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

Sarcopenia Clinical Trial

— ESPAI-F  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06280586
• Other study ID #: 44/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Maresme	Mataró	Barcelona
Spain	Mateu Serra-Prat	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Mass	Bioimpedance	baseline, 6 months and 12 months
Primary	Muscle strength and/or Muscle function	Isokinetic	baseline, 6 months and 12 months
Primary	Sarcopenia	EWGSOP2 description	baseline, 6 months and 12 months
Primary	Frailty	L Fried Criteria	baseline, 6 months and 12 months
Secondary	Functional Capacity 1	Barthel index	baseline, 6 months and 12 months
Secondary	Functional Capacity 2	Lawton index	baseline, 6 months and 12 months
Secondary	Functional Capacity 3	Timed up and go test	baseline, 6 months and 12 months
Secondary	Functional Capacity 4	SPPB	baseline, 6 months and 12 months
Secondary	Functional Capacity 5	Unipodal test	baseline, 6 months and 12 months
Secondary	Functional Capacity 6	Walking speed mesured by looking time to walk 4.6 meters	baseline, 6 months and 12 months