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

June 20, 2025 updated by: Adriana Cruz-Bañares, Universidad Autónoma de Yucatán

Effects of an Intradialytic Exercise Program on Quality of Life, Sexual Function, and Sexual Satisfaction of Patients Undergoing Hemodialysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97133
        • Hospital Regional de Alta Especialidad de la Península de Yucatán
      • Mérida, Yucatán, Mexico, 97217
        • Unidad Médica de Atención Ambulatoria del Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Intradialytic exercise
Aerobic, resistance and Kegel exercises
Other: 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.
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kidney Disease and Quality of life
Time Frame: 6 months
This outcome will be measured by means of the Kidney Disease and Quality of life Questionnaire (KDQOL-SF36) which is a specific questionnaire designed for patients with kidney disease on dialysis; it was developed by the Kidney Disease Quality of life Working Group as a self-report measure of health-related quality of life perceived by patients with this condition. It is a self-reported questionnaire that includes generic items for chronic conditions (SF-36) and disease-specific items. The minimum score is 0 and the maximum score is 100; a higher score means a better quality of life.
6 months
Sexual Function
Time Frame: 6 months

For men, the outcome will be measured by means of the International Index of Erectile Function (IIEF) which is a questionnaire designed to evaluate erectile dysfunction. It was developed with the aim of assessing the effects of the Sildenafil clinical trial and is now the gold standard measure for erectile dysfunction. It is a self-reported questionnaire that includes 15 questions regarding erectile function, orgasm function, sexual arousal and satisfaction. The minimum score is 5 and the maximum score is 75; a higher score means less dysfunction while a lower one means a more severe dysfunction.

For women, the outcome will be measured by means of the Female Sexual Function Index (FSFI) which is a questionnaire designed to assess female sexual function. It is a self-reported inventory with 19 questions addressing desire, arousal, lubrication, orgasm, satisfaction and pain. An score under 26 expresses the presence of a dysfunction.
6 months
Sexual Satisfaction
Time Frame: 6 months
This outcome will be measured by means of the New Sexual Satisfaction Scale (NSSS) which is a questionnaire designed to measure global sexual satisfaction regardless gender, sexual orientation or relationship status. It is a self-reported questionnaire that includes 20 questions regarding sexual sensations, sexual awareness, sexual exchange, emotional connection and sexual activity. The maximum score is 100; a higher score means a better perception of their sexual satisfaction.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression and anxiety
Time Frame: 6 months
This will be measured by means of the Beck Depression and Anxiety Scale. It is a sef-reported questionnaire that assesses the clinical symptoms present in depression, it is commonly used to assess the severity of the disease. It consists in 21 questions that ask about how the individual has felt in the past 2 weeks. The minimum score is 0 and the maximum one is 63; a highest score means a more severe depression.
6 months
Body Image Perception
Time Frame: 6 months
This outcome will be measured by means of a Body Image Perception Questionnaire designed to assess the level of body image disturbance in patients undergoing dialysis or with kidney transplant. It is a self-reported questionnaire with 20 questions with a minimum of 0 points and a maximum of 80; a higher score means a more severe body image disturbance.
6 months
Functional Capacity-6mwt
Time Frame: 6 months
The functional capacity will be measured by means of the 6-minute-walk-test (6mwt) which is defined as a constant load stress test that measures the distance the participant can walk in a period of 6 minutes, at a fast pace and with possible resting breaks. The test is widely used in chronic kidney disease patients and reflects the functional ability to perform daily activities.
6 months
Functional Capacity-STS30
Time Frame: 6 months
The functional capacity will also be measured by means of the sit-to-stand test (STS30) which assesses the lower limb function by asking the participant to sit and stand as fast as possible as many times in 30 seconds.
6 months
Functional Capacity-HandgripTest
Time Frame: 6 months
The functional capacity will also be measured by means of the Handgrip Test which assesses the upper limb muscle strength by performing a dynamometry. The participant will squizz the grip until they reach their maximum strength for 2 seconds, the test will be performed twice.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autónoma de Yucatán

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Héctor A Rubio-Zapata, Dr, Universidad Autonoma de Yucatan
  • Principal Investigator: Adriana Cruz-Bañares, Universidad Autonoma de Yucatan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fmed-05-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Intradialytic exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings