Identifying and Treating Physical Function Impairment in Elders

Not Applicable

Completed

• Conditions: Physical Activity; Physical Impairment
• Interventions: Behavioral: Behavioral Counseling

• Registration Number: NCT02044783
• Lead Sponsor: University of Colorado, Denver

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention	Behavioral Counseling	Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers

Primary Outcome Measures

Name	Time	Method
Changes in physical activity as determined by accelerometer	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	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	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	12 weeks	Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States