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

NCT06280586 | Completed

• 1 other identifier: 44/21
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Muscle Strengh; Frailty; Sarcopenia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Functional Capacity 1

  baseline, 6 months and 12 months

• Functional Capacity 2

  baseline, 6 months and 12 months

• Functional Capacity 3

  baseline, 6 months and 12 months

• Functional Capacity 4

  baseline, 6 months and 12 months

• Functional Capacity 5

  baseline, 6 months and 12 months

Study Arms (2)

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.

Other: Multidisciplinary intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (2)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

Mateu Serra-Prat

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Mateu Serra-Prat, MD PhD

  Fundació Privada Salut del Consorci Sanitari del Maresme

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 28, 2024
• Study Start: November 15, 2021
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)