- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07628530
Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study (RESTart)
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.
Descripción general del estudio
Estado
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicola S. Diciolla, PT, Ph.D.
- Número de teléfono: +34 918 85 48 28
- Correo electrónico: nicola.diciolla@uah.es
Copia de seguridad de contactos de estudio
- Nombre: Maria Torres-Lacomba, PT, Ph.D.
- Número de teléfono: +34 918 85 48 28
- Correo electrónico: maria.torres@uah.es
Ubicaciones de estudio
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Madrid
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Alcalá de Henares, Madrid, España, 28805
- University of Alcala
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Contacto:
- Nicola S. Diciolla, PT, Ph.D.
- Número de teléfono: +34 918 85 48 28
- Correo electrónico: nicola.diciolla@uah.es
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Contacto:
- Maria Torres-Lacomba, PT, Ph.D.
- Número de teléfono: +34 918 85 48 28
- Correo electrónico: maria.torres@uah.es
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Isometric quadriceps muscle strength
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Five-repetition sit-to-stand test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Age
Periodo de tiempo: Day 1
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Participant age recorded in completed years.
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Day 1
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Weight
Periodo de tiempo: Day 1
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Participant weight recorded in kilograms.
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Day 1
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Height
Periodo de tiempo: Day 1
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Participant height recorded in metres.
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Day 1
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Body mass index
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Day 1
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Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
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Day 1
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Alcohol Use Disorders Identification Test-Consumption
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Asma
- EPOC
- Rehabilitación pulmonar
- Fibrosis quística
- Bronquiectasias
- Enfermedad pulmonar intersticial
- Fuerza muscular
- Adultos sanos
- Ecuaciones de referencia
- Empuñadura
- Valores de referencia
- Fuerza de cuádriceps
- Enfermedades respiratorias cronicas
- Datos normativos
- Dynamometrry
- Peripheral muscle dysfunction
- Southern Europe
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades pancreáticas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad Pulmonar Obstructiva Crónica
- Asma
- Enfermedades Pulmonares Intersticiales
- Fibrosis quística
- Bronquiectasias
Otros números de identificación del estudio
- CEIP/2025/6/174
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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