Study on the Prevention of Weight Loss Through Physical Activity Among Nursing Home Residents

With a prevalence that can exceed 30% in institutional settings, loss of appetite and weight loss are associated with an increased risk of mortality and adverse health conditions. Currently, no validated treatment exists to combat appetite loss. Physical activity is an effective strategy for regulating weight and appetite in adults, but its effect in older adults remains poorly established. The few studies conducted in nursing homes have not revealed a cross-sectional link between appetite and physical activity levels, nor any effect of an exercise-based intervention on appetite. However, in independent older adults, studies have shown a favorable link between physical activity levels and appetite, as well as significant effects of regular exercise programs on weight and blood markers of appetite. Thus, research on older adults is limited, and no studies have explored the longitudinal relationship between appetite and PA in institutionalized individuals, who are the most exposed to these symptoms.

The proposed study is a 6-month multicenter quasi-experimental longitudinal study divided into two parts: a longitudinal observational cohort and an interventional component. Residents included in the observational part will not receive any specific treatment but their daily physical activity levels will be assessed through accelerometers that will be worn for one week at both baseline and 6-months visits. Subjects included in the interventional part will participate in physical exercise sessions twice a week for 6 months.

The follow-up of participants will involve bodyweight measurements each month from baseline to 6 months and appetite assessment at baseline and 6 months. This study will investigate how daily physical activity time will be associated with the changes in body weight and appetite over 6 months, and how participating in a 6-month regular exercise program affect body weight and appetite compared to individuals who do not engage in such programs.

• Physical activity (Other): The participants will partake in physical activity sessions twice a week for about 45-60 minutes each which will consist of exercises designed to improve mobility, motor skills, balance, strength and muscular endurance, as well as the cardiorespiratory system. All exercises will be tailored to each person's abilities and can be performed while sitting or standing.
• Appetite assessment (Other): The appetite will be evaluated by a self-assessment questionnaire SNAQ.
• Food intake assessment (Other): It will be assessed by the healthcare team of the patient at baseline and at the end of the study.
• Assessment of the efficiency (Other): It will be evaluated by a self-assessment questionnaire EQ-5D-5L.
• Blood test at baseline (Biological): A blood test will be done at the beginning of the study to evaluate the blood concentrations of leptin, insulin and GDF-15.
• Blood test at the end of the study (Biological): It will be done at the end of the study (month 6) to evaluate the changes in blood concentrations of leptin, insulin and GDF-15.
• Functional capacities assessment (Other): The functional capacities will be assessed by : * Mini-Mental State Examination (MMSE) for cognition * Mini Nutritional Assessment (MNA) short form for nutrition * Whisper test for hearing * step-1 ICOPE question for vision * Short Physical Performance Battery (SPPB) and grip strength for mobility * Montgomery-Åsberg Depression Rating Scale (MADRS) and PHQ-2 for mood
• weight measurment (Other): the weight will be measured every month (kilogramm).

Primary outcomes

• Changes in bodyweight [6 months]: It will be assessed by measuring the bodyweight (kg) seven times (initially and once a month). For the observational arm, it will be measured based on daily physical activity (min/day) as measured by activity trackers. For the interventional arm, it will be measured based on participation in the physical activity program (ratio of sessions attended to sessions scheduled) over a 6-months period.

