Clinical trial NCT05836675: Quality of Life and Sexual Life in Hemodialysis Patients: Effects of an Intradialytic Exercise Program
Official title: Effects of an Intradialytic Exercise Program on Quality of Life, Sexual Function, and Sexual Satisfaction of Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Sexual Dysfunction
Keywords: Intradialytic exercise
Hemodialysis
Sexual Dysfunctions
Kidney Disease
Lead sponsor: Universidad Autónoma de Yucatán
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be one single group that will act as their own control throughout the intervention
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kidney Disease and Quality of life
timeFrame: 6 months
measure: Sexual Function
timeFrame: 6 months
measure: Sexual Satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: Depression and anxiety
timeFrame: 6 months
measure: Body Image Perception
timeFrame: 6 months
measure: Functional Capacity-6mwt
timeFrame: 6 months
measure: Functional Capacity-STS30
timeFrame: 6 months
measure: Functional Capacity-HandgripTest
timeFrame: 6 months
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Hospital Regional de Alta Especialidad de la Península de Yucatán
state: Yucatán
city: Mérida
country: Mexico
facility: Unidad Médica de Atención Ambulatoria del Instituto Mexicano del Seguro Social
state: Yucatán
Study officials:
affiliation: Universidad Autónoma de Yucatán
name: Héctor A Rubio-Zapata, Dr
role: STUDY_DIRECTOR
affiliation: Universidad Autónoma de Yucatán
name: Adriana Cruz-Bañares
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.