University Hospital
Toulouse, 31 059, France
NCT Number: NCT07831733
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Toulouse, 31 059, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For both the observational and interventional parts:
For the interventional part only:
Exclusion criteria
For both the observational and interventional parts:
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 :
the weight will be measured every month (kilogramm).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 6 months
It will be evaluated by the self-assessment questionnaire EQ-5D-5L.
It consists of two different components:
It will be assessed at visit 1 (M0) and visit 2 (M6).
Time frame: On inclusion
A blood test will be done at baseline to evaluate the blood concentrations of leptin, insulin and GDF-15.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Acronym: EAT-PA
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