Chronic Kidney DiseasesNCT05930964
Validity of Low Physical Activity Questionnaire (LoPAQ)
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 assess validity and reliability of Persian Version of Low Physical Activity Questionnaire. The main questions it mains to answer are: What is the level of physical activity in hemodialysis patients? Is Persian Version of Low Physical Activity Questionnaire, Valid to assess… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, End Stage Renal Disease, Hemodialysis Complication
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 26 Apr 2023to 2 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis 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
- Age ≥18 years
- On hemodialysis for ≥3 months
- Able to walk without assistance
- Ability to provide informed consent and complete the questionnaires
Who cannot join
- Diagnosis of mental or cognitive disorders
- Unstable conditions
- Hospitalization in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Persian Version of Low Physical Activity Questionnaire (LoPAQ)
The goal of this observational study is to assess validity and reliability of Persian Version of Low Physical Activity Questionnaire. The main questions it mains to answer are:
What is the level of physical activity in hemodialysis patients? Is Persian Version of Low Physical Activity Questionnaire, Valid to assess physical activity levels of dialysis patients?
Is Persian Version of Low Physical Activity Questionnaire, reliable?
Participants will answer 3 questionnaires and will do some functional tests.
Read the detailed description
Currently, between 8 and 16 percent of the world's population is suffering from chronic kidney disease, and this number is increasing day by day, and it is predicted that by 2040, kidney disease will be the fifth cause of death.
End-stage kidney disease patients, especially hemodialysis patients, face various problems, and during the years of dialysis, they suffer from many complications and problems, such as repeated hospitalizations, reduced physical performance, reduced aerobic capacity, low quality of life, and having a sedentary life. suffer, so that the activity level of these patients is between 20 and 50% of healthy people.
The physical activity level of patients undergoing hemodialysis treatment is low and significantly lower than the same inactive control groups. Research has shown that the level of physical activity of hemodialysis patients gradually decreases by approximately 4.5% per month during the entire period of the disease . In addition, the activities related to the work done at home constitute the largest part of the energy consumption of hemodialysis patients, which means that the types of activities of hemodialysis patients are usually limited to the lower category.
Valid instruments for measuring physical activity at the low end of the physical activity range and producing quantitative results are required among dialysis patients who are extremely inactive. This study aimed to translate and adapt a Persian version of the low physical activity questionnaire (LoPAQ) and to examine its reliability and validity among hemodialysis patients.
- Keywords
- Hemodialysis, Physical Activity, Validity, Reliability, Sedentary Behaviour
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, 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 3 questionnaires and will do some functional tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content validity of the Low Physical Activity questionnaire
Content validity Content validity of the questionnaire was measured using the content validity index (CVI). The item-level CVI will be calculated as the percentage of specialists giving a rating of either 3 or 4. Generally, a CVI higher than 0.78 suggest good content validity.
Measured: Through out study completion, an average of 1 weeks
Physical Activity Level
Physical activity level was assessed by Low Physical Activity Questionnaire (LoPAQ).
Measured: Through out study completion, an average of 1 weeks
Physical Activity Level
Physical activity level was assessed by Community Health Adults Model Program for Seniors (CHAMPS) questionnaire.
Measured: Through out study completion, an average of 1 weeks
Test-retest reliability of Low Physical Activity Questionnaire (LoPAQ)
Test-retest reliability of Low Physical Activity Questionnaire (LoPAQ) was determined by calculating the intraclass correlation coefficient (ICC,two-way mixed analysis of variance).
Measured: Through out study completion, an average of 2 weeks
Secondary outcomes (2)
Self-reported physical function level
Self-reported physical function was assessed using the Physical Function scale of the Quality of Life questionnaire
Measured: Through out study completion, an average of 1 weeks
Physical performance
Physical performance was assessed using the 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 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 Jul 2023
- Study start26 Apr 2023
- Primary completion24 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 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
- NCT05930964
- Sponsor's protocol ID
- PA23ES-1-02
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data will be available after the paper is published. No end date.
Publications
Huang M, Lv A, Wang J, Xu N, Ma G, Zhai Z, Zhang B, Gao J, Ni C. Exercise Training and Outcomes in Hemodialysis Patients: Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):240-254. doi: 10.1159/000502447. Epub 2019 Aug 27.
PubMed 31454822Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
PubMed 22733312Johansen KL, Chertow GM, Kutner NG, Dalrymple LS, Grimes BA, Kaysen GA. Low level of self-reported physical activity in ambulatory patients new to dialysis. Kidney Int. 2010 Dec;78(11):1164-70. doi: 10.1038/ki.2010.312. Epub 2010 Sep 1.
PubMed 20811334Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.
PubMed 23124787Johansen KL, Painter P, Delgado C, Doyle J. Characterization of physical activity and sitting time among patients on hemodialysis using a new physical activity instrument. J Ren Nutr. 2015 Jan;25(1):25-30. doi: 10.1053/j.jrn.2014.06.012. Epub 2014 Sep 8.
PubMed 25213326Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
PubMed 21719637Tabibi MA, Samouei R, Salimian N, Shahidi S, Atapour A, Nazemi F, Ghenaat M, Nikbakht S, Sarbazi MH, Soleymany M, Roshanaeian Z, Khajeheian B, Khaki Z, Sokani AS, Ebrahimi R, Ahmadi S. Validity and reliability of Persian version of Low Physical Activity Questionnaire (LoPAQ). BMC Nephrol. 2024 May 22;25(1):178. doi: 10.1186/s12882-024-03615-w.
