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Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism

4. November 2026 aktualisiert von: Andijan State Medical Institute

Psychometric Validation of the Uzbek-Language SARC-F and IPAQ-SF Among Adults With and Without Primary Hypothyroidism

This study aims to evaluate the reliability and validity of two Uzbek-language questionnaires in adults with and without primary hypothyroidism (an underactive thyroid).

The SARC-F questionnaire asks about difficulties with everyday physical activities, such as walking, standing up from a chair, and climbing stairs. It helps identify people who may need further assessment for sarcopenia, a condition involving reduced muscle strength and function. The International Physical Activity Questionnaire-Short Form (IPAQ-SF) assesses walking, moderate and vigorous physical activity, and sitting time during the previous seven days.

The study will include 480 Uzbek-speaking adults aged 18 years or older in the Andijan region of Uzbekistan. Of these, 240 will have primary hypothyroidism and 240 will have normal thyroid function. Both women and men will participate.

All participants will complete both questionnaires and undergo measurements of muscle strength and physical function. At least 200 participants will complete the same questionnaires again after 7-14 days.

The researchers will examine how consistently the questionnaires measure physical function and activity and how their results relate to objective functional measurements. No experimental treatment will be provided.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

This prospective observational methodological study is designed to evaluate the measurement properties of the Uzbek-language SARC-F and International Physical Activity Questionnaire-Short Form (IPAQ-SF) among adults with and without primary hypothyroidism.

SARC-F assesses self-reported functional limitations relevant to sarcopenia screening, whereas IPAQ-SF measures self-reported physical activity. Although these instruments assess complementary aspects of physical health, they represent distinct constructs and require separate psychometric evaluation.

Participants will be recruited from outpatient healthcare facilities and the community in the Andijan region of Uzbekistan using non-probability sampling. Two clinical comparison groups will be formed: individuals with documented primary hypothyroidism, including those receiving levothyroxine, and individuals with normal thyroid function. Thyroid status will not be modified by the study.

At baseline, each participant will complete both questionnaires electronically using standardised Uzbek-language versions. Physical assessments will include handgrip dynamometry, the five-times sit-to-stand test, and a 4-m usual gait-speed test. Anthropometric measurements and relevant clinical information, including thyroid function and treatment history, will also be collected.

An embedded test-retest substudy will involve repeated administration of both questionnaires after 7-14 days. Changes in health status, treatment, mobility, and habitual physical activity will be recorded to identify clinically and behaviourally stable participants.

The primary objective is to assess the test-retest reliability of the SARC-F total score and IPAQ-SF total physical activity estimate. Secondary analyses will examine measurement error, agreement of screening and activity classifications, response distributions, and hypothesis-based construct validity using objective functional measurements. Associations between SARC-F and IPAQ-SF will also be explored without combining their scores into a composite measure.

Exploratory analyses will investigate differences in measurement properties according to thyroid status, sex, and age. Statistical analyses will follow COSMIN methodological principles and report relevant reliability estimates with 95% confidence intervals.

The study will not assess the effects of any treatment. Functional tests will support construct-validity analyses but will not serve as definitive reference standards for diagnosing sarcopenia or objectively measuring habitual physical activity.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

480

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Abdukhalim Abdurakhimov
  • Telefonnummer: +998941010091
  • E-Mail: abduhalim@adti.uz

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study population will comprise Uzbek-speaking adults aged 18 years or older recruited from outpatient healthcare facilities and the community in the Andijan region of Uzbekistan. Participants will include 240 individuals with documented primary hypothyroidism and 240 euthyroid comparison participants. Both sexes will be included. All participants will complete SARC-F and IPAQ-SF, and at least 200 participants will undergo repeat questionnaire administration after 7-14 days.

Beschreibung

Inclusion Criteria:

  • Adults aged 18 years or older, without an upper age limit.
  • Men and women who can understand and complete the Uzbek-language questionnaires.
  • Ability and willingness to provide written informed consent.
  • Documented primary hypothyroidism, including patients receiving levothyroxine replacement therapy, or euthyroid status without known thyroid disease and with thyroid function within the reference range.
  • Willingness to complete both SARC-F and IPAQ-SF questionnaires and participate in the planned assessments.

