Inactivity and Quality of Life in Dialysis Patients

Sponsor

Pardis Specialized Wellness Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05743998

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Days)

243.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:

What is the level of physical activity in hemodialysis and peritoneal dialysis patients?
What is the level of quality of life of hemodialysis and peritoneal dialysis patients?
Is there any relation between inactivity and quality of life in hemodialysis and peritoneal dialysis patients?

Participants will answer 2 questionnaires and will do some functional tests.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases End Stage Renal Disease Hemodialysis Complication Peritoneal Dialysis

Detailed Description

Physical functioning and physical activity are low in patients treated with maintenance hemodialysis (HD).

One of the factors that lead to a further decrease in the activity of hemodialysis patients and its complications is the immobility of these patients during hemodialysis. This method of treatment forces patients to remain motionless for 4 hours on average 3 times a week. In addition, fatigue after dialysis also requires additional rest and immobility for about 2 to 6 hours.

Sedentary behaviors are also common in peritoneal dialysis (PD) patients (about 63%), and studies have shown that there is no significant difference between the physical activity level of PD and HD patients.

In PD patients, in addition to reducing functional capacity and feeling extreme fatigue, the fear of dialysis fluid leakage, hernia and infection also causes a decrease in physical activity and an increase in inactivity in these patients.

The lack of physical mobility and the resulting movement restrictions affect the patient's independence and ability to perform daily tasks, including self-care. In addition, the emotional and mental health of patients is greatly affected by these restrictions Inactivity sets off a vicious cycle in which energy imbalances can increase comorbidities such as hypertension, diabetes, coronary artery disease, depressive disorders, hospitalization rates, and disability. Each of these conditions aggravates the decrease in the quality of life and increases the mortality of patients.

Quality of life is an important aspect of treatment outcomes and should be considered when evaluating the quality and effectiveness of renal care services.

The quality of life in CKD patients and especially dialysis patients decreases under the influence of several factors such as weakness, disability, reduced functional capacity, anemia, malnutrition, impaired cognitive function, worsening sleep quality, increased depression, and the development of cardiovascular disorders The quality of life of renal patients and its social and emotional aspects are considered as the main determinants of these clinical outcomes.

Decreasing the quality of life in hemodialysis patients and peritoneal dialysis patients decreases the survival and increases the mortality of these patients. Improving the quality of life should not only be considered as a therapeutic goal in itself, but should also be considered as an essential factor in reducing the number of hospitalizations and deaths of dialysis patients.

This study aims to evaluate the quality of life of HD patients as well as PD patients. Also this study will evaluate the effect of inactivity on quality of life, stratified by both dialysis modality and will compere the results in these two dialysis modalities.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Inactivity and Health Related Quality of Life in Dialysis Patients and Peritoneal Dialysis Patients

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hemodialysis patients They will fill 2 questionnaires and ill do some functional tests.
Peritoneal dialysis patients They will fill 2 questionnaires and ill do some functional tests.

Outcome Measures

Primary Outcome Measures

Quality of life level [Through out study completion, an average of 2 weeks]
Quality of life will be assessed by health related quality of life questionnaire for chronic kidney disease patients Higher scores indicate higher levels of quality of life
Physical activity level [Through out study completion, an average of 2 weeks]
Physical activity level will be assessed by Low Physical activity questionnaire (LoPAQ) This questionnaire assesses the levels of physical activity and will be explained by calories expenditure. Those who are less active will have lower calories expenditure.

Secondary Outcome Measures

Physical functioning level [Through out study completion, an average of 2 weeks]
Physical functioning level will be assessed by short physical performance battery test. The range of this test score is 0-12. Those who have disabilities in the activity of their daily living will take lower scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

being treated with the same respective dialysis modalities for at least 3 months
being ambulatory (with or without assistive device)
ability to understand and provide informed consent

Exclusion Criteria:

non-ambulatory
had significant cognitive dysfunction
progressive degenerative
neurologic disease
severe rheumatologic or orthopedic conditions that would limit and would be exacerbated by the testing
angina upon exertion, or myocardial infarction or cardiac surgery within the last year.