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 Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Frailty, Disability Physical, Old Age; Atrophy

Intervention / Treatment
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* Behavioral: EDUcation
* Other: EXERcise
* Other: EDU-EXER
* Other: CONtrol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDUcation<br>The EDU group will assist to an individualized educative program based on intrinsic capacity optimization through lifestyle changes. | Behavioral: EDUcation<br>* The education intervention will consist of an individualized educative program based on intrinsic capacity optimization through lifestyle changes. To develop the program, the program creation team will be multidisciplinary (psychologists, medical doctor, dietitian…) and will discuss goal setting, the education strategy, and retention of motivation. The experts are required to create the education program such that the participants can manage their health by themselves. The goal will be self-management of dietary habits and increases in physical activity levels for each individual case. The education program will be in Spanish or in English; as it will consist in personal counselling, even with a low level of the language the communication will be possible. The nutritional education program will be conducted every 2 weeks for 10 consecutive weeks, with 20-min counselling sessions by an expert.<br>* Other names: EDU;|
| Experimental: EXERcise<br>The EXER group will follow a program focused on the specific deficit of muscular power from a simple clinical test such as the STS and, in addition, they will be evaluated to be able to prescribe training individually (evaluation of training) | Other: EXERcise<br>* The intervention period will have 10 weeks, in which the EXER group will carry out 2-3 sessions a week (total of 20-30 sessions). In this concurrent program, exercises of the lower extremities (leg press, abduction and plantar flexion) will be performed mainly on weight training machines. Intensity in each exercise will be individualized for each participant through a test to determine muscle power. In addition, in the last part of each session the participants will perform an endurance training type high insensitive interval training on a cycle ergometer (60-80 rpm). The intensity will be individualized to each patient through an incremental stress test until volitional exhaustion, and the subjects will alternate intervals of 30 seconds at 90% of the maximum workload, with intervals of 90 seconds at 40% of the maximum. Each session is estimated to have a total duration of 30-50 minutes.<br>* Other names: EXER;|
| Experimental: EDU-EXER<br>EDU-EXER group subject develops both interventions together. | Other: EDU-EXER<br>* This group will carry out the same two previous interventions together.<br>|
| Active Comparator: CONtrol<br>CON group will continue the usual clinical treatment and their normal life. | Other: CONtrol<br>* CONtrol group will continue the usual clinical treatment and their normal life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative lower limbs muscle power | The STS muscle power test was used to assess mechanical power. Participants were instructed to perform 5 timed STS repetitions after the cue ready, set, go!, as fast as possible, on a standardized armless chair (height = 0.43 m) with arms crossed over the chest. Importantly, from the sitting position, they had to fully extend their knees and hips to the standing position, and descend to the sitting position until at least touching the chair with their buttocks. The test was repeated when any of these instructions was broken. The time (±0.01 s) needed to perform 5 STS repetitions was recorded using a stopwatch. Absolute STS muscle power (W) was calculated using an equation where body mass is indicated in kg, body height and chair height in m, and five STS time in s (Alcazar et al. 2018). Alcazar, J. et al. The sit-to-stand muscle power test: An easy, inexpensive and portable procedure to assess muscle power in older people. Exp Gerontol 112, 38-43 (2018). | Change from Baseline STS muscle power at 12 weeks | 
| Vital functional capacity | The vital functional capacity will be evaluated through cardiorespiratory function using an indirect test adapted to the age range (field tests, which allow obtaining an estimated value of maximum oxygen consumption, the best integral marker of the physiological reserve of an individual, namely 6minute walking test or the 2 min-version which is highly correlated. | Change from Baseline Vital functional capacity at 12 weeks | 
| Level of physical activity during the daily life | Measured by accelerometry for 1 week in evaluation timepoints. | Change from Baseline Level of physical activity at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life (QoL) | EQ-5D which measures health-related QoL through physical, psychological and social dimensions. | Change from Baseline the quality of life at 12 weeks | 
| Subjective health-status level | SF-36 questionnaire which measures the subjective health-status level. | Change from Baseline the health status level at 12 weeks | 
| Cognitive Function - Mini-mental state examination (MMSE) | The mini-mental test is a simple test that allows detecting the presence of cognitive impairment, that is, of dementia. It can be normal in people with mild cognitive impairment or with incipient forms of Alzheimer's requiring, in these cases, studies with more sophisticated tests. | Change from Baseline MMSE at 12 weeks | 
| Cognitive Function - The Montreal cognitive assessment test (MoCA) | The Montreal cognitive assessment test (MoCA) is a brief instrument with which, in a specific way, mild cognitive impairment is detected, as well as dementia. | Change from Baseline MoCA at 12 weeks | 
| Mood State - Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a Yes/No format. The GDS was originally developed as a 30-item instrument. Since this version proved both time-consuming and difficult for some patients to complete, a 15-item version was developed. | Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks | 
| Nutritional profile measurements - Mediterranean Diet Adherence Screener index | 1. MEDAS (Mediterranean Diet Adherence Screener index). Scale of adherence to the Mediterranean diet of 14 items. | Change from Baseline Nutritional profile at 12 weeks | 
| Degree of frailty - Fried criteria | The Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity. | Change from Baseline frailty degree at 12 weeks | 
| Body composition - Bioimpedance | The body composition will be evaluated by means of bioimpedance. | Change from Baseline Bioimpedance composition at 12 weeks | 
| Body composition - body mass index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | Change from Baseline body mass index (BMI) at 12 weeks | 
| Body composition - height | Height measure in meter | Change from Baseline height at 12 weeks | 
| Body composition - weight | Weight measure in kilograms | Change from Baseline weight at 12 weeks | 
| Musculoskeletal ultrasound architecture | All ultrasound images will be acquired by the same operator with the same ultrasound device throughout the whole study using a linear 40 mm transducer and a phased array transductor, and images will be analysed through the ACSAuto script to semi-automatically evaluate ultrasound pictures. The vastus lateralis architecture will be analysed through the Simple Muscle Architecture Analysis tool for Fiji. These procedures will be done according to Rodriguez-López et al. Rodriguez-Lopez, C. et al. Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial. Front Physiol 12, (2021). | Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks | 
| Depressive Symptoms | The depressive symptoms will be assessed with the Geriatric Depression scale to assess psychology status of the participants. | Change from Baseline Depressive Symptoms at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Education, Physical Exercise, Frailty, Dependency, Biomarkers, Older Adults, Machine Learning