Clinical trial NCT05726214: Exercise Program for Maintaining Physical Function and Frailty on Dwelling Older Adults
Official title: Effectiveness of the Fragicare Exercise Program on Functional and Socio-sanitary Management Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Keywords: exercise
physical activity
funcionality
elderly
dwelling
socio-sanitary management
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Due to the difficulties observed during the recruitment, an allocation based on participants' will was conducted to ensure attendance. Thus, participants were allocated by convenience into two groups
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Older people living in their homes and receiving social assistance are at a high risk of suffering functional loss, hospitalization and/or developing disability. This condition is known as frailty. Exercise programs including strength, balance and flexibility training have demonstrated to prevent, delay or even treat frailty. However, participation in this type of exercise programs is very limited in the group of older adults mentioned above.

The present study seeks to evaluate the effects of an exercise program designed to maintain or improve physical function and frailty. The hypothesis is that people who participate in the physical exercise program will maintain or improve their physical capacity, their frailty and psycho-affective status, their quality of life, and generate a lower demand for social and health services compared to those people who do not exercise.

Detailed description: Frailty is recognized as a syndrome that encompasses a high risk of suffering functional loss, hospitalization and/or developing dependency, among other adverse health events. It is considered a modifiable factor, capable of being reversed if intervention is made in the early stages of its development. The implementation of multicomponent physical exercise programs has been proven to prevent, delay or even treat frailty. However, participation in this type of exercise programs is very limited in older people living in their homes and receiving social assistance. Social assistance in Spain is recognized as a care and preventive nature service intended to help older adults in a situation of dependency, or risk of dependency, to remain at their homes, offering them the required domestic and personalized assistance that enables their development in their own homes and their integration into the community environment, avoiding situations of isolation. Older people living in their homes and receiving social assistance population is characterized by being particularly vulnerable, since it presents high rates of frail people that are in the initial stages of dependency, which makes them a target to significantly benefit from the effects of exercise.

The approach to tackling frailty has become a Public Health priority at a European, state and regional level, as it affects both the health and social systems in an increasingly aging society. Nevertheless, there are currently no frailty management models in an integrated manner between health and social service systems. In this context arises the FRAGICARE project, which aspires to develop a model of shared health and social management, sustainable in the long term, which promotes the permanence of the older adults in their usual social environment, respecting their lifestyles and preferences. This model is supported by a digital platform uploaded in the cellular, fed by the data collected by the professionals who are in charge of the home care service provided to the dwelling older adults. In the event of a significant change in the conditions that affect these older adults (fall, reduction in functional level, modification of the nutritional pattern, change in the social network, ...), the platform generates a series of alarms that are referred to their healthcare and/or social professional, who will reassess and, if necessary, adjust the care plan. These alarms have been defined by a multidisciplinary group of experts and piloted in a previous project. In this way, the model seeks to provide individualized, continuous and coordinated care between the basic social services system and the health system (primary and specialized care services).

The objective of the present study is to assess the effects of a physical exercise program from a multidimensional perspective, including physical function, frailty status, psycho-affective parameters, and quality of life. In addition, we will also evaluate the effect of the program in the number of alarms generated by the digital platform to the social and health services.

The hypothesis is that people who participate in the physical exercise program will maintain or improve their physical function, their frailty status, psycho-affective capacity, quality of life, and generate a lower number of social and health services alarms compared to those people who do not exercise.

Eligibility criteria: Inclusion Criteria:

* 60 years or older.
* Home care users managed by the municipal social network.
* In a stable situation (no worsening, no convalescence, no hospital discharge).
* Frail or pre-frail individuals.

Exclusion Criteria:

* At the end of life.
* \<60 on the Barthel Index.
* Cognitive impairment that affects their decision-making ability (Mini Mental State Examination, MMSE \<24).
* Subjects that, on Home Care Service's assistant's criteria, do not meet the conditions to be included in the study.

Primary outcomes:
measure: Change from baseline Short Physical Performance Battery (SPPB) total score at 4 months
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change from baseline Fried's frailty phenotype score at 4 months
timeFrame: Baseline and 6 months
measure: Change from baseline height at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline weight at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline hand grip at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Eight Foot up and Go (8-FUG) at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Nutritional state at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Cognition at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Anxiety and Depression at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline health-related quality of life at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Meaning in Life Questionnaire score at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Satisfaction With Life Scale score at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline Subjective Happiness Scale score at 4 months
timeFrame: Baseline and 4 months
measure: Sociodemographic information
timeFrame: Baseline and in any moment that any of them might change (place of residence, cohabitation model and social network) up to 4 months.
measure: Number of falls
timeFrame: From baseline assessment up to 4 months
measure: Attendance to the face-to-face exercise sessions
timeFrame: From the first session up to the last one during the 4 months
measure: Attendance to the autonomous sessions at home
timeFrame: From the first session up to the last one during the 4 months
measure: Alarms to the social and health care services
timeFrame: Daily from baseline assessment up to 4 months
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: University of the Basque Country
state: Bizkaia
Study officials:
affiliation: UPV/EHU
name: Ana AR Rodriguez Larrad
role: PRINCIPAL_INVESTIGATOR
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