ClinicalTrials.gg
CompletedNCT06280586ESPAI-FUpdated Mar 27, 2026

Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly

An interventional study of Multidisciplinary intervention in Muscle Strengh, Frailty and Sarcopenia, sponsored by Consorci Sanitari del Maresme. Completed at 2 sites in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Nov 2021, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 132 studies in Frailty with a site in Spain — 46 open to participants now, 54 under way, none of them phase 3. Frailty · Spain.

Enrollment
16th of 96
232 · median 90
Started
2021
with 7 others
No phase
93 of 132
34 open now
Registered
70th of 132
by date
Lead sponsor
3 of 132
Consorci Sanitari del Maresme

Among the 132 studies in Frailty with a site in Spain, this one is the 16th largest by enrollment of the 96 interventional ones that give a count, is one of 8 that started in 2021, is one of 93 with no phase, and was the 70th registered.

Frailty

1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.

Browse Frailty studies →

Open to participants now

46 of the 132 studies in Frailty with a site in Spain are open now. Recruiting first, the newest first:

41 more — sign in →

All 46 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 299 Frailty studies recruiting now, 235 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.

This study: 70 Years and older · all sexes · no healthy volunteers.

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This tab as a report to print or save as PDF → With an account.

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02

Study 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. 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.

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:

  1. Evaluate the effect of the study intervention in the medium term (1 year) in terms of prevention or improvement of:

    1. Muscle strength, muscle mass and sarcopenia,
    2. The fragility
    3. Functional capacity (and/or dependence), balance and the risk of falls
    4. Nutritional status
    5. The quality of life
    6. The consumption of health resources in pre-frail community elders 70 years or older.
  2. To evaluate the safety of the mid-term study intervention (1 year) in pre-frail community elders aged 70 years or older.

Secondary objectives:

  1. Assess the degree of adherence to the study intervention.
  2. Evaluate the factors related to good adherence to the study intervention.
  3. 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).
  4. Describe the survival of the study sample and find out what the main determinants are (longitudinal analysis).
03

Conditions studied

  • Muscle Strengh
  • Frailty
  • Sarcopenia
04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • 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
  • of less than 6 months
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
232 participants (actual)

Study arms

  • No intervention
    Control

    Usual clinical practice

  • Experimental
    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: Multidisciplinary intervention

Interventions

  • OtherMultidisciplinary 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.

06

What researchers measure

Primary outcomes

  1. Muscle Mass

    Bioimpedance

    Time frame: baseline, 6 months and 12 months

  2. Muscle strength and/or Muscle function

    Isokinetic

    Time frame: baseline, 6 months and 12 months

  3. Sarcopenia

    EWGSOP2 description

    Time frame: baseline, 6 months and 12 months

  4. Frailty

    L Fried Criteria

    Time frame: baseline, 6 months and 12 months

Secondary outcomes

  1. Functional Capacity 1

    Barthel index

    Time frame: baseline, 6 months and 12 months

  2. Functional Capacity 2

    Lawton index

    Time frame: baseline, 6 months and 12 months

  3. Functional Capacity 3

    Timed up and go test

    Time frame: baseline, 6 months and 12 months

  4. Functional Capacity 4

    SPPB

    Time frame: baseline, 6 months and 12 months

  5. Functional Capacity 5

    Unipodal test

    Time frame: baseline, 6 months and 12 months

  6. Functional Capacity 6

    Walking speed mesured by looking time to walk 4.6 meters

    Time frame: baseline, 6 months and 12 months

07

Study locations

2 sites
  • Consorci Sanitari del Maresme
    Mataró, Barcelona 08304, Spain
  • Mateu Serra-Prat
    Mataró, Barcelona 08304, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Oct 2023, 23 months.

Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 23 months is close to that.

Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2023
First posted
Feb 28, 2024
StartActual
Nov 15, 2021
Primary completionActual
Oct 30, 2023
CompletionActual
Dec 31, 2024
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06280586
Lead sponsor
Consorci Sanitari del Maresme
Responsible party
Mateu Serra Prat (MD PhD, Consorci Sanitari del Maresme) — Principal investigator
First posted
Feb 28, 2024
Start date
Nov 15, 2021
Primary completion
Oct 30, 2023
Completion
Dec 31, 2024
Last update
Mar 27, 2026

Study contacts

Mateu Serra-Prat, MD PhD
principal investigator · Fundació Privada Salut del Consorci Sanitari del Maresme

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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