Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
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.
研究概览
地位
地位
详细说明
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.
研究类型
研究类型
注册 (估计的)
注册
联系人和位置
学习联系方式
学习联系方式
- 姓名:Abdukhalim Abdurakhimov
- 电话号码:+998941010091
- 邮箱:abduhalim@adti.uz
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
团体/队列数
队列和干预
团体/队列团体/队列 |
|---|
|
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. |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Test-Retest Reliability of the Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Total Score
大体时间: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)
大体时间: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
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SARC-F Screening Classification Agreement
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Association Between SARC-F and IPAQ-SF
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
合作者和调查者
调查人员
调查人员
- 研究主任:Abdukhalim Abdurakhimov, PhD、Andijan State Medical Institute, Andijan 170127
研究记录日期
研究主要日期
学习开始 (估计的)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他研究编号
其他研究编号
- UZ-SARCF-IPAQ-2026
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.