NCT07831733

Brief Summary

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
596

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Sep 2028

Study Start

First participant enrolled

September 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 10, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

appetite lossphysical activityexerciseolder adultsnursing home

Outcome Measures

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.

    6 months

Secondary Outcomes (15)

  • Changes in the score of the SNAQ questionnaire

    6 months

  • Changes in the nutrition evaluation

    6 months

  • Patients' healthcare consumption

    6 months

  • Efficiency of the physical exercise program assessed using costs from the community's perspective and QALYs

    6 months

  • Baseline blood concentrations of leptin, insulin, and GDF-15 at the inclusion

    On inclusion

  • +10 more secondary outcomes

Study Arms (2)

Interventional

EXPERIMENTAL

Participants in the intervention group will take part in group physical exercise sessions for 6 months (groups of 5 persons).

Other: Physical activityOther: Appetite assessmentOther: Food intake assessmentOther: Assessment of the efficiencyBiological: Blood test at baselineBiological: Blood test at the end of the studyOther: Functional capacities assessmentOther: weight measurment

Observational

OTHER

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 assessmentOther: Food intake assessmentOther: Assessment of the efficiencyBiological: Blood test at baselineOther: Functional capacities assessmentOther: weight measurment

Interventions

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.

Interventional

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

InterventionalObservational

It will be assessed by the healthcare team of the patient at baseline and at the end of the study.

InterventionalObservational

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

InterventionalObservational

A blood test will be done at the beginning of the study to evaluate the blood concentrations of leptin, insulin and GDF-15.

InterventionalObservational

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.

Interventional

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-Ã…sberg Depression Rating Scale (MADRS) and PHQ-2 for mood

InterventionalObservational

the weight will be measured every month (kilogramm).

InterventionalObservational

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

AnorexiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Caroline Berbon, PHD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Berbon, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 21, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations