Clinical trial NCT06280586: Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Strengh
Frailty
Sarcopenia
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 232
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Mass
timeFrame: baseline, 6 months and 12 months
measure: Muscle strength and/or Muscle function
timeFrame: baseline, 6 months and 12 months
measure: Sarcopenia
timeFrame: baseline, 6 months and 12 months
measure: Frailty
timeFrame: baseline, 6 months and 12 months
Secondary outcomes:
measure: Functional Capacity 1
timeFrame: baseline, 6 months and 12 months
measure: Functional Capacity 2
timeFrame: baseline, 6 months and 12 months
measure: Functional Capacity 3
timeFrame: baseline, 6 months and 12 months
measure: Functional Capacity 4
timeFrame: baseline, 6 months and 12 months
measure: Functional Capacity 5
timeFrame: baseline, 6 months and 12 months
measure: Functional Capacity 6
timeFrame: baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
city: Mataró
country: Spain
facility: Mateu Serra-Prat
state: Barcelona
Study officials:
affiliation: Fundació Privada Salut del Consorci Sanitari del Maresme
name: Mateu Serra-Prat, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: