Muscle StrenghESPAI-FNCT06280586
Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly
A study testing Multidisciplinary intervention in people with Muscle Strengh and Frailty, run by Consorci Sanitari del Maresme at 2 sites in Spain.
Trial summary
Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Muscle Strengh, Frailty, Sarcopenia
- What is being tested?
- Multidisciplinary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men or women 70 years of age or older at the time of recruitment
- That they meet pre-frail phenotype criteria according to L. Fried's criteria
- That they give their written informed consent to participate in the study.
Who cannot join
- Severe dementia (GDS>3)
- Other neurodegenerative diseases (Parkinson's disease)
- Neuromuscular diseases
- Serious psychiatric illness that, at the doctor's discretion, prevents good compliance with the study intervention
- Active cancer
- Life expectancy of less than 6 months
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- Institutionalized patient
- Unstable ischemic heart disease, uncontrolled arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, uncontrolled arterial hypertension (>180/100mmHg), or severe heart failure.
- Acute diseases or acute or poorly controlled chronic diseases
- Bone fractures in the last 3 months.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Consorci Sanitari del Maresme
Mataró, Barcelona, 08304
Mateu Serra-Prat
Mataró, Barcelona, 08304
About this study
Official title: Effectiveness of a Multimodal and Multidisciplinary Intervention (ESPAI-Fragility) in the Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Elderly in the Community. Randomized Controlled Clinical Trial.
Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.
The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.
Read more
These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.
In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in.
Read the detailed description
General objective:
To assess the effectiveness and safety of a multimodal and multidisciplinary intervention in the prevention of sarcopenia, frailty and functional decline in pre-frail community elders aged 70 years or older.
Specific objectives:
- Evaluate the effect of the study intervention in the medium term (1 year) in terms of prevention or improvement of:
- Muscle strength, muscle mass and sarcopenia,
- The fragility
- Functional capacity (and/or dependence), balance and the risk of falls
- Nutritional status
- The quality of life
- The consumption of health resources in pre-frail community elders 70 years or older.
- To evaluate the safety of the mid-term study intervention (1 year) in pre-frail community elders aged 70 years or older.
Secondary objectives:
- Assess the degree of adherence to the study intervention.
- Evaluate the factors related to good adherence to the study intervention.
- Describe the main characteristics of pre-frail community elders and analyze the factors associated with sarcopenia and functional impairment in the study population (cross-sectional analysis).
- Describe the survival of the study sample and find out what the main determinants are (longitudinal analysis).
- Conditions
- Muscle Strengh, Frailty, Sarcopenia
- Being tested
- Multidisciplinary intervention
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary interventionOther
- bimonthly personalized follow-up with the appropriate specialists (5 in a year) i
- a program of group activities (6 sessions in a year) with a monitor with the aim of reinforcing adherence to the study intervention and adapting it to the circumstances and the physical, personal and social reality around each participant. The sessions will last approximately one hour and will cover:
- General dietary and hydration recommendations and dietary recommendations for people at risk of malnutrition
- Dietary and physical exercise recommendations in obese elderly
- General physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopenia
- Physical exercise recommendations for the elderly at risk of falls.
- Medication management and social resources for the elderly in Mataró.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual clinical practice |
| Intervention | Experimental | * bimonthly personalized follow-up with the appropriate specialists (5 in a year) i
* a program of group activities (6 sessions in a year) with a monitor with the aim of reinforcing adherence to the study intervention and adapting it to the circumstances and the physical, personal and social reality around each participant. The sessions will last approximately one hour and will cover:
* General dietary and hydration recommendations and dietary recommendations for people at risk of malnutrition
* Dietary and physical exercise recommendations in obese elderly
* General physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopenia
* Physical exercise recommendations for the elderly at risk of falls.
* Medication management and social resources for the elderly in Mataró. Receives: Other: Multidisciplinary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Bioimpedance
Measured: baseline, 6 months and 12 months
Muscle strength and/or Muscle function
Isokinetic
Measured: baseline, 6 months and 12 months
Sarcopenia
EWGSOP2 description
Measured: baseline, 6 months and 12 months
Frailty
L Fried Criteria
Measured: baseline, 6 months and 12 months
Secondary outcomes (6)
Functional Capacity 1
Barthel index
Measured: baseline, 6 months and 12 months
Functional Capacity 2
Lawton index
Measured: baseline, 6 months and 12 months
Functional Capacity 3
Timed up and go test
Measured: baseline, 6 months and 12 months
Functional Capacity 4
SPPB
Measured: baseline, 6 months and 12 months
Functional Capacity 5
Unipodal test
Measured: baseline, 6 months and 12 months
Functional Capacity 6
Walking speed mesured by looking time to walk 4.6 meters
Measured: baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Nov 2021
- Primary completion30 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrenghStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateu Serra Prat, Consorci Sanitari del Maresme
- Investigators
- Mateu Serra-Prat, MD PhD, Principal investigator, Fundació Privada Salut del Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280586
- Sponsor's protocol ID
- 44/21
- Acronym
- ESPAI-F
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal and Multidisciplinary Intervention (ESPAI-Fragility) in the Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Elderly in the Community. Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06280586
- Acronym / sponsor ID
- ESPAI-F / 44/21
- Conditions
- Muscle Strengh, Frailty, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.
