An interventional study of Physical activity and Appetite assessment in Appetite Loss in Aging and Anorexia of Aging, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention
Appetite loss is frequent in institutionalized older adults. Physical activity is known for its benefits on appetite regulation but its effects in nursing home residents remain poorly investigated. This project will investigate the 6-month longitudinal relationships between daily physical activity time with appetite and bodyweight and how engaging in a 6-month regular exercise program can improve theses outcomes in older institutionalized older adults.
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.
For both the observational and interventional parts:
For the interventional part only:
- Be able to understand instructions for performing the exercises.
Exclusion Criteria:
For both the observational and interventional parts:
Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).
Other: Physical activity · Other: Appetite assessment · Other: Food intake assessment · Other: Assessment of the efficiency · Biological: Blood test at baseline · Biological: Blood test at the end of the study · Other: Functional capacities assessment · Other: weight measurment
Participants will not receive any specific care. They will simply need to wear activity trackers on two separate occasions over the course of a week: from M0 to M0 + 1 week and from M6 to M6 + 1 week.
Other: Appetite assessment · Other: Food intake assessment · Other: Assessment of the efficiency · Biological: Blood test at baseline · Other: Functional capacities assessment · Other: weight measurment
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.
The appetite will be evaluated by a self-assessment questionnaire SNAQ.
It will be assessed by the healthcare team of the patient at baseline and at the end of the study.
It will be evaluated by a self-assessment questionnaire EQ-5D-5L.
A blood test will be done at the beginning of the study to evaluate the blood concentrations of leptin, insulin and GDF-15.
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.
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
the weight will be measured every month (kilogramm).
Changes in bodyweight
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.
Time frame: 6 months
Changes in the score of the SNAQ questionnaire
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).
Time frame: 6 months
Changes in the nutrition evaluation
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.
Time frame: 6 months
Patients' healthcare consumption
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).
Time frame: 6 months
Efficiency of the physical exercise program assessed using costs from the community's perspective and QALYs
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).
Time frame: 6 months
Baseline blood concentrations of leptin, insulin, and GDF-15 at the inclusion
A blood test will be done at baseline to evaluate the blood concentrations of leptin, insulin and GDF-15.
Time frame: On inclusion
Changes in blood concentrations of leptin, GDF-15, and insulin
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).
Time frame: 6 months
Evolution of cognition
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).
Time frame: 6 months
Evolution of nutrition
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).
Time frame: 6 months
Evolution of hearing
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).
Time frame: 6 months
Evolution of vision
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).
Time frame: 6 months
Evolution of mobility: physical performances
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).
Time frame: 6 months
Evolution of mobility: muscular strenght
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).
Time frame: 6 months
Evolution of mood: Depressive symptoms
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).
Time frame: 6 months
Evolution of mood: Sadness symptoms
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).
Time frame: 6 months
Measuring blood biomarkers of neurodegeneration and establishment of a biobank for the measurement of new aging biomarkers
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.
Time frame: 6 months
Plan to share: No
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University Hospital, Toulouse