Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study (RESTart)
2026年6月4日 更新者：Nicola S. Diciolla、University of Alcala
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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
2815
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nicola S. Diciolla, PT, Ph.D.
- 電話番号：+34 918 85 48 28
- メール：nicola.diciolla@uah.es
研究連絡先のバックアップ
- 名前：Maria Torres-Lacomba, PT, Ph.D.
- 電話番号：+34 918 85 48 28
- メール：maria.torres@uah.es
研究場所
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Madrid
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Alcalá de Henares、Madrid、スペイン、28805
- University of Alcala
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コンタクト：
- Nicola S. Diciolla, PT, Ph.D.
- 電話番号：+34 918 85 48 28
- メール：nicola.diciolla@uah.es
-
コンタクト：
- Maria Torres-Lacomba, PT, Ph.D.
- 電話番号：+34 918 85 48 28
- メール：maria.torres@uah.es
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Community-dwelling healthy adults and adults with chronic respiratory diseases recruited from participating centres in Spain, Portugal and Italy.
Healthy participants will be recruited from the general population to develop reference equations and normative values for isometric quadriceps and handgrip strength.
Participants with chronic respiratory diseases will be recruited from clinical settings to externally validate the developed reference equations and assess their clinical applicability.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Isometric quadriceps muscle strength
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Five-repetition sit-to-stand test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age
時間枠：Day 1
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Participant age recorded in completed years.
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Day 1
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Weight
時間枠：Day 1
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Participant weight recorded in kilograms.
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Day 1
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Height
時間枠：Day 1
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Participant height recorded in metres.
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Day 1
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Body mass index
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Day 1
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Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
|
Day 1
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Alcohol Use Disorders Identification Test-Consumption
時間枠：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.
|
Day 1
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2029年6月1日
研究の完了 (推定)
2030年6月1日
試験登録日
最初に提出
2026年5月31日
QC基準を満たした最初の提出物
2026年5月31日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CEIP/2025/6/174
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the results reported in publications arising from this study, including demographic characteristics, anthropometric measurements, peripheral muscle strength assessments, functional capacity outcomes, patient-reported outcomes/questionnaire scores, and other variables collected according to the study protocol, upon reasonable request to the principal investigator.
IPD 共有時間枠
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal for secondary analyses consistent with the aims of the study (e.g., individual participant data meta-analyses, validation studies, methodological research, and other scientifically justified secondary analyses).
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。