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

Primary Purpose

Chronic Kidney Diseases, Sexual Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Intradialytic exercise
Sponsored by
Universidad Autónoma de Yucatán
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Intradialytic exercise, Hemodialysis, Sexual Dysfunctions, Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Regional de Alta Especialidad de la Península de Yucatán

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Intradialytic exercise

Arm Description

Aerobic, resistance and Kegel exercises

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 19, 2023
Last Updated
May 30, 2023
Sponsor
Universidad Autónoma de Yucatán
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1. Study Identification

Unique Protocol Identification Number
NCT05836675
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autónoma de Yucatán

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Sexual Dysfunction
Keywords
Intradialytic exercise, Hemodialysis, Sexual Dysfunctions, Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There will be one single group that will act as their own control throughout the intervention
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intradialytic exercise
Arm Type
Experimental
Arm Description
Aerobic, resistance and Kegel exercises
Intervention Type
Other
Intervention Name(s)
Intradialytic exercise
Other Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kidney Disease and Quality of life
Description
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.
Time Frame
6 months
Title
Sexual Function
Description
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.
Time Frame
6 months
Title
Sexual Satisfaction
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression and anxiety
Description
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.
Time Frame
6 months
Title
Body Image Perception
Description
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.
Time Frame
6 months
Title
Functional Capacity-6mwt
Description
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.
Time Frame
6 months
Title
Functional Capacity-STS30
Description
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.
Time Frame
6 months
Title
Functional Capacity-HandgripTest
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Cruz-Bañares, MSc
Phone
+524491074143
Email
adriana.cruz.banares@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Héctor A Rubio-Zapata, Dr
Email
hector.rubio@correo.uady.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Héctor A Rubio-Zapata, Dr
Organizational Affiliation
Universidad Autónoma de Yucatán
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adriana Cruz-Bañares
Organizational Affiliation
Universidad Autónoma de Yucatán
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad de la Península de Yucatán
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97133
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan P Flores-Tapia, Dr
Email
uromid@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34032376
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.
Results Reference
result

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

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