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Clinical Trials/NCT02044783
NCT02044783
Completed
Not Applicable

Identifying and Treating Physical Function Impairment in Elders

University of Colorado, Denver1 site in 1 country3 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Colorado, Denver
Enrollment
3
Locations
1
Primary Endpoint
Changes in physical activity as determined by accelerometer
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
September 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Changes in physical activity as determined by accelerometer

Time Frame: 12 weeks

Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.

Changes in physical function as assessed by 400-meter walk speed

Time Frame: 12 weeks

Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.

Changes in physical function as assessed by Short Physical Performance Battery

Time Frame: 12 weeks

Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention

Change in physical function as assessed by lower extremity strength testing

Time Frame: 12 weeks

Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .

Secondary Outcomes

  • Evaluation of standard implementation science process of reach(1 year)
  • Assessment of standard implementation science process metrics of acceptability(1 year)
  • Assessment of standard implementation science process metrics of implementation(1 year)

Study Sites (1)

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