PubMed 38778292
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Persian Version of Low Physical Activity Questionnaire (LoPAQ)
- ClinicalTrials.gov ID
- NCT05930964
- Acronym / sponsor ID
- PA23ES-1-02
- Keywords
- Hemodialysis, Physical Activity, Validity, Reliability, Sedentary Behaviour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 5 Jul 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 assess validity and reliability of Persian Version of Low Physical Activity Questionnaire. The main questions it mains to answer are:
What is the level of physical activity in hemodialysis patients? Is Persian Version of Low Physical Activity Questionnaire, Valid to assess physical activity levels of dialysis patients?
Is Persian Version of Low Physical Activity Questionnaire, reliable?
Participants will answer 3 questionnaires and will do some functional tests.
Detailed description
Currently, between 8 and 16 percent of the world's population is suffering from chronic kidney disease, and this number is increasing day by day, and it is predicted that by 2040, kidney disease will be the fifth cause of death.
End-stage kidney disease patients, especially hemodialysis patients, face various problems, and during the years of dialysis, they suffer from many complications and problems, such as repeated hospitalizations, reduced physical performance, reduced aerobic capacity, low quality of life, and having a sedentary life. suffer, so that the activity level of these patients is between 20 and 50% of healthy people.
The physical activity level of patients undergoing hemodialysis treatment is low and significantly lower than the same inactive control groups. Research has shown that the level of physical activity of hemodialysis patients gradually decreases by approximately 4.5% per month during the entire period of the disease . In addition, the activities related to the work done at home constitute the largest part of the energy consumption of hemodialysis patients, which means that the types of activities of hemodialysis patients are usually limited to the lower category.
Valid instruments for measuring physical activity at the low end of the physical activity range and producing quantitative results are required among dialysis patients who are extremely inactive. This study aimed to translate and adapt a Persian version of the low physical activity questionnaire (LoPAQ) and to examine its reliability and validity among hemodialysis patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | –They will fill 3 questionnaires and will do some functional tests. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis 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 (4 listed)
- Age ≥18 years
- On hemodialysis for ≥3 months
- Able to walk without assistance
- Ability to provide informed consent and complete the questionnaires
Key exclusion criteria (3 listed)
- Diagnosis of mental or cognitive disorders
- Unstable conditions
- 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
Content validity of the Low Physical Activity questionnaire
Time frame: Through out study completion, an average of 1 weeks
Content validity Content validity of the questionnaire was measured using the content validity index (CVI). The item-level CVI will be calculated as the percentage of specialists giving a rating of either 3 or 4. Generally, a CVI higher than 0.78 suggest good content validity.
Physical Activity Level
Time frame: Through out study completion, an average of 1 weeks
Physical activity level was assessed by Low Physical Activity Questionnaire (LoPAQ).
Physical Activity Level
Time frame: Through out study completion, an average of 1 weeks
Physical activity level was assessed by Community Health Adults Model Program for Seniors (CHAMPS) questionnaire.
Test-retest reliability of Low Physical Activity Questionnaire (LoPAQ)
Time frame: Through out study completion, an average of 2 weeks
Test-retest reliability of Low Physical Activity Questionnaire (LoPAQ) was determined by calculating the intraclass correlation coefficient (ICC,two-way mixed analysis of variance).
2 secondary outcomes
Self-reported physical function level
Time frame: Through out study completion, an average of 1 weeks
Physical performance
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 18 Nov 2023.
- Results publication: PubMed 31454822Huang M, Lv A, Wang J, Xu N, Ma G, Zhai Z, Zhang B, Gao J, Ni C. Exercise Training and Outcomes in Hemodialysis Patients: Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):240-254. doi: 10.1159/000502447. Epub 2019 Aug 27.
- Results publication: PubMed 22733312Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
- Results publication: PubMed 20811334Johansen KL, Chertow GM, Kutner NG, Dalrymple LS, Grimes BA, Kaysen GA. Low level of self-reported physical activity in ambulatory patients new to dialysis. Kidney Int. 2010 Dec;78(11):1164-70. doi: 10.1038/ki.2010.312. Epub 2010 Sep 1.
- Results publication: PubMed 23124787Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.
- Results publication: PubMed 25213326Johansen KL, Painter P, Delgado C, Doyle J. Characterization of physical activity and sitting time among patients on hemodialysis using a new physical activity instrument. J Ren Nutr. 2015 Jan;25(1):25-30. doi: 10.1053/j.jrn.2014.06.012. Epub 2014 Sep 8.
- Results publication: PubMed 21719637Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
- Derived from this study: PubMed 38778292Tabibi MA, Samouei R, Salimian N, Shahidi S, Atapour A, Nazemi F, Ghenaat M, Nikbakht S, Sarbazi MH, Soleymany M, Roshanaeian Z, Khajeheian B, Khaki Z, Sokani AS, Ebrahimi R, Ahmadi S. Validity and reliability of Persian version of Low Physical Activity Questionnaire (LoPAQ). BMC Nephrol. 2024 May 22;25(1):178. doi: 10.1186/s12882-024-03615-w.
- Individual participant dataSharing planned: Yes. The data will be available after the paper is published. No end date.
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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 4 inclusion and 3 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 18 Nov 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?
Content validity of the Low Physical Activity questionnaire (time frame: Through out study completion, an average of 1 weeks). The study lists 4 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 NCT05930964, which also lists 7 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 18 Nov 2023.