Inactivity and Quality of Life in Dialysis Patients

NCT ID: NCT05743998

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-03-22

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases End Stage Renal Disease Hemodialysis Complication Peritoneal Dialysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis patients

They will fill 2 questionnaires and ill do some functional tests.

No interventions assigned to this group

Peritoneal dialysis patients

They will fill 2 questionnaires and ill do some functional tests.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pardis Specialized Wellness Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MohammadAli Tabibi, PhD

Role: PRINCIPAL_INVESTIGATOR

Pardis Specialized Wellness Institute

Locations

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Khorshid Dialysis Center

Isfahan, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 30385652 (View on PubMed)

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.

Reference Type RESULT
PMID: 9261030 (View on PubMed)

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.

Reference Type RESULT
PMID: 24100215 (View on PubMed)

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.

Reference Type RESULT
PMID: 16459764 (View on PubMed)

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.

Reference Type RESULT
PMID: 24711642 (View on PubMed)

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.

Reference Type RESULT
PMID: 23599380 (View on PubMed)

Other Identifiers

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PA23ES-1-01

Identifier Type: -

Identifier Source: org_study_id

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