An observational study in Hypothyroidism and Psychometrics, sponsored by Andijan State Medical Institute. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Andijan State Medical Institute · Observational
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.
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.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 480 is above the median of 148 across 98 observational studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Andijan State Medical Institute is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Test-Retest Reliability of the Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Total Score
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.
Time frame: 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)
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.
Time frame: Baseline and 7-14 days after baseline
SARC-F Screening Classification Agreement
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.
Time frame: Baseline and 7-14 days after baseline
IPAQ-SF Physical Activity Category Agreement
Agreement between low, moderate and high physical activity categories at the two administrations, assessed using weighted kappa and percentage agreement.
Time frame: Baseline and 7-14 days after baseline
Measurement Error of the SARC-F Total Score
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.
Time frame: Baseline and 7-14 days after baseline
Measurement Error of IPAQ-SF Total Physical Activity
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.
Time frame: Baseline and 7-14 days after baseline
Construct Validity of SARC-F: Handgrip Strength
Spearman correlation between baseline SARC-F total score (0-10) and handgrip strength measured by dynamometry (kg). A negative association is hypothesised.
Time frame: Baseline
Construct Validity of SARC-F: Five-Times Sit-to-Stand
Spearman correlation between baseline SARC-F total score (0-10) and five-times sit-to-stand completion time (seconds). A positive association is hypothesised.
Time frame: Baseline
Construct Validity of SARC-F: Gait Speed
Spearman correlation between baseline SARC-F total score (0-10) and usual gait speed over 4 metres (m/s). A negative association is hypothesised.
Time frame: Baseline
Construct Validity of IPAQ-SF: Gait Speed
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.
Time frame: Baseline
Construct Validity of IPAQ-SF: Mobility Limitations
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.
Time frame: Baseline
Association Between SARC-F and IPAQ-SF
Exploratory Spearman correlation between the SARC-F total score and IPAQ-SF total physical activity (MET-minutes/week). A negative association is hypothesised.
Time frame: Baseline
SARC-F Response Distribution and Internal Consistency
Distribution of total and item scores, floor and ceiling effects, corrected item-total correlations and internal consistency of the five-item SARC-F questionnaire.
Time frame: Baseline
Floor Effect of the SARC-F Total Score
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.
Time frame: Baseline
Ceiling Effect of the SARC-F Total Score
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.
Time frame: Baseline
Distribution of the SARC-F Total Score
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.
Time frame: Baseline
Total Physical Activity Measured by IPAQ-SF
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.
Time frame: Baseline
IPAQ-SF Physical Activity Categories
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.
Time frame: Baseline
Sitting Time Measured by IPAQ-SF
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.
Time frame: Baseline
Invalid or Implausible IPAQ-SF Responses
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.
Time frame: Baseline
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Andijan State Medical Institute