NCT07628530Not yet recruiting
Reference Equations and Normative Data for Isometric Quadriceps and Handgrip Muscles STrength in Southern European Populations - RESTart: a Multicentre Study
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2815 (estimated)
- First submitted
- 31 May 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- University of Alcala
- Diseases
- Cystic fibrosis, Asthma
- NCT number
- NCT07628530
What you commit to
- Study type: Observational
- Planned participants: 2815
- From Jun 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent surgery (e.g., within the past six months) in upper or lower limbs.
- 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).
Other illness
- Acute or chronic musculoskeletal conditions affecting strength: recent fractures, severe osteoarthrosis, ligament injury, acute tendinitis in hands/knee areas, among others.
- 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.
- Current smoking.
- Chronic respiratory disease cohort
- Coexisting conditions which meet the exclusion criteria defined for healthy participants, apart from chronic respiratory diseases.
Other
- Aid devices for walking or compromised functional mobility.
- Moderate-to-severe pain during the assessment (VAS ≥4).
- Pregnancy and postpartum (i.e., potential physiological changes which may alter muscle strength).
- Current requirement for hospitalisation or acute medical management.
- Severe functional limitation preventing completion of assessments.
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Healthy adults cohort
Age in the registry: 18 years to 89 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alcalá Coordinator of this site? Confirm its status | Alcalá de Henares | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.