Identifying and Treating Physical Function Impairment in Elders

Physical Activity Clinical Trial

Official title:

Identifying and Treating Physical Function Impairment in Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044783
• Other study ID #: 13-3021
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Physical Impairment

Intervention

Behavioral:
• Behavioral Counseling

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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