Exclusion Criteria:

  • Severe cognitive impairment or other conditions preventing reliable questionnaire completion.
  • Acute severe illness at the time of assessment.
  • Severe medical conditions making the planned functional tests unsafe.
  • Previous participation in the preliminary SARC-F or IPAQ-SF adaptation and pilot samples used to develop the Uzbek-language versions.
  • Inability or unwillingness to provide informed consent.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Primary Hypothyroidism

Adults aged 18 years or older with documented primary hypothyroidism, including those receiving levothyroxine replacement therapy. The planned group size is 240 participants. All participants will complete the Uzbek-language SARC-F and IPAQ-SF questionnaires and undergo standardised functional assessments. Approximately 100 participants will repeat both questionnaires after 7-14 days.
Euthyroid Comparison Group

Adults aged 18 years or older without known thyroid disease and with thyroid function within the reference range. The planned group size is 240 participants. All participants will complete the Uzbek-language SARC-F and IPAQ-SF questionnaires and undergo standardised functional assessments. Approximately 100 participants will repeat both questionnaires after 7-14 days.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Test-Retest Reliability of the Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Total Score
Zeitfenster: Baseline and 7-14 days after baseline

Test-retest reliability of the Uzbek-language Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) questionnaire total score (range 0-10, with higher scores indicating greater functional difficulties) will be assessed using a two-way random-effects, absolute-agreement, single-measure intraclass correlation coefficient (ICC) with a 95% confidence interval (CI). Analyses will include clinically stable participants who complete both assessments.
Baseline and 7-14 days after baseline
Test-Retest Reliability of Total Physical Activity Measured by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Zeitfenster: Baseline and 7-14 days after baseline

Test-retest reliability of total physical activity assessed using the Uzbek-language International Physical Activity Questionnaire-Short Form (IPAQ-SF), expressed in metabolic equivalent of task minutes per week (MET-minutes/week) and transformed as log(1 + total MET-minutes/week), will be assessed using a two-way random-effects, absolute-agreement, single-measure intraclass correlation coefficient (ICC) with a 95% confidence interval (CI). Analyses will include clinically and behaviourally stable participants who complete both assessments.
Baseline and 7-14 days after baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
SARC-F Screening Classification Agreement
Zeitfenster: Baseline and 7-14 days after baseline

Agreement between positive (SARC-F score ≥4) and negative (score <4) screening classifications at the two administrations, assessed using Cohen's kappa and percentage agreement.
Baseline and 7-14 days after baseline
IPAQ-SF Physical Activity Category Agreement
Zeitfenster: Baseline and 7-14 days after baseline

Agreement between low, moderate and high physical activity categories at the two administrations, assessed using weighted kappa and percentage agreement.
Baseline and 7-14 days after baseline
Measurement Error of the SARC-F Total Score
Zeitfenster: Baseline and 7-14 days after baseline

Measurement error of the Uzbek-language Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) questionnaire total score (range 0-10; higher scores indicate greater functional difficulties and worse outcomes) will be assessed using the standard error of measurement (SEM), smallest detectable change at the 95% confidence level (SDC95), and Bland-Altman limits of agreement, based on repeated assessments in clinically stable participants.
Baseline and 7-14 days after baseline
Measurement Error of IPAQ-SF Total Physical Activity
Zeitfenster: Baseline and 7-14 days after baseline

SEM, SDC95 and Bland-Altman agreement analysis, where appropriate, for repeated log(1 + total MET-minutes/week) values. Estimates on the transformed scale will be identified accordingly.
Baseline and 7-14 days after baseline
Construct Validity of SARC-F: Handgrip Strength
Zeitfenster: Baseline

Spearman correlation between baseline SARC-F total score (0-10) and handgrip strength measured by dynamometry (kg). A negative association is hypothesised.
Baseline
Construct Validity of SARC-F: Five-Times Sit-to-Stand
Zeitfenster: Baseline

