Clinical trial NCT05249504: Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People
Official title: Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility
Depressive Symptoms
Nutrition, Healthy
Cognitive Decline
Hearing Loss
Visual Impairment
Keywords: Frailty
Intrinsic capacity
Multicomponent intervention
Randomized clinical Trial
Quality of life
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 212
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open and Pragmatic Parallel Randomized Controlled Clinical Trial
Primary purpose: PREVENTION

Brief summary: In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy.

Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice.

Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state.

The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.


Eligibility criteria: INCLUSION CRITERIA

* To live in the community
* To be able to move autonomously to the intervention place
* To Have a deficit in at least one mobility, vitality or psychological domains in the Integrated Care for Older People (ICOPE) screening tool confirmed by a reference test, namely:

A - Mobility: unable to stand up from a chair 5 times in less than 14 seconds AND having less than 10 points in the Short Physical Performance Battery (SPPB).

B - Vitality: any nutritional problem from the ICOPE screening tool (loss of appetite OR losing more than 3 Kg not intentionally in the last 3 months) AND having less than 12 points in MNA (malnutrition or malnutrition risc).

C - Psychological: any depressive symptoms from the ICOPE screening tool (answer that in the last two weeks has had feelings of sadness, melancholy OR hopelessness or refer lack of interest or pleasure when doing things) AND the presence of at least two or more symptoms on the 5-item Geriatric Depression Scale (GDS5).

EXCLUSION CRITERIA

* People with previous diagnosis of dementia or cognitive decline with a score below 24 points in the Minimental State Examination (MMSE).
* People in the end of life.
* People who have factors that prevent or contraindicate the performance of the planned interventions, such as contraindication to physical activity, mental or (non-corrected) communication issues that makes it difficult to participate in group dynamics.

Primary outcomes:
measure: Self-perceived health
timeFrame: Baseline, after the intervention (average 16 weeks)
Secondary outcomes:
measure: Functional status
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Nutritional status
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Depressive symptoms
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Autonomy in daily life.
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Health related quality of life.
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Physical activity.
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Loneliness
timeFrame: Baseline, after the intervention (average 16 weeks)
measure: Social support and risk of isolation
timeFrame: Baseline, after the intervention (average 16 weeks)
Other outcomes:
Locations:
Study officials:
References: