Clinical trial NCT05743998: Inactivity and Quality of Life in Dialysis Patients
Official title: Inactivity and Health Related Quality of Life in Dialysis Patients and Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
End Stage Renal Disease
Hemodialysis Complication
Peritoneal Dialysis
Keywords: Inactivity
Quality of life
Physical activity
Sedentary lifestyle
Peritoneal Dialysis
Hemodialysis
Exercise
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodialysis and peritoneal dialysis patients being treated with the same respective dialysis modalities for at least 3 months and being ambulatory (with or without assistive device) will be included.

But non-ambulatory patients having significant cognitive dysfunction, progressive degenerative,neurologic disease or severe rheumatologic or orthopedic conditions, angina upon exertion, or myocardial infarction or cardiac surgery within the last year will be excluded.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life level
timeFrame: Through out study completion, an average of 2 weeks
measure: Physical activity level
timeFrame: Through out study completion, an average of 2 weeks
Secondary outcomes:
measure: Physical functioning level
timeFrame: Through out study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Dialysis Center
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: MohammadAli Tabibi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramer SJ, McCall NN, Robinson-Cohen C, Siew ED, Salat H, Bian A, Stewart TG, El-Sourady MH, Karlekar M, Lipworth L, Ikizler TA, Abdel-Kader K. Health Outcome Priorities of Older Adults with Advanced CKD and Concordance with Their Nephrology Providers' Perceptions. J Am Soc Nephrol. 2018 Dec;29(12):2870-2878. doi: 10.1681/ASN.2018060657. Epub 2018 Nov 1.
citation: DeOreo PB. Hemodialysis patient-assessed functional health status predicts continued survival, hospitalization, and dialysis-attendance compliance. Am J Kidney Dis. 1997 Aug;30(2):204-12. doi: 10.1016/s0272-6386(97)90053-6.
citation: Painter P, Roshanravan B. The association of physical activity and physical function with clinical outcomes in adults with chronic kidney disease. Curr Opin Nephrol Hypertens. 2013 Nov;22(6):615-23. doi: 10.1097/MNH.0b013e328365b43a.
citation: Luk WS. Rehabilitation services for patients undergoing peritoneal dialysis in Hong Kong. Nurs Stand. 2006 Jan 25-31;20(20):41-7. doi: 10.7748/ns2006.01.20.20.41.c4049.
citation: Ulutas O, Farragher J, Chiu E, Cook WL, Jassal SV. Functional Disability in Older Adults Maintained on Peritoneal Dialysis Therapy. Perit Dial Int. 2016 Jan-Feb;36(1):71-8. doi: 10.3747/pdi.2013.00293. Epub 2014 Apr 7.
citation: Roshanravan B, Robinson-Cohen C, Patel KV, Ayers E, Littman AJ, de Boer IH, Ikizler TA, Himmelfarb J, Katzel LI, Kestenbaum B, Seliger S. Association between physical performance and all-cause mortality in CKD. J Am Soc Nephrol. 2013 Apr;24(5):822-30. doi: 10.1681/ASN.2012070702. Epub 2013 Apr 18.