The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.
These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.
In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in.
Detailed description
General objective:
To assess the effectiveness and safety of a multimodal and multidisciplinary intervention in the prevention of sarcopenia, frailty and functional decline in pre-frail community elders aged 70 years or older.
Specific objectives:
- Evaluate the effect of the study intervention in the medium term (1 year) in terms of prevention or improvement of:
- Muscle strength, muscle mass and sarcopenia,
- The fragility
- Functional capacity (and/or dependence), balance and the risk of falls
- Nutritional status
- The quality of life
- The consumption of health resources in pre-frail community elders 70 years or older.
- To evaluate the safety of the mid-term study intervention (1 year) in pre-frail community elders aged 70 years or older.
Secondary objectives:
- Assess the degree of adherence to the study intervention.
- Evaluate the factors related to good adherence to the study intervention.
- Describe the main characteristics of pre-frail community elders and analyze the factors associated with sarcopenia and functional impairment in the study population (cross-sectional analysis).
- Describe the survival of the study sample and find out what the main determinants are (longitudinal analysis).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual clinical practice |
| Intervention | Experimental | Other: Multidisciplinary intervention* bimonthly personalized follow-up with the appropriate specialists (5 in a year) i * a program of group activities (6 sessions in a year) with a monitor with the aim of reinforcing adherence to the study intervention and adapting it to the circumstances and the physical, personal and social reality around each participant. The sessions will last approximately one hour and will cover: * General dietary and hydration recommendations and dietary recommendations for people at risk of malnutrition * Dietary and physical exercise recommendations in obese elderly * General physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopenia * Physical exercise recommendations for the elderly at risk of falls. * Medication management and social resources for the elderly in Mataró. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men or women 70 years of age or older at the time of recruitment
- That they meet pre-frail phenotype criteria according to L. Fried's criteria
- That they give their written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Severe dementia (GDS>3)
- Other neurodegenerative diseases (Parkinson's disease)
- Neuromuscular diseases
- Serious psychiatric illness that, at the doctor's discretion, prevents good compliance with the study intervention
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary intervention* bimonthly personalized follow-up with the appropriate specialists (5 in a year) i * a program of group activities (6 sessions in a year) with a monitor with the aim of reinforcing adherence to the study intervention and adapting it to the circumstances and the physical, personal and social reality around each participant. The sessions will last approximately one hour and will cover: * General dietary and hydration recommendations and dietary recommendations for people at risk of malnutrition * Dietary and physical exercise recommendations in obese elderly * General physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopenia * Physical exercise recommendations for the elderly at risk of falls. * Medication management and social resources for the elderly in Mataró. | Other | Intervention |
Primary outcome
Muscle Mass
Time frame: baseline, 6 months and 12 months
Bioimpedance
Muscle strength and/or Muscle function
Time frame: baseline, 6 months and 12 months
Isokinetic
Sarcopenia
Time frame: baseline, 6 months and 12 months
EWGSOP2 description
Frailty
Time frame: baseline, 6 months and 12 months
L Fried Criteria
6 secondary outcomes
Functional Capacity 1
Time frame: baseline, 6 months and 12 months
Functional Capacity 2
Time frame: baseline, 6 months and 12 months
Functional Capacity 3
Time frame: baseline, 6 months and 12 months
Functional Capacity 4
Time frame: baseline, 6 months and 12 months
Functional Capacity 5
Time frame: baseline, 6 months and 12 months
Functional Capacity 6
Time frame: baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Muscle Strengh
Not yet recruiting
Strength for Caregiving
Mental Well-being, Muscle Strengh
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mateu Serra-Prat, MD PhD principal investigator
Fundació Privada Salut del Consorci Sanitari del Maresme
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention in people with Muscle Strengh and Frailty, run by Consorci Sanitari del Maresme at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Mass (time frame: baseline, 6 months and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.