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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:
Participants will attend one study visit. During this visit, researchers will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Isometric quadriceps muscle strength | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Five-repetition sit-to-stand test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Participant age recorded in completed years. | Day 1 |
| Weight | Participant weight recorded in kilograms. | Day 1 |
Healthy adults cohort
Inclusion Criteria:
Exclusion Criteria:
Chronic respiratory disease cohort
Inclusion criteria:
Exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola S. Diciolla, PT, Ph.D. | Contact | +34 918 85 48 28 | nicola.diciolla@uah.es | |
| MarÃa Torres-Lacomba, PT, Ph.D. | Contact | +34 918 85 48 28 | maria.torres@uah.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alcalá | Alcalá de Henares | Madrid | 28805 | Spain |
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.
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
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).
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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. |
| Day 1 |
| Timed Up and Go test | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Height | Participant height recorded in metres. | Day 1 |
| Body mass index | Body mass index calculated as weight divided by height squared. | Day 1 |
| Sex | Participant biological sex recorded as female or male. | Day 1 |
| Forced expiratory volume in one second percentage predicted (FEV1%pred) | Lung function measured by spirometry when available from medical records. | Day 1 |
| Forced vital capacity percentage predicted (FVC%pred) | Lung function measured by spirometry when available from medical records. | Day 1 |
| Systemic inflammation markers | 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 | Comorbidity burden assessed using the Charlson Comorbidity Index. Higher scores indicate greater comorbidity burden. | Day 1 |
| Anatomical Therapeutic Chemical (ATC) Classification System | Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System. | Day 1 |
| Smoking Exposure (pack-year index) | Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history. | Day 1 |
| Alcohol Use Disorders Identification Test-Consumption | 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D001987 | Bronchiectasis |
| D017563 | Lung Diseases, Interstitial |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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