HypothyroidismNCT07923136
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
An observational study of Hypothyroidism and Psychometrics, run by Andijan State Medical Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism, Psychometrics
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hypothyroidism, Psychometrics
- Keywords
- SARC-F, IPAQ-SF, Uzbek Language, Questionnaire Validation, Test-Retest, Physical Activity, Muscle Function, Sarcopenia, Screening
- Medical subject headings
- Hypothyroidism, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 7-14 days after baseline
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andijan State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdukhalim Abdurakhimov, PhD, Study director, Andijan State Medical Institute, Andijan 170127
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923136
- Sponsor's protocol ID
- UZ-SARCF-IPAQ-2026
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Uzbek-Language SARC-F and IPAQ-SF Among Adults With and Without Primary Hypothyroidism
- ClinicalTrials.gov ID
- NCT07923136
- Acronym / sponsor ID
- UZ-SARCF-IPAQ-2026
- Conditions
- Hypothyroidism, Psychometrics
- Keywords
- SARC-F, IPAQ-SF, Uzbek Language, Questionnaire Validation, Test-Retest, Physical Activity, Muscle Function, Sarcopenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Andijan State Medical InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test-Retest Reliability of the Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Total Score
Time frame: 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.
Test-Retest Reliability of Total Physical Activity Measured by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: 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.
9 secondary outcomes
SARC-F Screening Classification Agreement
Time frame: Baseline and 7-14 days after baseline
IPAQ-SF Physical Activity Category Agreement
Time frame: Baseline and 7-14 days after baseline
Measurement Error of the SARC-F Total Score
Time frame: Baseline and 7-14 days after baseline
Measurement Error of IPAQ-SF Total Physical Activity
Time frame: Baseline and 7-14 days after baseline
Construct Validity of SARC-F: Handgrip Strength
Time frame: Baseline
Construct Validity of SARC-F: Five-Times Sit-to-Stand
Time frame: Baseline
Construct Validity of SARC-F: Gait Speed
Time frame: Baseline
Construct Validity of IPAQ-SF: Gait Speed
Time frame: Baseline
Construct Validity of IPAQ-SF: Mobility Limitations
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdukhalim Abdurakhimov, PhD study director
Andijan State Medical Institute, Andijan 170127
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and Psychometrics, run by Andijan State Medical Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdukhalim Abdurakhimov (+998941010091, abduhalim@adti.uz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest Reliability of the Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Total Score (time frame: Baseline and 7-14 days after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.