End Stage Renal DiseaseNCT06350552
Prevalence of Postural Abnormalities in Dialysis Patients
An observational study of End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Complication, Peritoneal Dialysis Complication
- How many people
- 395 participants
- Where
- 1 siteIran
- Study dates
- 28 Apr 2024to 3 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The inclusion criteria will be as follows:
- 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.
Who cannot join
- The exclusion criteria will include
- diagnosis of mental or cognitive disorders;
- unstable conditions; and
- hospitalization in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Postural Kyphosis, Postural, Thoracic Kyphosis, Physical Function, Fall, Balance
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through out study completion, an average of 1 weeks
Secondary outcomes (3)
Balance level
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
Measured: Through out study completion, an average of 1 weeks
Cardiopulmonary function's level
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
Measured: Through out study completion, an average of 1 weeks
Fall risk level
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.
Measured: Through out study completion, an average of 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start28 Apr 2024
- Primary completion30 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Tabibi, Dr, Principal investigator, Pardis Specialized Wellness InstituteBobby Cheema, Dr, Study director, School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350552
- Sponsor's protocol ID
- PA224ES-1-03
- Status last verified
- Jun 2024
- First submitted
- 19 Mar 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
Publications
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.
PubMed 21652549Wang 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.
PubMed 32385311Muir 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.
PubMed 19744824Kado 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.
PubMed 15450042Li 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.
PubMed 33367463Charlson 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.
PubMed 3558716Buracchio 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.
PubMed 20697049Padilla 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.
PubMed 18651545Tabibi MA, Salimian N, Nazemi F, Cheema B, Mansourian M, Marateb HR, Shahrbanian S, Ahmadi S, Ahmadi E. Postural abnormalities and functional impairment in hemodialysis and peritoneal dialysis patients: a cross-sectional study. BMC Nephrol. 2026 Jul 3. doi: 10.1186/s12882-026-05180-w. Online ahead of print.
PubMed 42399806
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Prevalence of Hyper Kyphosis and Forward Head Posture in Dialysis Patients
- ClinicalTrials.gov ID
- NCT06350552
- Acronym / sponsor ID
- PA224ES-1-03
- Keywords
- Postural Kyphosis, Postural, Thoracic Kyphosis, Physical Function, Fall, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- The exclusion criteria will include
- diagnosis of mental or cognitive disorders;
- unstable conditions; and
- hospitalization in the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Balance level
Time frame: Through out study completion, an average of 1 weeks
Cardiopulmonary function's level
Time frame: Through out study completion, an average of 1 weeks
Fall risk level
Time frame: Through out study completion, an average of 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Results publication: PubMed 21652549Rossier 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.
- Results publication: PubMed 32385311Wang 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.
- Results publication: PubMed 19744824Muir 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.
- Results publication: PubMed 15450042Kado 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.
- Results publication: PubMed 33367463Li 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.
- Results publication: PubMed 3558716Charlson 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.
- Results publication: PubMed 20697049Buracchio 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.
- Results publication: PubMed 18651545Padilla 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.
- Derived from this study: PubMed 42399806Tabibi MA, Salimian N, Nazemi F, Cheema B, Mansourian M, Marateb HR, Shahrbanian S, Ahmadi S, Ahmadi E. Postural abnormalities and functional impairment in hemodialysis and peritoneal dialysis patients: a cross-sectional study. BMC Nephrol. 2026 Jul 3. doi: 10.1186/s12882-026-05180-w. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Ali Tabibi, Dr principal investigator
Pardis Specialized Wellness Institute
Bobby Cheema, Dr study director
School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of thoracic hyper kyphosis (time frame: Through out study completion, an average of 1 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06350552, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.