Clinical trial NCT02044783: Identifying and Treating Physical Function Impairment in Elders
Official title: Identifying and Treating Physical Function Impairment in Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Physical Impairment
Keywords: Adults
Elderly
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in physical activity as determined by accelerometer
timeFrame: 12 weeks
measure: Changes in physical function as assessed by 400-meter walk speed
timeFrame: 12 weeks
measure: Changes in physical function as assessed by Short Physical Performance Battery
timeFrame: 12 weeks
measure: Change in physical function as assessed by lower extremity strength testing
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluation of standard implementation science process of reach
timeFrame: 1 year
measure: Assessment of standard implementation science process metrics of acceptability
timeFrame: 1 year
measure: Assessment of standard implementation science process metrics of implementation
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy Huebschmann, MD
role: PRINCIPAL_INVESTIGATOR
References: