Prevalence of Postural Abnormalities in Dialysis Patients

NCT06350552 | Completed DMC

• 1 other identifier: PA224ES-1-03
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are: What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients? Participants will answer 2 questionnaires and will do some functional tests.

Conditions

End Stage Renal Disease; Hemodialysis Complication; Peritoneal Dialysis Complication

Keywords

Postural Kyphosis; Postural, Thoracic Kyphosis; Physical Function; Fall; Balance

Outcome Measures

Primary Outcomes (2)

• Prevalence of thoracic hyper kyphosis

  Thoracic hyper kyphosis using the flexicurve approach, the procedure will involve utilizing a 60 cm flexible ruler (Trident®), millimeter paper, adhesive tape, pen, and a specific formula will be documented in Microsoft Excel.

  Through out study completion, an average of 1 weeks

• Prevalence of forward head

  The digital imaging technique (knee registry application) will be utilized to assess head and neck posture in a standing position. A mobile device will be positioned 150 cm away on a tripod stand, adjusting the height to align with the subject's shoulder level. The subject will be directed to face the camera straight on and then to the side. A photo will be captured and saved in jpg format using the knee registry application. A line will be drawn from the spinous process to the tragus of the ear, and the angle will subsequently be measured. The craniovertebral angle will often be employed as a diagnostic tool for identifying forward head.

  Through out study completion, an average of 1 weeks

Secondary Outcomes (3)

• Balance level

  Through out study completion, an average of 1 weeks

• Cardiopulmonary function's level

  Through out study completion, an average of 1 weeks

• Fall risk level

  Through out study completion, an average of 1 weeks

Study Arms (2)

Hemodialysis

They will be assessed for postural abnormalities. Also, they will do some physical function tests.

Peritoneal Dialysis

They will be assessed for postural abnormalities. Also, they will do some physical function tests.

Eligibility Criteria

• Age: 18 Years - 80 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:

• age ≥18 years;
• on dialysis for ≥3 months;
• able to walk without assistance (walking device such as cane or walker allowed); and
• ability to provide informed consent and complete the questionnaires.

You may not qualify if:

• diagnosis of mental or cognitive disorders;
• unstable conditions; and
• hospitalization in the previous 3 months.

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Khorshid Dialysis Center

Isfahan, Iran

Location

Related Publications (8)

• Rossier A, Pruijm M, Hannane D, Burnier M, Teta D. Incidence, complications and risk factors for severe falls in patients on maintenance haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):352-7. doi: 10.1093/ndt/gfr326. Epub 2011 Jun 7.

  PMID: 21652549 RESULT

• Wang HH, Wu JL, Lee YC, Ho LC, Chang MY, Liou HH, Hung SY. Risk of Serious Falls Between Hemodialysis and Peritoneal Dialysis Patients: A Nationwide Population-based Cohort Study. Sci Rep. 2020 May 8;10(1):7799. doi: 10.1038/s41598-020-64698-7.

  PMID: 32385311 RESULT

• Muir SW, Berg K, Chesworth B, Klar N, Speechley M. Quantifying the magnitude of risk for balance impairment on falls in community-dwelling older adults: a systematic review and meta-analysis. J Clin Epidemiol. 2010 Apr;63(4):389-406. doi: 10.1016/j.jclinepi.2009.06.010. Epub 2009 Sep 9.

  PMID: 19744824 RESULT

• Kado DM, Huang MH, Karlamangla AS, Barrett-Connor E, Greendale GA. Hyperkyphotic posture predicts mortality in older community-dwelling men and women: a prospective study. J Am Geriatr Soc. 2004 Oct;52(10):1662-7. doi: 10.1111/j.1532-5415.2004.52458.x.

  PMID: 15450042 RESULT

• Li WY, Chau PH, Dai Y, Tiwari AF. The Prevalence and Negative Effects of Thoracic Hyperkyphosis on Chinese Community-Dwelling Older Adults in Wuhan, Hubei Province, China. J Nutr Health Aging. 2021;25(1):57-63. doi: 10.1007/s12603-020-1441-1.

  PMID: 33367463 RESULT

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 RESULT

• Buracchio T, Dodge HH, Howieson D, Wasserman D, Kaye J. The trajectory of gait speed preceding mild cognitive impairment. Arch Neurol. 2010 Aug;67(8):980-6. doi: 10.1001/archneurol.2010.159.

  PMID: 20697049 RESULT

• Padilla J, Krasnoff J, Da Silva M, Hsu CY, Frassetto L, Johansen KL, Painter P. Physical functioning in patients with chronic kidney disease. J Nephrol. 2008 Jul-Aug;21(4):550-9.

  PMID: 18651545 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

• Bobby Cheema, Dr

  School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 5, 2024
• Study Start: April 28, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 3, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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)