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Chronic Kidney DiseasesNCT05836675

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

A study testing Intradialytic exercise in people with Chronic Kidney Diseases and Sexual Dysfunction, run by Universidad Autónoma de Yucatán at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Kidney Diseases, Sexual Dysfunction
What is being tested?
Intradialytic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesMexico
Study dates
8 Aug 2023to 19 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Hospital Regional de Alta Especialidad de la Península de Yucatán

    Mérida, Yucatán, 97133

  • Unidad Médica de Atención Ambulatoria del Instituto Mexicano del Seguro Social

    Mérida, Yucatán, 97217

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
Intradialytic exercise
Keywords
Intradialytic exercise, Hemodialysis, Sexual Dysfunctions, Kidney Disease
Medical subject headings
Renal Insufficiency, Chronic, Sexual Dysfunction, Physiological, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradialytic exerciseOther

    Also called 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.

Study groups in NCT05836675
Study groupRoleWhat they receive
Experimental Intradialytic exerciseExperimentalAerobic, resistance and Kegel exercises
Receives: Other: Intradialytic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kidney Disease and Quality of life

    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.

    Measured: 6 months

  2. Sexual Function

    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.

    Measured: 6 months

  3. Sexual Satisfaction

    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.

    Measured: 6 months

Secondary outcomes (5)

  1. Depression and anxiety

    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.

    Measured: 6 months

  2. Body Image Perception

    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.

    Measured: 6 months

  3. Functional Capacity-6mwt

    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.

    Measured: 6 months

  4. Functional Capacity-STS30

    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.

    Measured: 6 months

  5. Functional Capacity-HandgripTest

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start8 Aug 2023
  3. Primary completion30 Apr 2024
  4. Study completion19 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
There will be one single group that will act as their own control throughout the intervention
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836675
Sponsor's protocol ID
Fmed-05-23
Status last verified
Jun 2025
First submitted
19 Apr 2023
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34032376

Questions about this trial

What is this clinical trial studying?

A study testing Intradialytic exercise in people with Chronic Kidney Diseases and Sexual Dysfunction, run by Universidad Autónoma de Yucatán at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kidney Disease and Quality of life (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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