Chronic Respiratory Diseases, Healthy, Muscle Strength
Conditions
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
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Alcala
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isometric quadriceps muscle strength | 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). |
| Handgrip | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Five-repetition sit-to-stand test | 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. |
| One-minute sit-to-stand test | 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. |
| Timed Up and Go test | 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. |
| Modified Medical Research Council dyspnoea scale | 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. |
| Modified Borg dyspnoea scale | Day 1 | Perceived breathlessness assessed using the modified Borg dyspnoea scale. Scores range from 0 to 10, with higher scores indicating greater breathlessness. |
| Dyspnoea-12 | Day 1 | Dyspnoea assessed using the Dyspnoea-12 questionnaire. The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness. |
| Functional Assessment of Chronic Illness Therapy-Fatigue | 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. |
| EuroQol 5-Dimension 5-Level | 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. |
| St George's Respiratory Questionnaire | 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. |
| International Physical Activity Questionnaire-short form | 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). |
| Mini Nutritional Assessment-short form | 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. |
Countries
Spain
Contacts
CONTACTNicola S. Diciolla, PT, Ph.D.
CONTACTMaría Torres-Lacomba, PT, Ph.D.
Outcome results
None listed