Clinical trial NCT05772910: Viability of an Educational Program for Lifestyle Changes and an Algorithm for the Derivation of Exercise Programs in Older People at Risk of Dependency at Primary Care.
Official title: Viability of an Educational Program for Lifestyle Changes and an Algorithm for the Derivation of Exercise Programs in Older People at Risk of Dependency at Primary Care.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Disability Physical
Old Age; Atrophy
Keywords: Education
Physical Exercise
Aging
Frailty
Dependency
Biomarkers
Older Adults
Machine Learning
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 110
Sex: ALL
Minimum age (years): 70
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: According to the INE in 2021, more than 9 million people are currently over 65 years of age. This means that more than 1 million are frail and almost 4 million are pre-fragile only in Spain. Frailty is the prelude to disability and dependency, but unlike these, it is treatable and preventable. Currently, it is known that the best treatment for frailty is physical exercise and physical activity. The problem arises from the need that exists in the health system to prescribe individualized and patient-centered exercise, with the use of scarce resources (time, personnel, tools) and in a simple way in clinical practice. Additionally, the system needs tools that help us know (and predict) if this exercise prescription is efficient. Furthermore, frailty is a multidimensional syndrome, for which a comprehensive approach is necessary. The combined study of blood and digital biomarkers, as well as the plethora of dimensions evaluated (muscle and physical activity, cognitive, lifestyle, clinical, body composition, social, sleep), constitute an optimal approach that would provide a unique opportunity to understand prevention and treatment of unsuccessful aging and frailty. The PRICA-POWFRAIL project aims to examine the feasibility of an educational intervention to change lifestyle habits as well as the effect of a referral algorithm to an exercise program and lifestyle changes focused on treating specific deficits of low muscle power, powerful predictor of adverse health events. The subsequent referral will be implemented in a supervised exercise program at the functional, cognitive muscle level and in older people at risk of dependence. Secondarily, the effect of this intervention on blood biomarkers (at a genetic, epigenetic and metabolomic level), physical health (functional capacity, blood pressure, body composition) and mental health (quality of life and depression), as well as on other risk factors (genetic and biological) for the development of frailty. A total of 110 people older than 70 years of age in previous stages of dependency will be randomly distributed among the group of an educational program, the intervention group with supervised physical exercise, a intervention group with both previous educational and exercise programs and the control group. The design will include a 10- week intervention with pre and post-intervention measurement phases and a third measurement (retest) 12 months after completion. The supervised physical exercise program will be of a multi-component type including cardiovascular, muscular, coordinative and balance work, and a progression will be established in the different load parameters (frequency, volume, intensity, density). This will allow us to understand from a very complete perspective the causes and mechanisms underlying this response. The PRICA-POWFRAIL project Will mean a significant increase in scientific knowledge about the response and response rate to ultra-individualized exercise programs directed as a therapeutic measure in people at risk of dependency from a multidimensional perspective. In addition, the project will have a relevant impact at the social and economic level by transferring the findings of the study to the social and health field through the agents and means provided in it.


Eligibility criteria: Inclusion Criteria:

Following the 2014 Consensus Document on the prevention of frailty and falls in the elderly patient we will recruit individuals

I) \> 70 years of age

II) with a Barthel Index score \> 75

III) meeting at least one of the following two criteria: a score ≤9 in the short physical performance battery (SPPB) or FRAIL questionnaire with values 1 or 2.

Exclusion Criteria:

I) Inability to go to the Primary Care Health Centre for any reason.

II) Moderate to severe cognitive impairment (Mini-Mental State Examination\< 20 points

III) Severe pathology for which physical activity is contraindicated at the physician's discretion including but not limited to: recent acute myocardial infarction (6 months), uncontrolled cardiac arrhythmia, severe cardiac valve disease, non-controlled hypertension (\> 180/100mmHg), non-controlled/severe heart failure, severe respiratory insufficiency disease, and diabetes mellitus with acute decompensation/frequent hypoglycaemia.

Primary outcomes:
measure: Relative lower limbs muscle power
timeFrame: Change from Baseline STS muscle power at 12 weeks
measure: Vital functional capacity
timeFrame: Change from Baseline Vital functional capacity at 12 weeks
measure: Level of physical activity during the daily life
timeFrame: Change from Baseline Level of physical activity at 12 weeks
Secondary outcomes:
measure: The quality of life (QoL)
timeFrame: Change from Baseline the quality of life at 12 weeks
measure: Subjective health-status level
timeFrame: Change from Baseline the health status level at 12 weeks
measure: Cognitive Function - Mini-mental state examination (MMSE)
timeFrame: Change from Baseline MMSE at 12 weeks
measure: Cognitive Function - The Montreal cognitive assessment test (MoCA)
timeFrame: Change from Baseline MoCA at 12 weeks
measure: Mood State - Geriatric Depression Scale (GDS)
timeFrame: Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks
measure: Nutritional profile measurements - Mediterranean Diet Adherence Screener index
timeFrame: Change from Baseline Nutritional profile at 12 weeks
measure: Degree of frailty - Fried criteria
timeFrame: Change from Baseline frailty degree at 12 weeks
measure: Body composition - Bioimpedance
timeFrame: Change from Baseline Bioimpedance composition at 12 weeks
measure: Body composition - body mass index (BMI)
timeFrame: Change from Baseline body mass index (BMI) at 12 weeks
measure: Body composition - height
timeFrame: Change from Baseline height at 12 weeks
measure: Body composition - weight
timeFrame: Change from Baseline weight at 12 weeks
measure: Musculoskeletal ultrasound architecture
timeFrame: Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks
measure: Depressive Symptoms
timeFrame: Change from Baseline Depressive Symptoms at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Cádiz
name: Alejandro Galan-Mercant, PhD
role: PRINCIPAL_INVESTIGATOR
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