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Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study (RESTart)

2026. június 4. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

2815

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

  • Név: Maria Torres-Lacomba, PT, Ph.D.
  • Telefonszám: +34 918 85 48 28
  • E-mail: maria.torres@uah.es

Tanulmányi helyek

  • Spanyolország
    • Madrid
      • Alcalá de Henares, Madrid, Spanyolország, 28805
        • University of Alcala
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Igen

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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.
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Isometric quadriceps muscle strength
Időkeret: Day 1
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).
Day 1
Handgrip
Időkeret: Day 1
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).
Day 1

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Five-repetition sit-to-stand test
Időkeret: Day 1
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.
Day 1
One-minute sit-to-stand test
Időkeret: Day 1
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.
Day 1
Timed Up and Go test
Időkeret: Day 1
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.
Day 1
Modified Medical Research Council dyspnoea scale
Időkeret: Day 1
Dyspnoea severity assessed using the modified Medical Research Council dyspnoea scale. Scores range from 0 to 4, with higher scores indicating greater breathlessness.
Day 1
Modified Borg dyspnoea scale
Időkeret: Day 1
Perceived breathlessness assessed using the modified Borg dyspnoea scale. Scores range from 0 to 10, with higher scores indicating greater breathlessness.
Day 1
Dyspnoea-12
Időkeret: Day 1
Dyspnoea assessed using the Dyspnoea-12 questionnaire. The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness.
Day 1
Functional Assessment of Chronic Illness Therapy-Fatigue
Időkeret: Day 1
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Scores range from 0 to 52, with higher scores indicating less fatigue.
Day 1
EuroQol 5-Dimension 5-Level
Időkeret: Day 1
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.
Day 1
St George's Respiratory Questionnaire
Időkeret: Day 1
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.
Day 1
International Physical Activity Questionnaire-short form
Időkeret: Day 1
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).
Day 1
Mini Nutritional Assessment-short form
Időkeret: Day 1
Nutritional status assessed using the Mini Nutritional Assessment-short form. Scores range from 0 to 14, with higher scores indicating better nutritional status.
Day 1

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Age
Időkeret: Day 1
Participant age recorded in completed years.
Day 1
Weight
Időkeret: Day 1
Participant weight recorded in kilograms.
Day 1
Height
Időkeret: Day 1
Participant height recorded in metres.
Day 1
Body mass index
Időkeret: Day 1
Body mass index calculated as weight divided by height squared.
Day 1
Sex
Időkeret: Day 1
Participant biological sex recorded as female or male.
Day 1
Forced expiratory volume in one second percentage predicted (FEV1%pred)
Időkeret: Day 1
Lung function measured by spirometry when available from medical records.
Day 1
Forced vital capacity percentage predicted (FVC%pred)
Időkeret: Day 1
Lung function measured by spirometry when available from medical records.
Day 1
Systemic inflammation markers
Időkeret: Day 1
CRP, IL-6, eosinophils, fibrinogen, neutrophil elastase, ESR, KL-6, SP-D, FeNO, IgE, calprotectin, if available, from medical records.
Day 1
Charlson Comorbidity Index
Időkeret: Day 1
Comorbidity burden assessed using the Charlson Comorbidity Index. Higher scores indicate greater comorbidity burden.
Day 1
Anatomical Therapeutic Chemical (ATC) Classification System
Időkeret: Day 1
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
Day 1
Smoking Exposure (pack-year index)
Időkeret: Day 1
Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
Day 1
Alcohol Use Disorders Identification Test-Consumption
Időkeret: Day 1
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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of Alcala

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. június 1.

Elsődleges befejezés (Becsült)

2029. június 1.

A tanulmány befejezése (Becsült)

2030. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. május 31.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 31.

Első közzététel (Tényleges)

2026. június 5.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. június 8.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. június 4.

Utolsó ellenőrzés

2026. június 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CEIP/2025/6/174

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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 megosztási időkeret

Beginning 12 months following publication of the primary study results and ending 5 years after publication.

IPD-megosztási hozzáférési feltételek

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).

Az IPD megosztását támogató információ típusa

  • STUDY_PROTOCOL
  • NEDV
  • ICF
  • ANALYTIC_CODE

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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