Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study (RESTart)
This observational study aims to learn about peripheral muscle strength in healthy adults and people with chronic respiratory diseases. The study aims to develop reference data for quadriceps muscle strength and handgrip in adults living in Southern Europe and to assess whether these reference data can be used in people with chronic respiratory diseases.
The main questions it aims to answer are:
- What are the normal values for quadriceps and handgrip muscle strength in healthy adults aged 18-89 years living in Spain, Portugal and Italy?
- Can the reference values developed in healthy adults be applied to people with chronic respiratory diseases?
Participants will attend one study visit. During this visit, researchers will:
- Measure quadriceps muscle strength and handgrip.
- Collect information about age, sex, height, weight and other health characteristics.
- Perform simple functional tests related to mobility and physical performance.
- Ask participants to complete questionnaires about symptoms, physical activity and health-related quality of life.
研究概览
详细说明
The RESTart study (Reference equations and normative data for isometric quadriceps and handgrip STrength in Southern European populations) is a multicentre observational cross-sectional study conducted in Spain, Portugal and Italy.
Peripheral muscle dysfunction, particularly reduced quadriceps muscle strength and handgrip, is common in people with chronic respiratory diseases and is associated with impaired physical function, hospitalisation and mortality. Accurate interpretation of muscle strength measurements requires population-specific reference equations and normative values. However, currently available reference data may not adequately represent Southern European populations.
The primary objective of the study is to develop reference equations and normative values for isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years. A secondary objective is to validate/assess clinical application of these reference data in people with chronic respiratory diseases, including chronic obstructive pulmonary disease, interstitial lung disease, asthma, bronchiectasis and cystic fibrosis.
Healthy participants will be recruited from community settings using proportional stratification according to age, sex and country. Participants with chronic respiratory diseases will be recruited from collaborating clinical centres.
Primary outcomes are isometric quadriceps muscle strength and handgrip assessed using standardised dynamometry protocols. Secondary outcomes include functional capacity, mobility and balance, symptoms, physical activity, health-related quality of life, and anthropometric variables; lung function and laboratory parameters only when available from medical records.
The study is expected to provide robust reference equations and normative values for Southern European populations, supporting improved identification and monitoring of peripheral muscle dysfunction in both clinical practice and research.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Nicola S. Diciolla, PT, Ph.D.
- 电话号码:+34 918 85 48 28
- 邮箱:nicola.diciolla@uah.es
研究联系人备份
- 姓名:Maria Torres-Lacomba, PT, Ph.D.
- 电话号码:+34 918 85 48 28
- 邮箱:maria.torres@uah.es
学习地点
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Madrid
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Alcalá de Henares、Madrid、西班牙、28805
- University of Alcala
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接触:
- Nicola S. Diciolla, PT, Ph.D.
- 电话号码:+34 918 85 48 28
- 邮箱:nicola.diciolla@uah.es
-
接触:
- Maria Torres-Lacomba, PT, Ph.D.
- 电话号码:+34 918 85 48 28
- 邮箱:maria.torres@uah.es
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Healthy adults cohort
Inclusion Criteria:
- Age between 18-89 years.
- Spanish, Portuguese or Italian, or permanently resident in one of those countries for at least five years.
- Be community-dwelling (i.e., not hospitalised or institutionalised).
- Be functionally independent and capable of performing study assessments without assistance or limiting pain.
- Be able to follow verbal instructions in the local language (Spanish, Portuguese or Italian, as appropriate).
- Provide written informed consent.
Exclusion Criteria:
- Acute or chronic musculoskeletal conditions affecting strength: recent fractures, severe osteoarthrosis, ligament injury, acute tendinitis in hands/knee areas, among others.
- Recent surgery (e.g., within the past six months) in upper or lower limbs.
- Neuromuscular disorders: Parkinson, multiple sclerosis, stroke, peripheral neuropathies, among others.
- Non-communicable diseases affecting strength or functional status: active cancer, any unstable heart diseases; any CRD; active rheumatological diseases, obesity (BMI≥30kg/m2), uncontrolled metabolic diseases, among others (not included: controlled dyslipidaemia or arterial hypertension).
- Cognitive impairments (e.g., dementia) or psychiatric disorders impairing following instructions.
- Aid devices for walking or compromised functional mobility.
- Moderate-to-severe pain during the assessment (VAS ≥4).
- Systemic corticosteroids use for over one week in the previous six months (i.e., risk of muscle atrophy in type II fibres; or steroid myopathy).
- Muscle relaxants use during the previous week (i.e., risk of not full muscle activation).
- Pregnancy and postpartum (i.e., potential physiological changes which may alter muscle strength).
- Current smoking.
Chronic respiratory disease cohort
Inclusion criteria:
- Aged 18-89 years.
- Clinical diagnosis of a chronic respiratory disease (e.g., COPD, interstitial lung disease, asthma, bronchiectasis, cystic fibrosis), confirmed by spirometry or clinical records.
- Clinically stable (no exacerbation within the past four weeks).
- Capacity to provide informed consent and complete study procedures.
Exclusion criteria:
- Coexisting conditions which meet the exclusion criteria defined for healthy participants, apart from chronic respiratory diseases.
- Current requirement for hospitalisation or acute medical management.
