunctions has been reported among hemodialysis patients. Although poorly addressed, it impacts family and couple relationships, emotions, and mental health.

Exercise interventions improve physical function and quality of life, and since some of the mechanisms involved in exercise are also involved in sexual activity, an exercise intervention could be an effective approach to sexual dysfunctions without the risk and stigma of sexual or drug therapy.

Therefore the study aims to implement an intradialytic exercise program involving aerobic, resistance, and Kegel exercises (specific to the pelvic floor) and determine its effects on quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

Conditions

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Chronic Kidney Diseases Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

There will be one single group that will act as their own control throughout the intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Since it is an exercise intervention, the participants cannot be masked. When the analysis and interpretation of the data is preformed, the investigator will not know the participants identification data.

Study Groups

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Experimental Intradialytic exercise

Aerobic, resistance and Kegel exercises

Group Type EXPERIMENTAL

Intradialytic exercise

Intervention Type OTHER

The exercise program will be carried out during dialysis time. Participants will be asked to carry out cycling for 15-20 minutes, resistance exercises, and Kegel exercises during the first 2 hours of their regular routine hemodialysis session. Exercise can be done with rest periods as necessary.

Interventions

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Intradialytic exercise

The exercise program will be carried out during dialysis time. Participants will be asked to carry out cycling for 15-20 minutes, resistance exercises, and Kegel exercises during the first 2 hours of their regular routine hemodialysis session. Exercise can be done with rest periods as necessary.

Intervention Type OTHER

Other Intervention Names

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Exercise

Eligibility Criteria

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Inclusion Criteria

* Participants with stage 5 of Chronic Kidney Disease
* Participants that are undergoing hemodialysis for at least 3 months
* Participants between 18 and 70 years old
* Their participation is voluntary and they have signed the informed consent form
* Participants that have medical approval from their nephrologist

Exclusion Criteria

* Participants with severe cardiovascular damage (NYHA \>3)
* Participants with a high probability of receiving a transplant within 6 months
* Participants with psychiatric or psychological disorders such as severe depression (Beck Index) that can affect their ability to consent or participate in the study
* Participants that perform physical exercise at least 2 times a week for the last 3 months or more
* Participants with bilateral lower limb amputation
* Participants with vascular access located in lower limbs
* Pregnant participants
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autónoma de Yucatán

OTHER

Sponsor Role lead

Responsible Party

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Adriana Cruz-Bañares

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Héctor A Rubio-Zapata, Dr

Role: STUDY_DIRECTOR

Universidad Autónoma de Yucatán

Adriana Cruz-Bañares

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma de Yucatán

Locations

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Hospital Regional de Alta Especialidad de la Península de Yucatán

Mérida, Yucatán, Mexico

Site Status

Unidad Médica de Atención Ambulatoria del Instituto Mexicano del Seguro Social

Mérida, Yucatán, Mexico

Site Status

Countries

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Mexico

References

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Salehi F, Mangolian Shahrbabaki P, Dehghan M, Amirihosseini M. Can passive pedaling improve sexual function in patients under hemodialysis? A randomized clinical trial. Ther Apher Dial. 2022 Feb;26(1):130-139. doi: 10.1111/1744-9987.13691. Epub 2021 Jun 11.

Reference Type BACKGROUND
PMID: 34032376 (View on PubMed)

Other Identifiers

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Fmed-05-23

Identifier Type: -

Identifier Source: org_study_id

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