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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)

4 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

2815

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

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

Studie Locaties

  • Spanje
    • Madrid
      • Alcalá de Henares, Madrid, Spanje, 28805
        • University of Alcala
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Isometric quadriceps muscle strength
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Five-repetition sit-to-stand test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Age
Tijdsspanne: Day 1
Participant age recorded in completed years.
Day 1
Weight
Tijdsspanne: Day 1
Participant weight recorded in kilograms.
Day 1
Height
Tijdsspanne: Day 1
Participant height recorded in metres.
Day 1
Body mass index
Tijdsspanne: Day 1
Body mass index calculated as weight divided by height squared.
Day 1
Sex
Tijdsspanne: Day 1
Participant biological sex recorded as female or male.
Day 1
Forced expiratory volume in one second percentage predicted (FEV1%pred)
Tijdsspanne: Day 1
Lung function measured by spirometry when available from medical records.
Day 1
Forced vital capacity percentage predicted (FVC%pred)
Tijdsspanne: Day 1
Lung function measured by spirometry when available from medical records.
Day 1
Systemic inflammation markers
Tijdsspanne: 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
Tijdsspanne: Day 1
Comorbidity burden assessed using the Charlson Comorbidity Index. Higher scores indicate greater comorbidity burden.
Day 1
Anatomical Therapeutic Chemical (ATC) Classification System
Tijdsspanne: Day 1
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
Day 1
Smoking Exposure (pack-year index)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Alcala

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2029

Studie voltooiing (Geschat)

1 juni 2030

Studieregistratiedata

Eerst ingediend

31 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CEIP/2025/6/174

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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