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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05930964
Other study ID # PA23ES-1-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2023
Est. completion date June 2, 2023

Study information

Verified date November 2023
Source Pardis Specialized Wellness Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Age =18 years - On hemodialysis for =3 months - Able to walk without assistance - Ability to provide informed consent and complete the questionnaires Exclusion Criteria: - Diagnosis of mental or cognitive disorders - Unstable conditions - Hospitalization in the previous 3 months

Study Design


Locations

Country Name City State
Iran, Islamic Republic of Khorshid Dialysis Center Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Pardis Specialized Wellness Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

Bao 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. — View Citation

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. — View Citation

Johansen 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. — View Citation

Johansen 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. — View Citation

Johansen 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. — View Citation

Segura-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 Au — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through out study completion, an average of 1 weeks
Primary Physical Activity Level Physical activity level was assessed by Low Physical Activity Questionnaire (LoPAQ). Through out study completion, an average of 1 weeks
Primary Physical Activity Level Physical activity level was assessed by Community Health Adults Model Program for Seniors (CHAMPS) questionnaire. Through out study completion, an average of 1 weeks
Primary 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). Through out study completion, an average of 2 weeks
Secondary Self-reported physical function level Self-reported physical function was assessed using the Physical Function scale of the Quality of Life questionnaire Through out study completion, an average of 1 weeks
Secondary 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. Through out study completion, an average of 1 weeks
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