Clinical trial NCT05930964: Validity of Low Physical Activity Questionnaire (LoPAQ)
Official title: Validity and Reliability of Persian Version of Low Physical Activity Questionnaire (LoPAQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
End Stage Renal Disease
Hemodialysis Complication
Keywords: Hemodialysis
Physical Activity
Validity
Reliability
Sedentary Behaviour
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Content validity of the Low Physical Activity questionnaire
timeFrame: Through out study completion, an average of 1 weeks
measure: Physical Activity Level
timeFrame: Through out study completion, an average of 1 weeks
measure: Physical Activity Level
timeFrame: Through out study completion, an average of 1 weeks
measure: Test-retest reliability of Low Physical Activity Questionnaire (LoPAQ)
timeFrame: Through out study completion, an average of 2 weeks
Secondary outcomes:
measure: Self-reported physical function level
timeFrame: Through out study completion, an average of 1 weeks
measure: Physical performance
timeFrame: Through out study completion, an average of 1 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Dialysis Center
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: MohammadAli Tabibi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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: 10.2215/CJN.08560812. Epub 2012 Nov 2.
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.
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 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.