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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

2815

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Maria Torres-Lacomba, PT, Ph.D.
  • Numero di telefono: +34 918 85 48 28
  • Email: maria.torres@uah.es

Luoghi di studio

  • Spagna
    • Madrid
      • Alcalá de Henares, Madrid, Spagna, 28805
        • University of Alcala
        • Contatto:
        • Contatto:
          • Maria Torres-Lacomba, PT, Ph.D.
          • Numero di telefono: +34 918 85 48 28
          • Email: maria.torres@uah.es

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Isometric quadriceps muscle strength
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Five-repetition sit-to-stand test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Alcala

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

31 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CEIP/2025/6/174

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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).

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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