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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Physical Impairment
• Intervention / Treatment: Behavioral: Behavioral Counseling

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Intervention; Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers	Behavioral: Behavioral Counseling
No Intervention: Usual Care; Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic). No behavioral counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in physical activity as determined by accelerometer	Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.	12 weeks
Changes in physical function as assessed by 400-meter walk speed	Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.	12 weeks
Changes in physical function as assessed by Short Physical Performance Battery	Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention	12 weeks
Change in physical function as assessed by lower extremity strength testing	Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of standard implementation science process of reach	Reach is the percent of patients consented divided by the number eligible.	1 year
Assessment of standard implementation science process metrics of acceptability	Acceptability will be assessed through structured surveys.	1 year
Assessment of standard implementation science process metrics of implementation	Implementation process will be assessed by structured surveys	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Amy Huebschmann, MD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Adults
• Other Study ID Numbers: 13-3021