NCT05930964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

28 days

First QC Date

June 14, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

HemodialysisPhysical ActivityValidityReliabilitySedentary Behaviour

Outcome Measures

Primary Outcomes (4)

  • 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

  • Physical Activity Level

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

    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.

    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).

    Through out study completion, an average of 2 weeks

Secondary Outcomes (2)

  • Self-reported physical function level

    Through out study completion, an average of 1 weeks

  • Physical performance

    Through out study completion, an average of 1 weeks

Study Arms (1)

Hemodialysis patients

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age ≥18 years
  • On hemodialysis for ≥3 months
  • Able to walk without assistance
  • Ability to provide informed consent and complete the questionnaires

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khorshid Dialysis Center

Isfahan, Iran

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Tabibi 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.

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicMotor Activity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • MohammadAli Tabibi, PhD

    Pardis Specialized Wellness Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 5, 2023

Study Start

April 26, 2023

Primary Completion

May 24, 2023

Study Completion

June 2, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The data will be available after the paper is published. No end date.

Shared Documents
SAP
Time Frame
The data will be available after the paper is published. No end date.
Access Criteria
Data will be accessible with no criteria. Anyone who wishes will have access to data.

Locations