- Severe functional limitation preventing completion of assessments.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Healthy adults cohort
Healthy community-dwelling adults aged 18-89 years recruited in Spain, Portugal and Italy for the development of reference equations and normative data for isometric quadriceps strength and handgrip.
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Chronic respiratory disease cohort
Adults with stable chronic respiratory diseases recruited for external validation/clinical application of the developed reference equations and normative values.
Eligible conditions include chronic obstructive pulmonary disease, interstitial lung disease, asthma, bronchiectasis and cystic fibrosis.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Isometric quadriceps muscle strength
大体时间:Day 1
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Quadricpes maximum voluntary contraction measured using a handheld dynamometer according to the standardised RESTart protocol.
Strength will be recorded as the highest value obtained during the assessment and expressed in kilograms-force (kgf).
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Day 1
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Handgrip
大体时间:Day 1
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Handgrip mMaximum voluntary contraction measured using a hydraulic handgrip dynamometer according to standardised assessment procedures.
Strength will be recorded as the highest value obtained during the assessment and expressed in kilograms-force (kgf).
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Five-repetition sit-to-stand test
大体时间:Day 1
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Functional capacity assessed by the time required to complete five sit-to-stand repetitions according to standardised procedures.
Results will be expressed in seconds.
Lower values indicate better lower-limb functional capacity.
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Day 1
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One-minute sit-to-stand test
大体时间:Day 1
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Functional capacity assessed as the number of sit-to-stand repetitions completed in one minute according to standardised procedures.
Higher values indicate better functional exercise capacity.
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Day 1
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Timed Up and Go test
大体时间:Day 1
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Mobility and dynamic balance assessed using the Timed Up and Go test.
Results will be expressed in seconds.
Lower values indicate better mobility and dynamic balance.
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Day 1
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Modified Medical Research Council dyspnoea scale
大体时间:Day 1
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Dyspnoea severity assessed using the modified Medical Research Council dyspnoea scale.
Scores range from 0 to 4, with higher scores indicating greater breathlessness.
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Day 1
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Modified Borg dyspnoea scale
大体时间:Day 1
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Perceived breathlessness assessed using the modified Borg dyspnoea scale.
Scores range from 0 to 10, with higher scores indicating greater breathlessness.
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Day 1
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Dyspnoea-12
大体时间:Day 1
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Dyspnoea assessed using the Dyspnoea-12 questionnaire.
The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness.
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Day 1
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Functional Assessment of Chronic Illness Therapy-Fatigue
大体时间:Day 1
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Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Scores range from 0 to 52, with higher scores indicating less fatigue.
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Day 1
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EuroQol 5-Dimension 5-Level
大体时间:Day 1
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Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D) questionnaire.
The index score will be calculated according to the appropriate national value set.
Higher scores indicate better health status.
Self-rated health assessed using the EQ-5D Visual Analogue Scale.
Scores range from 0 to 100, with higher scores indicating better perceived health.
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Day 1
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St George's Respiratory Questionnaire
大体时间:Day 1
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Respiratory-specific health-related quality of life assessed using the St George's Respiratory Questionnaire.
Scores range from 0 to 100, with higher scores indicating worse respiratory health-related quality of life.
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Day 1
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International Physical Activity Questionnaire-short form
大体时间:Day 1
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Physical activity assessed using the International Physical Activity Questionnaire-short form.
Results will be expressed as minutes per week spent in vigorous/moderate/total physical activity, time per week spent walking and hours per day spent in sedentary behaviour (sitting).
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Day 1
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Mini Nutritional Assessment-short form
大体时间:Day 1
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Nutritional status assessed using the Mini Nutritional Assessment-short form.
Scores range from 0 to 14, with higher scores indicating better nutritional status.
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Day 1
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Age
大体时间:Day 1
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Participant age recorded in completed years.
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Day 1
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Weight
大体时间:Day 1
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Participant weight recorded in kilograms.
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Day 1
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Height
大体时间:Day 1
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Participant height recorded in metres.
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Day 1
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Body mass index
大体时间:Day 1
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Body mass index calculated as weight divided by height squared.
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Day 1
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Sex
大体时间:Day 1
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Participant biological sex recorded as female or male.
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Day 1
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Forced expiratory volume in one second percentage predicted (FEV1%pred)
大体时间:Day 1
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Lung function measured by spirometry when available from medical records.
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Day 1
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Forced vital capacity percentage predicted (FVC%pred)
大体时间:Day 1
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Lung function measured by spirometry when available from medical records.
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Day 1
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Systemic inflammation markers
大体时间:Day 1
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CRP, IL-6, eosinophils, fibrinogen, neutrophil elastase, ESR, KL-6, SP-D, FeNO, IgE, calprotectin, if available, from medical records.
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Day 1
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Charlson Comorbidity Index
大体时间:Day 1
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Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
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Day 1
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Anatomical Therapeutic Chemical (ATC) Classification System
大体时间:Day 1
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Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
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Day 1
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Smoking Exposure (pack-year index)
大体时间:Day 1
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Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
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Day 1
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Alcohol Use Disorders Identification Test-Consumption
大体时间:Day 1
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Alcohol consumption assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
Higher scores indicate greater alcohol consumption and increased risk of hazardous drinking.
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Day 1
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CEIP/2025/6/174
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
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