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

NCT07628530 | Not Yet Recruiting

• 1 other identifier: CEIP/2025/6/174
• Study Type: observational
• Target: 2,815
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Strength; Healthy; Chronic Respiratory Diseases

Keywords

Quadriceps strength; Handgrip; Muscle strength; Reference equations; Reference values; Normative data; Dynamometrry; Healthy adults; Peripheral muscle dysfunction; Chronic respiratory diseases; COPD; Asthma; Bronchiectasis; Interstitial lung disease; Cystic fibrosis; Pulmonary rehabilitation; Southern Europe

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Five-repetition sit-to-stand test

  Day 1

• One-minute sit-to-stand test

  Day 1

• Timed Up and Go test

  Day 1

• Modified Medical Research Council dyspnoea scale

  Day 1

• Modified Borg dyspnoea scale

  Day 1

Other Outcomes (12)

• Age

  Day 1

• Weight

  Day 1

• Height

  Day 1

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Bronchiectasis; Lung Diseases, Interstitial; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Nicola S. Diciolla, PT, Ph.D.

CONTACT

+34 918 85 48 28; nicola.diciolla@uah.es

María Torres-Lacomba, PT, Ph.D.

CONTACT

+34 918 85 48 28; maria.torres@uah.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, M.Sc., Ph.D.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months following publication of the primary study results and ending 5 years after publication.
• Access Criteria: 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).

Locations

ES (1)