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NCT Number: NCT06280586

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

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.

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Key information

Conditions

Muscle Strengh Atrophy Frailty Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari del Maresme, Mataró, Barcelona, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidisciplinary intervention

Other
  • 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.

Primary outcomes

  1. Muscle Mass

    Time frame: baseline, 6 months and 12 months

    Bioimpedance

  2. Muscle strength and/or Muscle function

    Time frame: baseline, 6 months and 12 months

    Isokinetic

  3. Sarcopenia

    Time frame: baseline, 6 months and 12 months

    EWGSOP2 description

  4. Frailty

    Time frame: baseline, 6 months and 12 months

    L Fried Criteria

Secondary outcomes

  1. Functional Capacity 1

    Time frame: baseline, 6 months and 12 months

    Barthel index

  2. Functional Capacity 2

    Time frame: baseline, 6 months and 12 months

    Lawton index

  3. Functional Capacity 3

    Time frame: baseline, 6 months and 12 months

    Timed up and go test

  4. Functional Capacity 4

    Time frame: baseline, 6 months and 12 months

    SPPB

  5. Functional Capacity 5

    Time frame: baseline, 6 months and 12 months

    Unipodal test

  6. Functional Capacity 6

    Time frame: baseline, 6 months and 12 months

    Walking speed mesured by looking time to walk 4.6 meters

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Official study 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.

Acronym: ESPAI-F

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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