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

ConditionsAppetite Loss in AgingAnorexia of Aging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical activity

    Other intervention

    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 intervention

    The appetite will be evaluated by a self-assessment questionnaire SNAQ.

  • Food intake assessment

    Other intervention

    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 intervention

    It will be evaluated by a self-assessment questionnaire EQ-5D-5L.

  • Blood test at baseline

    Biological/Vaccine

    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/Vaccine

    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 intervention

    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 intervention

    the weight will be measured every month (kilogramm).

Treatment groups

596 Participants
are divided into 2 treatment groups
Group A: InterventionalExperimental treatment 8 interventions
Group B: ObservationalOther 6 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: