- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02393014
Physical Activity and Fall Prevention in Geriatric Inpatients in Acute caRe: Feasibility Study (AGIR)
Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)
Studieoversigt
Detaljeret beskrivelse
Having developed many tools to determine fall risk of 65 years and older patients, Angers University Hospital plans to develop a corrective action to prevent the occurrence of falls in this population.
This study aims to assess the feasibility of a physical activity program with 3 difficulty levels (depending on the patient's risk of falling): easy (low fall risk), moderate (average fall risk) and difficult (high fall risk).
The implementation process should be simply and fastly applicable in practice for routine care by paramedics.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maine et Loire
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Angers, Maine et Loire, Frankrig, 49933
- University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Being 65 years old and older
- Being hospitalized in geriatric acute care unit of Angers University Hospital.
- No contraindications to physical activity practice.
- No contraindications to standing station and sitting station.
- Participants having given and signed an informed participation consent. If the participant is unable to answer, we will retain the disagreement expressed by a trusted person.
- Being affiliated to French social security
Exclusion Criteria:
- Refusal of participation
- Persons aged under 65.
- Topics including hospitalization at the entrance should not exceed 3 days.
- Participation in concomitant clinical trial.
- Civil Protection Measures such as trusteeship, guardianship or backup justice underway.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Low fall risk
low fall risk patients
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Eksperimentel: Medium fall risk
medium fall risk patients
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Eksperimentel: High fall risk
high fall risk patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants in each category of fall risk having realized 75% and more of the exercises of at least one of the three difficulty levels of the physical activity program
Tidsramme: up to 15 months
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The feasibility of the interventions of each fall risk category is defined as "at least 80% of the participants of a category having completed 75% and more of the exercises".
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up to 15 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of number of patients having realized the Five Time Sit and Stand (FTSS) test.
Tidsramme: up to 15 months
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up to 15 months
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For the patients having achieved FTSS test, the realization time (in seconds).
Tidsramme: up to 60 seconds
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up to 60 seconds
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Measure (by the medical team) of the difficulty to set up and carry out the exercises
Tidsramme: up to 20 days
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This measure will be assessed with a scale : "very easy" ; "easy" ; "feasible" ; "difficult" ; "impossible"
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up to 20 days
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Time needed by the paramedical team to achieve the exercises
Tidsramme: up to 20 days
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up to 20 days
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2014-30
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