- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04988334
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults (FAST2)
Studieoversigt
Detaljeret beskrivelse
The purpose of this proposed study is to advance our knowledge of this innovative and simple training program, FAST, to determine if it has potential to improve the physical capacity to arrest a fall and reduce injury risk in older community-dwelling women and men. Using our novel lab-based energy absorption and strength measures, we will be able to compare fall-arrest capacity changes in older men and women.This study will also help to inform strategies to engage older men in exercise programming.
Research Goals and Objectives: The principal research questions of this study are:
- Does the FAST improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?,
- Does FAST increase arm muscle strength, response time, mobility and balance control compared to usual activity? ,
- Are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and
- Do men differ from women in their perceptions of the barriers and facilitators to participating in FAST? The hypotheses are that: 1) FAST will result in greater improvements in energy absorption, UE strength, response time and mobility compared to usual activity for both older men and women; however 2) men will demonstrate enhanced fall arrest capacity and 3) will identify unique barriers and facilitators to participation compared to women.
The study is a quasi-experimental pre-post design with a wait list control period where 60 men and women, age 60 years or older will be recruited to participate in FAST.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 2Z4
- University of Saskatchewan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults aged 60 years living in the community
Exclusion Criteria:
- recent upper body injury or pain,
- recent or history of more than one distal radial fracture,
- history of upper extremity neurological conditions or conditions contradicting upper extremity strength testing or training,
- signs of severe cognitive impairment identified with the mini-Cog
- unable to safely ambulate independently in the community
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: FAST
12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women
|
usual activities
|
|
Placebo komparator: wait control
12 weeks of usual activity prior to intervention, same group of men and women
|
usual activities
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle strength dynamic
Tidsramme: 12 weeks
|
concentric and eccentric isokinetic dynamometry
|
12 weeks
|
|
Muscle Strength isometric
Tidsramme: 12 weeks
|
Hand held dynamometry
|
12 weeks
|
|
Muscle Strength isometric
Tidsramme: 12 weeks
|
grip strength
|
12 weeks
|
|
Muscle strength isometric
Tidsramme: 12 weeks
|
push off test
|
12 weeks
|
|
response time
Tidsramme: 12 weeks
|
signal to touch on force plate
|
12 weeks
|
|
Balance
Tidsramme: 12 weeks
|
one leg stand
|
12 weeks
|
|
Balance
Tidsramme: 12 weeks
|
tandem stand
|
12 weeks
|
|
Balance
Tidsramme: 12 weeks
|
modified clinical test of sensory interaction and balancer
|
12 weeks
|
|
Balance Confidence
Tidsramme: 12 weeks
|
Activities balance confidence scale
|
12 weeks
|
|
Fall Risk
Tidsramme: 12 weeks
|
Fall Risk for older people in the community-screen
|
12 weeks
|
|
timed up and go test
Tidsramme: 12 weeks
|
stand, walk 3 meters, turn and return to sit
|
12 weeks
|
|
chair stand
Tidsramme: 12 weeks
|
30-second chair stand test
|
12 weeks
|
|
gait velocity
Tidsramme: 12 weeks
|
timed 6 meters within 10 meter walk
|
12 weeks
|
|
fall landing capacity
Tidsramme: 12 weeks
|
energy absorption, force, elbow range of motion
|
12 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
physical activity
Tidsramme: 12 weeks
|
physical activity scale for the elderly
|
12 weeks
|
|
fall history
Tidsramme: 12 weeks
|
questionnaire
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cathy o Arnold, School of Physical Therapy
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- University of Saskatchewan
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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