Clinical trial NCT06350552: Prevalence of Postural Abnormalities in Dialysis Patients
Official title: Investigating the Prevalence of Hyper Kyphosis and Forward Head Posture in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Hemodialysis Complication
Peritoneal Dialysis Complication
Keywords: Postural Kyphosis
Postural, Thoracic Kyphosis
Physical Function
Fall
Balance
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 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.

Detailed description: Given the global rise in fall rates and associated medical costs in the past decade, it is crucial to identify factors that contribute to fall risk in order to mitigate the occurrence of falls and reduce their adverse consequences.

One significant factor that increases the likelihood of falls is the presence of a balance disorder. The Forward head posture (FHP) can adversely affect one's static balance. FHP characterized by the bending forward of the lower cervical spine and the bending backward of the upper cervical spine. The prevalence of FHP rises as one gets older and has been associated with an elevated risk of falls, altered limits of stability, and changes in the musculoskeletal structures of the cervical spine. FHP can significantly impact respiratory function by weakening the muscles involved in breathing.

Alterations in the positioning of the center of gravity can have a detrimental impact on the control of body balance . Balance can also be affected by thoracic hyper kyphosis, which refers to an excessive curvature of the thoracic spine. When compensation in the lumbar spine and hip region is insufficient, hyper kyphosis may shift the body's center of mass forward, leading to gait disorders and disrupted balance.

Changes in posture, like thoracic hyper kyphosis and loss of lumbar lordosis arch seem to contribute to the increased postural instability and leading to a greater likelihood of falls among older adults living in the community. Hyper kyphosis may act as an indicator of an elevated risk of falls. Internationally, thoracic hyper kyphosis has a high prevalence, and studies have shown that it is associated with impaired performance in balance, gait, and cardiopulmonary function tests among older adults.

The likelihood of hyper kyphosis and FHP, followed by increased falls in elderly individuals and women, is attributed to factors such as reduced physical activity, lower bone density, weaker muscles, and decreased overall body strength . Considering the presence of these conditions in dialysis patients, it is likely that these patients are also at an increased risk of kyphosis and FHP, and consequently, they face the risk of falls.

The study of postural abnormalities in patients undergoing hemodialysis (HD) and peritoneal dialysis (PD) makes it possible to identify prevention and safety promotion strategies for individuals with chronic kidney disease. Thus, the objectives of this study are to identify the prevalence of forward head and hyper kyphosis as well as their adverse outcomes in people with chronic kidney disease undergoing two dialysis modalities.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria will be as follows:

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

Exclusion Criteria:

The exclusion criteria will include

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

Primary outcomes:
measure: Prevalence of thoracic hyper kyphosis
timeFrame: Through out study completion, an average of 1 weeks
measure: Prevalence of forward head
timeFrame: Through out study completion, an average of 1 weeks
Secondary outcomes:
measure: Balance level
timeFrame: Through out study completion, an average of 1 weeks
measure: Cardiopulmonary function's level
timeFrame: Through out study completion, an average of 1 weeks
measure: Fall risk level
timeFrame: Through out study completion, an average of 1 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Dialysis Center
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: Mohammad Ali Tabibi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
name: Bobby Cheema, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.