Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study (RESTart)
2026년 6월 4일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
2815
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Nicola S. Diciolla, PT, Ph.D.
- 전화번호: +34 918 85 48 28
- 이메일: nicola.diciolla@uah.es
연구 연락처 백업
- 이름: Maria Torres-Lacomba, PT, Ph.D.
- 전화번호: +34 918 85 48 28
- 이메일: maria.torres@uah.es
연구 장소
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Madrid
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Alcalá de Henares, Madrid, 스페인, 28805
- University of Alcala
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연락하다:
- Nicola S. Diciolla, PT, Ph.D.
- 전화번호: +34 918 85 48 28
- 이메일: nicola.diciolla@uah.es
-
연락하다:
- Maria Torres-Lacomba, PT, Ph.D.
- 전화번호: +34 918 85 48 28
- 이메일: maria.torres@uah.es
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
2
코호트 및 개입
그룹/코호트그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Isometric quadriceps muscle strength
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Five-repetition sit-to-stand test
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Age
기간: Day 1
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Participant age recorded in completed years.
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Day 1
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Weight
기간: Day 1
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Participant weight recorded in kilograms.
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Day 1
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Height
기간: Day 1
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Participant height recorded in metres.
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Day 1
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Body mass index
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: Day 1
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Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
|
Day 1
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Smoking Exposure (pack-year index)
기간: Day 1
|
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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
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기본 완료 (추정된)
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2029년 6월 1일
연구 완료 (추정된)
연구 완료
2030년 6월 1일
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추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CEIP/2025/6/174
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .