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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity of Alcala

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

2,815 Participants
are grouped into 2 trial groups
Group A: Healthy adults cohort
Group B: Chronic respiratory disease cohort

Trial outcomes

Primary outcomes

1

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).

Time frame
Day 1
2

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).

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1
2

One-minute sit-to-stand test

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.

Time frame
Day 1
3

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.

Time frame
Day 1
4

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.

Time frame
Day 1

Other outcomes

1

Age

Participant age recorded in completed years.

Time frame
Day 1
2

Weight

Participant weight recorded in kilograms.

Time frame
Day 1
3

Height

Participant height recorded in metres.

Time frame
Day 1
4

Body mass index

Body mass index calculated as weight divided by height squared.

Time frame
Day 1

Sponsors and contacts

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