Spearman correlation between baseline SARC-F total score (0-10) and five-times sit-to-stand completion time (seconds). A positive association is hypothesised.
Baseline
Construct Validity of SARC-F: Gait Speed
Zeitfenster: Baseline

Spearman correlation between baseline SARC-F total score (0-10) and usual gait speed over 4 metres (m/s). A negative association is hypothesised.
Baseline
Construct Validity of IPAQ-SF: Gait Speed
Zeitfenster: Baseline

Association between IPAQ-SF total physical activity (MET-minutes/week) and usual 4-m gait speed (m/s), assessed using Spearman correlation. A positive association is hypothesised.
Baseline
Construct Validity of IPAQ-SF: Mobility Limitations
Zeitfenster: Baseline

Association between IPAQ-SF total physical activity (MET-minutes/week) and recorded mobility limitations. Participants with mobility limitations are hypothesised to report lower physical activity.
Baseline

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association Between SARC-F and IPAQ-SF
Zeitfenster: Baseline

Exploratory Spearman correlation between the SARC-F total score and IPAQ-SF total physical activity (MET-minutes/week). A negative association is hypothesised.
Baseline
SARC-F Response Distribution and Internal Consistency
Zeitfenster: Baseline

Distribution of total and item scores, floor and ceiling effects, corrected item-total correlations and internal consistency of the five-item SARC-F questionnaire.
Baseline
Floor Effect of the SARC-F Total Score
Zeitfenster: Baseline

Percentage of participants obtaining the minimum possible total score of 0 on the Uzbek-language Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) questionnaire (range 0-10; higher scores indicate greater functional difficulties). The floor effect will be reported as a percentage.
Baseline
Ceiling Effect of the SARC-F Total Score
Zeitfenster: Baseline

Percentage of participants obtaining the maximum possible total score of 10 on the Uzbek-language Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) questionnaire (range 0-10; higher scores indicate greater functional difficulties). The ceiling effect will be reported as a percentage.
Baseline
Distribution of the SARC-F Total Score
Zeitfenster: Baseline

Baseline total score of the Uzbek-language Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) questionnaire, ranging from 0 to 10 points. Higher scores indicate greater functional difficulties. The distribution will be described using the median and interquartile range.
Baseline
Total Physical Activity Measured by IPAQ-SF
Zeitfenster: Baseline

Total physical activity will be assessed using the Uzbek-language International Physical Activity Questionnaire-Short Form (IPAQ-SF). Weekly physical activity will be calculated from walking, moderate-intensity and vigorous-intensity activities according to the IPAQ-SF scoring protocol and expressed in metabolic equivalent of task minutes per week (MET-minutes/week). Higher values indicate greater reported physical activity. The measure has no fixed maximum score.
Baseline
IPAQ-SF Physical Activity Categories
Zeitfenster: Baseline

Physical activity will be classified as low, moderate or high using the established scoring criteria of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The number and percentage of participants in each category will be reported. Categories reflect increasing levels of reported physical activity.
Baseline
Sitting Time Measured by IPAQ-SF
Zeitfenster: Baseline

Self-reported sitting time during a usual weekday over the preceding seven days will be assessed using the sitting item of the Uzbek-language International Physical Activity Questionnaire-Short Form (IPAQ-SF). Sitting time will be expressed in minutes per day. Higher values indicate longer sedentary time. Valid values range from 0 to 1,440 minutes per day.
Baseline
Invalid or Implausible IPAQ-SF Responses
Zeitfenster: Baseline

The percentage of participants with invalid or implausible baseline responses to the Uzbek-language International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be determined using prespecified data-cleaning and scoring rules. Each participant will be classified as having either valid or invalid/implausible responses. The outcome will be reported as the percentage of participants classified as invalid/implausible.
Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Andijan State Medical Institute

Ermittler

  • Studienleiter: Abdukhalim Abdurakhimov, PhD, Andijan State Medical Institute, Andijan 170127

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

25. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. November 2026

Zuerst gepostet (Tatsächlich)

6. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UZ-SARCF-IPAQ-2026

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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