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

NCT05836675 | Completed

• 1 other identifier: Fmed-05-23
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Diseases; Sexual Dysfunction

Keywords

Intradialytic exercise; Hemodialysis; Sexual Dysfunctions; Kidney Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (5)

• Depression and anxiety

  6 months

• Body Image Perception

  6 months

• Functional Capacity-6mwt

  6 months

• Functional Capacity-STS30

  6 months

• Functional Capacity-HandgripTest

  6 months

Study Arms (1)

Experimental Intradialytic exercise

EXPERIMENTAL

Aerobic, resistance and Kegel exercises

Other: Intradialytic exercise

Interventions

Intradialytic exercise 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.

Also known as: Exercise

Experimental Intradialytic exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autónoma de Yucatán: lead

Study Sites (2)

Hospital Regional de Alta Especialidad de la Península de Yucatán

Mérida, Yucatán, 97133, Mexico

Location

Unidad Médica de Atención Ambulatoria del Instituto Mexicano del Seguro Social

Mérida, Yucatán, 97217, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34032376 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sexual Dysfunction, Physiological; Kidney Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Héctor A Rubio-Zapata, Dr

  Universidad Autónoma de Yucatán

  STUDY DIRECTOR

• Adriana Cruz-Bañares

  Universidad Autónoma de Yucatán

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: There will be one single group that will act as their own control throughout the intervention

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: August 8, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 19, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)