Prevalence of Postural Abnormalities in Dialysis Patients

June 3, 2024 updated by: Pardis Specialized Wellness Institute

Investigating the Prevalence of Hyper Kyphosis and Forward Head Posture in Dialysis Patients

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

395

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of thoracic hyper kyphosis
Time Frame: Through out study completion, an average of 1 weeks
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
Time Frame: Through out study completion, an average of 1 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance level
Time Frame: Through out study completion, an average of 1 weeks
Timed Up & Go Test (TUG) will be used for balance evaluation. During this test, participants will be required to stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down while the researchers will record the time taken for the entire process. A shorter time taken in this test will be indicative of better dynamic balance. Generally, if a participant completes the test within 10 seconds, it will be considered as having a normal dynamic balance
Through out study completion, an average of 1 weeks
Cardiopulmonary function's level
Time Frame: Through out study completion, an average of 1 weeks
The 6-minute walk test (6MWT) will be frequently utilized as one of the most common walk tests and will be used to assess cardiopulmonary function. The 6MWT will take place on a level, 30-meter-long square within the local community. Participants will be instructed to walk for six minutes to cover as much distance as they can. Prior to the test, the participants' blood pressure and heart rate will be recorded. The researcher will measure the distance walked. An outcome of ≥375 meters suggests that cardiopulmonary function is either near normal or normal, whereas a result of <375 meters suggests impaired cardiopulmonary function
Through out study completion, an average of 1 weeks
Fall risk level
Time Frame: Through out study completion, an average of 1 weeks
Tinetti (ICC > 0.8) Will be used to examine gait dysfunctions and static balance. Patients scoring less than 11 on 12 on the Tinetti test are considered being at an increased risk of falls. The test comprises two short sections that contain one examining static balance abilities in a chair and then standing, and the other gait.
Through out study completion, an average of 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Principal Investigator: Mohammad Ali Tabibi, Dr, Pardis specialized wellness institute
  • Study Director: Bobby Cheema, Dr, School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2024

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

June 3, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA224ES-1-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.

IPD Sharing Time Frame

The data will be available after the paper is published. No end date.

IPD Sharing Access Criteria

Data will be accessible with no criteria. Anyone who wishes will have access to data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe