Inactivity and Quality of Life in Dialysis Patients

NCT05743998 | Completed DMC

• 1 other identifier: PA23ES-1-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Quality of life level

  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

  Through out study completion, an average of 2 weeks

• Physical activity level

  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.

  Through out study completion, an average of 2 weeks

Secondary Outcomes (1)

• Physical functioning level

  Through out study completion, an average of 2 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Khorshid Dialysis Center

Isfahan, Iran

Location

Related Publications (6)

• 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.

  PMID: 30385652 RESULT

• 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.

  PMID: 9261030 RESULT

• 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.

  PMID: 24100215 RESULT

• 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.

  PMID: 16459764 RESULT

• 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.

  PMID: 24711642 RESULT

• 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.

  PMID: 23599380 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• MohammadAli Tabibi, PhD

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 24, 2023
• Study Start: February 28, 2023
• Primary Completion: March 20, 2023
• Study Completion: March 22, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the paper is published. No end date.
• Access Criteria: Data will be accessible with no criteria. Anyone who wishes will have access to data.

Locations

IR (1)