Secondary outcomes

• Changes in the score of the SNAQ questionnaire [6 months]: It consists of 4 items on a 5-point scale each to evaluate the appetite on a scale of 4 to 20. A score of 14 or less indicates a risk of 5% weight loss. It will be assessed at visit 1 (M0) and visit 2 (M6).
• Changes in the nutrition evaluation [6 months]: The food in-take of patients will be assessed by the nursing home team. The assessment is scored in points, each of which represents 160 Kcal. It will be measured at baseline and 6 months.
• Patients' healthcare consumption [6 months]: It will be based on the number of hospitalizations, consultations, medical and paramedical procedures, medications, medical devices, and transportation used. The datas will be collected retrospectively from the National System of Health Datas (SNDS).
• Efficiency of the physical exercise program assessed using costs from the community's perspective and QALYs [6 months]: It will be evaluated by the self-assessment questionnaire EQ-5D-5L. It consists of two different components: * A component comprising 5 dimensions (mobility, functional independence, daily activities, pain or discomfort and anxiety or depression), each described by 5 levels defining differents health status * A visual analog scale on which patients rate their perceived health on a scale ranging from 0 to 100 (0 being the worst possible condition and 100 being the best). It will be assessed at visit 1 (M0) and visit 2 (M6).
• Baseline blood concentrations of leptin, insulin, and GDF-15 at the inclusion [On inclusion]: A blood test will be done at baseline to evaluate the blood concentrations of leptin, insulin and GDF-15.
• Changes in blood concentrations of leptin, GDF-15, and insulin [6 months]: Only the participants in the interventional arm will get through a second blood test to evaluate the changes in concentrations of leptin, GDF-15 and insulin over the course of 6 months. It will be done at visit 2 (M6).
• Evolution of cognition [6 months]: It will be assessed by the Mini-Mental State Examination (MMSE): it consists of 6 parts (orientation, learning, attention and calculus, reminder, language and constructive practices) resulting in a total score ranging between 0 and 30 (30 representing normal cognitive function). It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of nutrition [6 months]: It will be assessed by the Mini Mental State Examination MNA (short version). It consists of 6 questions about recent loss of appetite and weight loss, the person's motor function, the presence of stress or an acute illness within the past 3 months, neuropsychological impairment (depression or dementia), and body mass index (BMI). It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of hearing [6 months]: It will be assessed by a whisper test. The evaluator stands behind the person, about 60 cm away, and whispers four words of 2 or 3 syllables into each ear. The resident must cover the untested ear by pressing on the tragus of the ear. It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of vision [6 months]: It will be assessed by step 1 ICOPE question: asks the person about any impairment of distance or near vision while wearing glasses, the presence of eye diseases, pain, or eye discomfort, diabetes, high blood pressure, or whether they are taking corticosteroids or eye medication. If the answer is "yes" to at least one of these items, then vision is considered impaired. It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of mobility: physical performances [6 months]: It will be assessed by the Short Physical Performance Battery (SPPB) which evaluates the walking speed (4 meters test), the ability to get up from a chair 5 times and balance. It will be assessed at visit 1 (M0) and visit 2 (M6). It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of mobility: muscular strenght [6 months]: It will be assessed by a grip strength test which evaluates the global muscular strength of the dominant arm via a Jamar dynamometer. It will be assessed at visit 1 (M0) and visit 2 (M6).
• Evolution of mood: Depressive symptoms [6 months]: It will be assessed by the Montgomery Asberg Depression Rating Scale (MADRS). It evaluates the presence and gravity of a depressive syndrom comprising 10 questions made of 6 levels each. It will be completed by the healthcare team at visit 1 (M0) and visit 2 (M6).
• Evolution of mood: Sadness symptoms [6 months]: It will be assessed by the PHQ-2 (self-assessment questionnaire) made of two questions: presence of a depressive or sadness symptom and loss of interest or enjoyment in doing things. It will be assessed at visit 1 (M0) and visit 2 (M6).
• Measuring blood biomarkers of neurodegeneration and establishment of a biobank for the measurement of new aging biomarkers [6 months]: It will be done thanks to the blood tests done during visit 1 (M0) and visit 2 (M6) for the interventional arm and during visit 1 + 1 week only for the observational arm.

Sex: All, ages: 65 Years to any

Inclusion Criteria:

For both the observational and interventional parts:

* Be a resident in a nursing home (EHPAD).
* Be affiliated with the social security system.
* Be aged 65 years or older.
* Have a GIR score > 2.
* Be able to walk 4 meters (with a walking aid if necessary, but without human assistance).
* Provide written consent

For the interventional part only:

\- Be able to understand instructions for performing the exercises.

Exclusion Criteria:

For both the observational and interventional parts:

* Unstable cardiovascular disease or any other health condition contraindicating physical exercise.
* End-of-life situation identified in the medical record.
* Planned relocation to another facility during the 6-month follow-up period.
* To be under legal protection or guardianship

• Caroline Berbon, PHD, Principal investigator, University Hospital, Toulouse