Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Anschutz Medical Campus
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
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Geen tussenkomst: Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in physical activity as determined by accelerometer
Tijdsspanne: 12 weeks
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Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by 400-meter walk speed
Tijdsspanne: 12 weeks
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Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by Short Physical Performance Battery
Tijdsspanne: 12 weeks
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Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
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12 weeks
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Change in physical function as assessed by lower extremity strength testing
Tijdsspanne: 12 weeks
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Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluation of standard implementation science process of reach
Tijdsspanne: 1 year
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Reach is the percent of patients consented divided by the number eligible.
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1 year
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Assessment of standard implementation science process metrics of acceptability
Tijdsspanne: 1 year
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Acceptability will be assessed through structured surveys.
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1 year
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Assessment of standard implementation science process metrics of implementation
Tijdsspanne: 1 year
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Implementation process will be assessed by structured surveys
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1 year
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amy Huebschmann, MD, University of Colorado - Anschutz Medical Campus
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 13-3021
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