- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04988334
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults (FAST2)
Studieoversikt
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 2Z4
- University of Saskatchewan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
physical activity
Tidsramme: 12 weeks
|
physical activity scale for the elderly
|
12 weeks
|
|
fall history
Tidsramme: 12 weeks
|
questionnaire
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cathy o Arnold, School of Physical Therapy
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- University of Saskatchewan
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IPD-planbeskrivelse
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