Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280586
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-22
Brief Title:
Effectiveness of Intervention in Prevention of Sarcopenia Frailty and Functional Decline in Pre-frail Community Elderly
Sponsor:
Consorci Sanitari del Maresme
Organization:
Consorci Sanitari del Maresme
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPAI-F
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None