Chronic Kidney DiseasesNCT05743998
Inactivity and Quality of Life in Dialysis Patients
An observational study of Chronic Kidney Diseases and End Stage Renal Disease, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Kidney Diseases, End Stage Renal Disease, Hemodialysis Complication
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 28 Feb 2023to 22 Mar 2023
- 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 95 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inactivity and Health Related Quality of Life in Dialysis Patients and Peritoneal Dialysis Patients
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.
Read the detailed description
Physical functioning and physical activity are low in patients treated with maintenance hemodialysis (HD).
One of the factors that lead to a further decrease in the activity of hemodialysis patients and its complications is the immobility of these patients during hemodialysis. This method of treatment forces patients to remain motionless for 4 hours on average 3 times a week. In addition, fatigue after dialysis also requires additional rest and immobility for about 2 to 6 hours.
Sedentary behaviors are also common in peritoneal dialysis (PD) patients (about 63%), and studies have shown that there is no significant difference between the physical activity level of PD and HD patients.
In PD patients, in addition to reducing functional capacity and feeling extreme fatigue, the fear of dialysis fluid leakage, hernia and infection also causes a decrease in physical activity and an increase in inactivity in these patients.
The lack of physical mobility and the resulting movement restrictions affect the patient's independence and ability to perform daily tasks, including self-care. In addition, the emotional and mental health of patients is greatly affected by these restrictions Inactivity sets off a vicious cycle in which energy imbalances can increase comorbidities such as hypertension, diabetes, coronary artery disease, depressive disorders, hospitalization rates, and disability. Each of these conditions aggravates the decrease in the quality of life and increases the mortality of patients.
Quality of life is an important aspect of treatment outcomes and should be considered when evaluating the quality and effectiveness of renal care services.
The quality of life in CKD patients and especially dialysis patients decreases under the influence of several factors such as weakness, disability, reduced functional capacity, anemia, malnutrition, impaired cognitive function, worsening sleep quality, increased depression, and the development of cardiovascular disorders The quality of life of renal patients and its social and emotional aspects are considered as the main determinants of these clinical outcomes.
Decreasing the quality of life in hemodialysis patients and peritoneal dialysis patients decreases the survival and increases the mortality of these patients. Improving the quality of life should not only be considered as a therapeutic goal in itself, but should also be considered as an essential factor in reducing the number of hospitalizations and deaths of dialysis patients.
This study aims to evaluate the quality of life of HD patients as well as PD patients. Also this study will evaluate the effect of inactivity on quality of life, stratified by both dialysis modality and will compere the results in these two dialysis modalities.
- 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
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Sedentary Behavior, Motor Activity
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Through out study completion, an average of 2 weeks
Secondary outcomes (1)
Physical functioning level
Physical functioning level will be assessed by short physical performance battery test.
The range of this test score is 0-12. Those who have disabilities in the activity of their daily living will take lower scores.
Measured: Through out study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start28 Feb 2023
- Primary completion20 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MohammadAli Tabibi, PhD, Principal investigator, Pardis Specialized Wellness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743998
- Sponsor's protocol ID
- PA23ES-1-01
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
Publications
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.
PubMed 30385652DeOreo 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.
PubMed 9261030Painter 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.
PubMed 24100215Luk 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.
PubMed 16459764Ulutas 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.
PubMed 24711642Roshanravan 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.
PubMed 23599380
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inactivity and Health Related Quality of Life in Dialysis Patients and Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT05743998
- Acronym / sponsor ID
- PA23ES-1-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 24 Feb 2023 (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 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.
Detailed description
Physical functioning and physical activity are low in patients treated with maintenance hemodialysis (HD).
One of the factors that lead to a further decrease in the activity of hemodialysis patients and its complications is the immobility of these patients during hemodialysis. This method of treatment forces patients to remain motionless for 4 hours on average 3 times a week. In addition, fatigue after dialysis also requires additional rest and immobility for about 2 to 6 hours.
Sedentary behaviors are also common in peritoneal dialysis (PD) patients (about 63%), and studies have shown that there is no significant difference between the physical activity level of PD and HD patients.
In PD patients, in addition to reducing functional capacity and feeling extreme fatigue, the fear of dialysis fluid leakage, hernia and infection also causes a decrease in physical activity and an increase in inactivity in these patients.
The lack of physical mobility and the resulting movement restrictions affect the patient's independence and ability to perform daily tasks, including self-care. In addition, the emotional and mental health of patients is greatly affected by these restrictions Inactivity sets off a vicious cycle in which energy imbalances can increase comorbidities such as hypertension, diabetes, coronary artery disease, depressive disorders, hospitalization rates, and disability. Each of these conditions aggravates the decrease in the quality of life and increases the mortality of patients.
Quality of life is an important aspect of treatment outcomes and should be considered when evaluating the quality and effectiveness of renal care services.
The quality of life in CKD patients and especially dialysis patients decreases under the influence of several factors such as weakness, disability, reduced functional capacity, anemia, malnutrition, impaired cognitive function, worsening sleep quality, increased depression, and the development of cardiovascular disorders The quality of life of renal patients and its social and emotional aspects are considered as the main determinants of these clinical outcomes.
Decreasing the quality of life in hemodialysis patients and peritoneal dialysis patients decreases the survival and increases the mortality of these patients. Improving the quality of life should not only be considered as a therapeutic goal in itself, but should also be considered as an essential factor in reducing the number of hospitalizations and deaths of dialysis patients.
This study aims to evaluate the quality of life of HD patients as well as PD patients. Also this study will evaluate the effect of inactivity on quality of life, stratified by both dialysis modality and will compere the results in these two dialysis modalities.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 95 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 (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
Quality of life level
Time frame: Through out study completion, an average of 2 weeks
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
Physical activity level
Time frame: Through out study completion, an average of 2 weeks
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.
1 secondary outcome
Physical functioning level
Time frame: Through out study completion, an average of 2 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 27 Mar 2023.
- Results publication: PubMed 30385652Ramer 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.
- Results publication: PubMed 9261030DeOreo 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.
- Results publication: PubMed 24100215Painter 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.
- Results publication: PubMed 16459764Luk 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.
- Results publication: PubMed 24711642Ulutas 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.
- Results publication: PubMed 23599380Roshanravan 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.
- 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.
MohammadAli Tabibi, PhD principal investigator
Pardis Specialized Wellness Institute
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 Chronic Kidney Diseases and End Stage Renal Disease, 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 3 inclusion and 6 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 27 Mar 2023. 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?
Quality of life level (time frame: Through out study completion, an average of 2 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 NCT05743998, which also lists 6 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 27 Mar 2023.