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

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.

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Sarcopenia; Muscle Strengh
• Intervention / Treatment: Other: Multidisciplinary intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Consorci Sanitari Del Maresme
    • Mataró, Barcelona, Spain, 08304
      • Mateu Serra-Prat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 informed consent to participate in the study.

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
• Life expectancy 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 malnutritionDietary and physical exercise recommendations in obese elderlyGeneral physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopeniaPhysical exercise recommendations for the elderly at risk of falls.Medication management and social resources for the elderly in Mataró.	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 malnutritionDietary and physical exercise recommendations in obese elderlyGeneral physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopeniaPhysical exercise recommendations for the elderly at risk of falls.Medication management and social resources for the elderly in Mataró.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	Bioimpedance	baseline, 6 months and 12 months
Muscle strength and/or Muscle function	Isokinetic	baseline, 6 months and 12 months
Sarcopenia	EWGSOP2 description	baseline, 6 months and 12 months
Frailty	L Fried Criteria	baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity 1	Barthel index	baseline, 6 months and 12 months
Functional Capacity 2	Lawton index	baseline, 6 months and 12 months
Functional Capacity 3	Timed up and go test	baseline, 6 months and 12 months
Functional Capacity 4	SPPB	baseline, 6 months and 12 months
Functional Capacity 5	Unipodal test	baseline, 6 months and 12 months
Functional Capacity 6	Walking speed mesured by looking time to walk 4.6 meters	baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme
• Investigators: Principal Investigator: Mateu Serra-Prat, MD PhD, Fundació Privada Salut del Consorci Sanitari del Maresme

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia
• Other Study ID Numbers: 44/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No