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CompletedNCT05930964Updated Nov 18, 2023

Validity of Low Physical Activity Questionnaire (LoPAQ)

An observational study in Chronic Kidney Diseases, End Stage Renal Disease and Hemodialysis Complication, sponsored by Pardis Specialized Wellness Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Pardis Specialized Wellness Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Chronic Kidney Diseases
  • End Stage Renal Disease
  • Hemodialysis Complication

Keywords

  • Hemodialysis
  • Physical Activity
  • Validity
  • Reliability
  • Sedentary Behaviour
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 100 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Pardis Specialized Wellness Institute is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Diagnosis of mental or cognitive disorders
  • Unstable conditions
  • Hospitalization in the previous 3 months
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Hemodialysis patients

    They will fill 3 questionnaires and will do some functional tests.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through out study completion, an average of 1 weeks

  2. Physical Activity Level

    Physical activity level was assessed by Low Physical Activity Questionnaire (LoPAQ).

    Time frame: Through out study completion, an average of 1 weeks

  3. Physical Activity Level

    Physical activity level was assessed by Community Health Adults Model Program for Seniors (CHAMPS) questionnaire.

    Time frame: Through out study completion, an average of 1 weeks

  4. 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).

    Time frame: Through out study completion, an average of 2 weeks

Secondary outcomes

  1. Self-reported physical function level

    Self-reported physical function was assessed using the Physical Function scale of the Quality of Life questionnaire

    Time frame: Through out study completion, an average of 1 weeks

  2. 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.

    Time frame: Through out study completion, an average of 1 weeks

07

Study locations

1 site
  • Khorshid Dialysis Center
    Isfahan, Iran, Islamic Republic of
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References and documents

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 31454822 ↗
  • 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. PubMed 22733312 ↗
  • 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. PubMed 20811334 ↗
  • 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. PubMed 23124787 ↗
  • 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. Erratum In: J Ren Nutr. 2015 Jul;25(4):397. PubMed 25213326 ↗
  • 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. PubMed 21719637 ↗

Individual participant data

Plan to share: Yes — The data will be available after the paper is published. No end date.

Supporting information: Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05930964
Lead sponsor
Pardis Specialized Wellness Institute
Responsible party
Sponsor
First posted
Jul 5, 2023
Start date
Apr 26, 2023
Primary completion
May 24, 2023
Completion
Jun 2, 2023
Last update
Nov 18, 2023

Study contacts

MohammadAli Tabibi, PhD
principal investigator · Pardis Specialized Wellness Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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